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Background: Residual limb volume may change after doffing, affecting the limb shape measured and used as a starting point for socket design.Objectives: The purpose of this study was to compare residual limb fluid volume changes after doffing for different test configurations.Study Design: The study was a repeated measures experimental design with three conditions (Sit, Liner, and Walk).Methods: Residual limb fluid volume on 30 people with trans-tibial amputation was measured using bioimpedance analysis. Three tests were conducted--Sit: sit for 10 minutes, remove the prosthesis, socks and liner, sit for 10 minutes; Liner: sit for 10 minutes, remove the prosthesis and socks but not the liner, sit for 10 minutes; Walk: conduct sit, stand and walk activities for 30 minutes, remove the prosthesis, socks and liner, sit for 10 minutes.Results: The percentage fluid volume increase after doffing was significantly higher for Walk (2.8%) than for Sit (1.8%) (p = 0.03). The time to achieve a maximum or stable fluid volume was shorter for Liner (4.3 min) than for Sit (6.6 min) (p = 0.03).Conclusions: Activity before doffing intensified the post-doffing limb fluid volume increase. Maintaining a liner after doffing caused limb fluid volume to stabilize faster than removing the liner. Clinical relevance To minimize residual limb volume increase before casting or imaging, practitioners should have patients sit with their prosthesis donned for 10 minutes. Leaving a liner on the residuum will not reduce the post-doffing volume increase, but it will help to more quickly achieve a consistent limb fluid volume. [ABSTRACT FROM AUTHOR]

Background: It is estimated that only 24% of practitioners use CAD/CAM regularly. Socket manufacturing error may be a source of the limited use of central fabrication.Objectives: The purpose of this study was to investigate the differences in shape between computer-manufactured, centrally fabricated carved models and electronic file shapes, to determine if carving was a major source of socket manufacturing error in central fabrication.Study Design: Experimental, mechanical assessment.Methods: Three different trans-tibial model shapes were sent electronically to each of 10 central fabrication facilities for the fabrication of positive foam models. A custom mechanical digitizer and alignment algorithm were used to measure the model shapes and then compare them with the electronic file shapes.Results: Volume differences between the models and the electronic file shapes ranged from -4.2% to 1.0%, and averaged -0.9 (SD = 1.1)%. Mean radial error ranged from -1.2 mm to 0.3 mm and averaged -0.3 (SD = 0.3) mm. Inter-quartile range was between 0.3 mm and 2.7 mm and averaged 0.6 (SD = 0.5) mm. The models were significantly smaller than sockets made from the same electronic file shapes (p < 0.01), but the range of mean radial error and the interquartile range were not significantly different between the models and sockets.Conclusions: The results demonstrated that there was considerable variability in model quality among central fabricators in the industry, and that carving was not the sole source of socket fabrication error.Clinical Relevance: The results provide insight into the severity and nature of carving error by central fabrication facilities. Because we found a wide range of model quality, there is not a consistent fabrication problem across the industry, but instead some central fabrication facilities practice the art of model fabrication better than others. [ABSTRACT FROM AUTHOR]

BACKGROUND AND PURPOSE: Exercise has been shown to improve physical function in frail older adults; however, the effects of exercise may vary with degree of frailty, the format and intensity of the exercise intervention, and level of supervision. This cohort study describes the effects of participation in a 6-week home-based exercise program on measures of physical function as well as exercise-related beliefs, including exercise self-efficacy and outcomes expectation, in frail older adults. METHODS: Participants were 72 frail older adults who participated in a 6-week home-based exercise program supervised by graduate physical therapy students. Individualized home-based exercises targeted strength, flexibility, balance, gait, and cardiovascular fitness. Physical function was measured at baseline and after completion of the 6-week exercise program using the Functional Fitness Test (Biceps Curl, Chair Stand, 8-Foot Up and Go) and velocity on a 4-m walk. Measures of exercise-related beliefs included the Self-Rated Abilities for Health Practices Scale and Exercise Outcome Expectations. OUTCOMES: Participation in the 6-week home-based exercise program was associated with improvements in measures of physical function, including an average increase of 3 repetitions (35%) on the biceps curl, 2.4 repetitions (59%) on the chair stand, and an average increase of 0.17 m/s (33%) in gait velocity. Average decrease in Timed Up and Go test scores was 5.7 seconds (26%). Scores for exercise-related beliefs also improved (self-efficacy average increase was 7 points [40%], and average increase in outcome expectations was 3 [47%]). DISCUSSION: A supervised 6-week, multidimensional home-based exercise program was safe and associated with improvements in physical and exercise-related belief outcome measures in this cohort study of frail older adults. [ABSTRACT FROM AUTHOR]

Purpose. By using a combination of qualitative and quantitative methods, the focus of this study was to describe the changes associated with burns on the lives of Brazilian burn victims during the rehabilitation phase, and to investigate possible associations between the changes in work reported by the participants and the percentage of total body surface area burnt, and the body areas affected by the injury. Method. Participants were 18 years of age or older, who had been discharged from hospitalisation between 6 months and 1 year before the interview, or who underwent reconstructive surgery during the previous year, or who were under outpatient follow-up awaiting reconstructive surgery. Data were collected by means of semi-structured interviews. Results. Thirty-eight of the 44 participants (86.4%) reported some type of changes associated with the burn injury, the treatment, or both, regarding the following aspects: work, leisure, relationships, religious ties, educational activities and habits (smoking, using alcohol and drugs and dressing style). The data showed a statistically significant association between burns on at least one of the upper limbs (with or without hands) and changes in work. Conclusions. Some of the aspects mentioned by the participants, such as work and leisure activities, need to be further researched in order to improve our understanding of the impact that these changes causes in the person's life. [ABSTRACT FROM AUTHOR]

BACKGROUND AND PURPOSE: Falls are a major health problem in the elderly community; however, questions regarding incidence, risk factors, and provider response to falls exist. The purpose of this study was to examine the incidence of falls, associated factors, health care costs, and provider response to falls among Medicare beneficiaries. PARTICIPANTS: The participants were 12,669 respondents to the Medicare Current Beneficiaries Survey (MCBS). METHODS: Categories of number of falls (none, one, recurrent) and injury type (medically injurious versus not medically injurious) were created from the falls supplement to the MCBS. Means and proportions for the entire Medicare population were estimated using sampling weights. The association between sociodemographic variables and fall status was modeled using ordinal or binary logistic regression. Aggregate health costs by fall category were estimated from claims data. RESULTS: Population estimates of falls reported in 2002 ranged from 3.7 million (single fall) to 3.1 million (recurrent falls), with an estimated 2.2 million people having a medically injurious fall. Recurrent falls were more likely with increased age, being female, being nonwhite, reporting fair or poor health, and increased number of limitations in personal activities of daily living and instrumental activities of daily living and comorbidities. Although estimates of the actual costs of falls could not be determined, 'fallers' consistently had larger utilization costs than 'nonfallers' for the year 2002. Fewer than half (48%) of the beneficiaries reported talking to a health care provider following a fall, and 60% of those beneficiaries reported receiving fall prevention information. DISCUSSION AND CONCLUSION: Falls are common and may be associated with significant health care costs. Most importantly, health care providers may be missing many opportunities to provide fall prevention information to older people. [ABSTRACT FROM AUTHOR]

Aims and objectives. To analyse the sensitivity and specificity of clinical indicators of ineffective airway clearance in children with congenital heart disease and to identify the indicators that have high predictive power. Background. The precise establishment of nursing diagnoses has been found to be one of the factors contributing to higher quality of care and cost reduction in healthcare institutions. The use of indicators to diagnose ineffective airway clearance could improve care of children with congenital heart disease. Design. Longitudinal study. Methods. Participants consisted of 45 children, <=1 year of age, with congenital heart disease, who had not had definitive or palliative surgical correction. Six assessments were made at 2-day intervals. Each clinical indicator was defined based on previously established operational criteria. Sensitivity, specificity and positive and negative predictive values of each indicator were calculated based on a model for the longitudinal data. Results. A nursing diagnosis of ineffective airway clearance was made in 31% of patients on the first assessment, rising to 71% on the last assessment, for a 40% increase. Sensitivity was highest for Changes in Respiratory Rates/Rhythms (0·99), followed by Adventitious Breath Sounds (0·97), Sputum Production (0·85) and Restlessness (0·53). Specificity was higher for Sputum Production (0·92), followed by Restlessness (0·73), Adventitious Breath Sounds (0·70) and Changes in Respiratory Rates/Rhythms (0·17). The best positive predictive values occurred for Sputum Production (0·93) and Adventitious Breath Sounds (0·80). Conclusions. Adventitious Breath Sounds followed by Sputum Production were the indicators that had the best overall sensitivity and specificity as well as the highest positive predictive values. Relevance to clinical practice. The use of simple indicators in nursing diagnoses can improve identification of ineffective airway clearance in children with congenital heart disease, thus leading to early treatment of the problem and better care for these children. [ABSTRACT FROM AUTHOR]

Abstract Background We wished to determine if there were differences in pelvic and non-pelvic tenderness between men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) Type III and men without pelvic pain. Methods We performed the Manual Tender Point Survey (MTPS) as described by the American College of Rheumatology on 62 men with CP/CPPS Type IIIA and IIIB and 98 men without pelvic pain. We also assessed tenderness of 10 external pelvic tender points (EPTP) and of 7 internal pelvic tender points (IPTP). All study participants completed the National Institutes of Health Chronic Prostatitis Symptom Inventory (NIH CPSI). Results We found that men with CPPS were significantly more tender in the MTPS, the EPTPS and the IPTPS. CPSI scores correlated with EPTP scale but not with IPTP scale or prostate tenderness. Prostatic tenderness was present in 75% of men with CPPS and in 50% of men without CPPS. Expressed prostatic fluid leukocytosis was not associated with prostatic tenderness. Conclusion Men with CP/CPPS have more tenderness compared to men without CPPS. Tenderness in men with CPPS is distributed throughout the pelvis and not specific to the prostate.

Abstract Background We examined toe-spreading ability in subjects with chronic pelvic pain syndrome (CPPS) to test the hypothesis that subjects with CPPS could have deficiencies in lower extremity functions innervated by sacral spinal roots. Methods Seventy two subjects with CPPS and 98 volunteer controls were examined as part of a larger study on CPPS. All the subjects underwent a detailed urologic and neurological examination including a toe-spreading examination with a quantitative scoring system. We compared the groups in terms of ability of toe-spreading as either "complete" (all toes spreading) or "incomplete" (at least one interdigital space not spreading) and also by comparing the number of interdigital spaces. For CPPS subjects only, we also analyzed the variation of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scales by toe-spreading categories. Results CPPS subjects were less often able to spread all toes than subjects without CPPS (p = 0.005). None of the NIH-CPSI sub-scales (pain, urinary symptoms, and quality of life), nor the total score showed an association with toe spreading ability. Conclusion We found toe spreading to be diminished in subjects with CPPS. We hypothesize that incomplete toe spreading in subjects with CPPS may be related to subtle deficits involving the most caudal part of the spinal segments.

We examined the contribution of Antonovsky's sense of coherence in explaining the variance of quality of life (QOL) in 84 patients 1-2 years following coronary artery bypass graft surgery. The hypothesis was: after controlling for variables related to poor health vulnerability, perceived support, self-esteem, and chronic illness trajectory instability and work, the addition of sense of coherence will significantly add to the explained variance of quality of life. The first two variables explained 49% of the variance of the QOL scale. Adding perceived social support, self-esteem and sense of coherence increased explained variance to 64%, 69%, and 75%, respectively. These findings supported our hypothesis. Copyright 2002 Elsevier Science Ltd. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Burns Specific Health Scale-Revised (BSHS-R) is of easy application, can be self-administered, and it is considered a good scale to evaluate various important life aspects of burn victims. OBJECTIVES: To translate and culturally adapt the BSHS-R into the Brazilian-Portuguese language and to evaluate the internal consistency and convergent validity of the translated BSHS-R. METHODS: The cultural adaptation of the BSHS-R included translation and back-translation, discussions with professionals and patients to ensure conceptual equivalence, semantic evaluation, and pre-test of the instrument. The Final Brazilian-Portuguese Version (FBPV) of the BSHS-R was tested on a group of 115 burn patients for internal consistency and validity of construct (using the Rosenberg Self-Esteem Scale (RSES) and the Beck Depression Inventory (BDI)). RESULTS: All values of Cronbach's alpha were greater than .8, demonstrating that the internal consistency of the FBPV was very high. Self-esteem was highly correlated with affect and body image (r=.59, p<.001), and with interpersonal relationships (r=.51, p<.001). Correlations between the domains of the FBPV and the BDI were all negative but larger in magnitude than the correlations with RSES. Depression was highly correlated with affect and body image (r=-.77, p<.001), and with interpersonal relationships (r=-.67, p<.001). CONCLUSIONS: The results showed that the adapted version of the BSHS-R into Brazilian-Portuguese fulfills the validity and reliability criteria required from an instrument of health status assessment for burn patients. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, there was a shortage of filtering facepiece respirators (FFR), leading to prolonged use and reuse of FFRs., Methods: FFRs were collected in 3 hospitals after extended use (up to 15 or 30days). We assessed the physical characteristics and filtration levels of worn FFRs, before sterilization. Respirators that achieved at least 94% filtration of aerosol particles, nasal clip still attached, had no tears, had preserved elastic bands, and had no dirt were randomized to receive or not receive cleaning before being submitted to hydrogen peroxide plasma gas sterilization., Results: A total of 1,055 FFRs were collected. Over 85% of them exhibited secured nose clips, preserved strap elasticity, and no tears. However, more than 78% of samples contained dirt, leaving only 101 (19.6%) eligible to undergo sterilization. After sterilization, none of the FFRs in either group achieved minimum filtration, although 72% without cleaning and 80% with cleaning had filtration between 90.0% and 93.9%., Discussion: A large proportion of FFRs were ineligible for sterilization due to factors unrelated to health care (eg, dirt from makeup)., Conclusions: Prolonged reuse of FFRs significantly reduced aerosol filtration efficiency. Eligible FFRs did not maintain 94% filtration after sterilization with or without cleaning., (Copyright © 2024 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Head and neck cancer patients frequently develop radiation dermatitis (RD) during radiotherapy. We compared liposomal gel with and without chamomile extract for the prevention and management of RD in head and neck cancer patients undergoing radiotherapy., Materials and Methods: Sixty participants undergoing radiotherapy for the first time for head and neck cancer were recruited in a double-blind randomized clinical trial. Primary outcomes were the occurrence of dry desquamation and the cumulative dose of ionizing radiation at the first occurrence of dry desquamation. Secondary outcomes were the occurrence of erythema, moist desquamation, global RD, and participant self-reported symptoms., Results: Dry desquamation occurred in 76.9 % (95 % CI: 57.9, 89.0) of participants in the chamomile liposomal gel group and in 88.9 % (95 % CI: 71.9, 96.1) in the liposomal gel group (p = 0.43). The median cumulative dose of ionizing radiation when dry desquamation occurred was 48.0 Gy in the chamomile liposomal gel group and 40.0 Gy in the liposomal gel group. Fewer symptoms were reported in the chamomile liposomal gel group., Conclusion: No statistically significant differences in outcomes were found between the two groups, though the chamomile liposomal gel group presented with lower grades of RD than the liposomal gel group. In addition, when compared to the literature on other topical interventions to manage RD, our results show that chamomile liposomal gel has potential for better management and prevention of RD in this population, which should be further tested. This study provides crucial information to design future studies. Clinical Trials Registration (REBEC): RBR-92cts3., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Purpose: To compare a liposomal gel with and without chamomile extract for the prevention of radiation dermatitis in breast cancer patients undergoing radiotherapy., Methods: This study was a double-blind randomized clinical trial. A total of 100 participants undergoing radiotherapy for breast cancer were recruited. The primary outcome was the occurrence of dry desquamation. Cumulative dose of ionizing radiation at the first occurrence of dry desquamation, occurrence of erythema, moist desquamation, global radiation dermatitis, and any signs and symptoms self-reported by participants were secondary outcomes., Results: Dry desquamation occurred in 6.0% of the participants using chamomile liposomal gel and 12.2% of those using liposomal gel (p = 0.32). The mean cumulative dose of ionizing radiation for the first occurrence of dry desquamation was 45.1 Gy in the chamomile liposomal gel group and 43.7 Gy in the liposomal gel group. There were no differences between the two gels in the occurrence of erythema, dry desquamation, moist desquamation, and radiation dermatitis compared to liposomal gel. There was a lower proportion of reported symptoms in the chamomile liposomal gel group compared to liposomal gel group in the first 3 weeks of radiation, especially for itching (p = 0.05)., Conclusion: No statistically significant differences between the two gels were found in radiation dermatitis occurrence and dose at first occurrence. Comparing to the literature, it seems that both interventions may be effective, which might explain the lack of statistical difference between the groups., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Chronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP., Methods: This is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported., Results: Medium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d =  - .49)., Conclusions: The findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare., Trial Registration: Clinicaltrials.gov, NCT03687762., (© 2024. The Author(s).)

Background and Purpose: The Langer Mindfulness Scale (LMS) is distinguished from other mindfulness scales by its dimensions, which are closely related to the awareness and experience of novelty, and by being a scale derived from a cognitive perspective of information processing. There are no mindfulness instruments of this type available in Brazil. Therefore, this study aimed to carry out a translation and cultural adaptation of the LMS into Brazilian Portuguese and to validate and assess the internal consistency and convergent construct validity of the translated instrument. Methods: The study had two distinct stages: (a) translation and cultural adaptation of the LMS into Brazilian Portuguese and (b) validation of the adapted instrument using a sample of 543 participants. Results: The Brazilian version of the LMS demonstrated acceptable internal consistency, with confirmatory factor analysis supporting the original four-factor model. Correlations between LMS, and the Five Facets of Mindfulness Questionnaire and the Mindfulness Attention Awareness Scale were statistically significant and in the expected directions. Conclusions: Our findings suggest that the Brazilian version of LMS, with its four dimensions, presents acceptable psychometric properties and seems to be a reliable and valid instrument for assessing the state of mindfulness in a Brazilian cultural context., (© 2023 Springer Publishing Company, LLC.)

Various assessment instruments have been proposed to document and evaluate radiation dermatitis. In this systematic review, we identified nineteen instruments or scales for the evaluation of radiation dermatitis and performed a critical review of the signs and symptoms included in each of them. Of those scales, only two have been validated. There is a need to revise the currently used instruments so to improve their capability to measure all relevant aspects of radiation dermatitis and their severity. In addition, it would be important to add the patients' view of their conditions and how they affect their lives. Finally, in order to be useful in clinical and research settings, instruments for evaluation of radiation dermatitis should be submitted to the validation process that is currently prescribed in the field of outcome measures development., Competing Interests: Declaration of Competing Interest On behalf of the other authors of this publication, I assure that all the authors of the. Present article do not have any conflict of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Different psychological chronic pain treatments benefit some individuals more than others. Understanding the factors that are associated with treatment response-especially when those factors differ between treatments-may inform more effective patient-treatment matching. This study aimed to identify variables that moderate treatment response to 4 psychological pain interventions in a sample of adults with low back pain or chronic pain associated with multiple sclerosis, spinal cord injury, acquired amputation, or muscular dystrophy (N = 173). The current study presents the results from secondary exploratory analyses using data from a randomized controlled clinical trial which compared the effects of 4 sessions of cognitive therapy (CT), hypnosis focused on pain reduction (HYP), hypnosis focused on changing pain-related cognitions and beliefs (HYP-CT), and a pain education control condition (ED). The analyses tested the effects of 7 potential treatment moderators. Measures of primary (pain intensity) and secondary (pain interference, depression severity) outcome domains were administered before and after the pain treatments, and potential moderators (catastrophizing, hypnotizability, and electroencephalogram (EEG)-assessed oscillation power across five bandwidths) were assessed at pre-treatment. Moderator effects were tested fitting regression analyses to pre- to post-treatment changes in the three outcome variables. The study findings, while preliminary, support the premise that pre-treatment measures of hypnotizability and EEG brain activity predict who is more (or less) likely to respond to different psychological pain treatments. If additional research replicates the findings, it may be possible to better match patients to their more individually suitable treatment, ultimately improving pain treatment outcomes. PERSPECTIVE: Pre-treatment measures of hypnotizability and EEG-assessed brain activity predicted who was more (or less) likely to respond to different psychological pain treatments. If these findings are replicated in future studies, they could inform the development of patient-treatment matching algorithms., (Copyright © 2023 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Behavioral health challenges are more prevalent in incarcerated youth than in the general youth population. Questions remain regarding whether physical activity programs can reduce behavioral health challenges in incarcerated youth. Data were available for 1,285 youths incarcerated between January 2017 and December 2018. The structured exercise program was implemented in January 2018. Primary outcomes were numbers of use of force (UoF) and of program modifications (PMs) indicative of delinquent behavior in pre- and post-exercise implementation periods. Rates per 1,000 person-days for UoF (10.0 in 2017 vs. 7.4 in 2018) and for PMs (36.7 vs. 22.9) were statistically different. For youths incarcerated both years, rates per 1,000 person-days for UoF (12.3 vs. 7.9), and for PMs (43.3 vs. 23.5) were statistically different. There was a reduction in behavior modifications in incarcerated youths after implementing the exercise program, but further studies are needed to confirm these results.

Background: A challenge often faced by people with lower extremity amputation is management of prosthetic socket fit due to changes in fluid volume within their residual limb. Prior research suggests that intermittently doffing the prosthetic socket may help stabilize daily residual limb fluid volume., Methods: To assess the effects of partial doff duration on residual limb fluid volume retention, participants with transtibial amputation were tested by walking on a treadmill in a controlled, laboratory setting under three conditions. An automated system to release the locking pin and enlarge the socket was used to produce the partial doffing. Percent limb fluid volume changes after partial doffing for 4 min (Short Rest) and for 10 min (Long Rest) were compared with no partial doffing (No Release). Limb fluid volume was monitored using bioimpedance analysis., Findings: Mean percent fluid volume changes in the posterior region were  -1.2% for No Release, 2.7% for Short Rest, and 1.0% for Long Rest. Short and Long Rests had larger increases than No Release (P = 0.005 and 0.03, respectively); Short and Long Rests were not statistically different (P = 0.10). Eight of the thirteen participants experienced a higher percent fluid volume gain for both release protocols while four experienced a higher percent fluid volume gain for only one release protocol., Interpretation: A partial doff duration as short as 4 min may be an effective strategy to stabilize limb fluid volume in prosthesis users with transtibial amputation. Trials in at-home settings should be pursued., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

We report the successful closure of Phase I clinical trials, comprising Phases Ia and Ib, of the vaccine candidate against human schistosomiasis: the Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE). Shown here are the results of Phase Ib, an open, non-placebo-controlled, standardized-dose immunization trial involving 10 healthy 18-49-year-old women. Fifty micrograms of the Sm14 protein plus 10 µg GLA-SE per dose was given intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant female rabbits, we did not find any toxicological features in either the offspring or mothers, and the vaccine induced adaptive immunity in the animals. In women, no adverse events were observed, and vaccination induced high titers of anti-Sm14 serum IgG antibody production. Vaccination also elicited robust cytokine responses, with increased TNFα, IFNγ, and IL-2 profiles in all vaccinees on days 90 and 120. The completion of Phase I clinical trials, which were performed to the highest standards set by Good Clinical Research Practice (GCP) standards, and preclinical data in pregnant rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.

Abstract: Effective, rigorously evaluated nonpharmacological treatments for chronic pain are needed. This study compared the effectiveness of training in hypnosis (HYP) and mindfulness meditation (MM) with an active education control (ED). Veterans (N = 328) were randomly assigned to 8 manualized, group-based, in-person sessions of HYP (n = 110), MM (n = 108), or ED (n = 110). Primary (average pain intensity [API]) and secondary outcomes were assessed at pretreatment, posttreatment, and 3 and 6 months posttreatment. Treatment effects were evaluated using linear regression, a generalized estimating equation approach, or a Fisher exact test, depending on the variable. There were no significant omnibus between-group differences in pretreatment to posttreatment change in API; however, pretreatment to posttreatment improvements in API and several secondary variables were seen for participants in all 3 conditions. Participation in MM resulted in greater decreases in API and pain interference at 6 months posttreatment relative to ED. Participation in HYP resulted in greater decreases in API, pain interference, and depressive symptoms at 3 and 6 months posttreatment compared with ED. No significant differences on outcomes between HYP and MM were detected at any time point. This study suggests that all 3 interventions provide posttreatment benefits on a range of outcomes, but the benefits of HYP and MM continue beyond the end of treatment, while the improvements associated with ED dissipate over time. Future research is needed to determine whether the between-group differences that emerged posttreatment are reliable, whether there are benefits of combining treatments, and to explore moderating and mediating factors., (Copyright © 2022 International Association for the Study of Pain.)

Background: Educational programs designed for specific populations to improve regular physical activity need to be tested., Objectives: To evaluate the effectiveness of an educational program, when compared to usual care, on improving physical activity 5 to 7 months after hospital discharge in adult patients undergoing their first percutaneous coronary intervention., Methods: Randomized controlled trial with two groups: usual care (n = 56) and educational program (n = 53) interventions. Data on sociodemographic and clinical characteristics were collected and the Baecke-Habitual Physical Activity Questionnaire, Self-efficacy Scale for Physical Activity, and Hospital Anxiety and Depression Scale were administered at baseline and follow-up. Participants in the educational program received an intervention based on Social Cognitive Theory, focused on physical activity, followed by three telephone calls. The usual care group received the hospital routine information. Unadjusted and adjusted differences between the two groups in mean score changes (with 95% confidence intervals [CI]) were calculated for all outcomes., Results: At follow-up, the educational program group showed higher mean ± standard deviation scores than the usual care group for practice of physical activity (7.94 ± 1.84 vs. 6.90 ± 1.89) and for self-efficacy (3.98 ± 3.75 vs. 2.52 ± 3.12). Adjusting for baseline outcome, the difference in mean change between groups was 0.89 (95% CI: 0.32, 1.46) for physical activity and 2.30 (95% CI: 1.12, 3.49) for self-efficacy. There were no statistical differences between groups in symptoms of anxiety and depression., Conclusion: The educational program may be an effective intervention in increasing habitual physical activity and self-efficacy for physical activity in individuals with coronary artery disease., Competing Interests: Conflicts of Interest All authors declare that they have no conflict of interest derived from the outcomes of this study., (Copyright © 2022 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To examine individual- and environmental-level factors associated with perceived participation performance and satisfaction in people with chronic stroke., Design: Cross-sectional study using secondary data analysis of baseline data from a randomized controlled trial., Setting: Community-based setting., Participants: Community-dwelling adults with mild to moderate stroke (N=113; mean age=57 years; 58 males)., Interventions: Not applicable., Main Outcome Measures: Main outcomes were measured with the Reintegration to Normal Living Index (perceived participation performance) and Patient-Reported Outcome Measure Information System satisfaction with participation in social roles (perceived participation satisfaction). Other variables collected included personal (eg, age, perceived recovery), health-related (eg, time since stroke, number of comorbidities), body function-related (eg, Stroke Impact Scale, Center for Epidemiologic Studies Depression Scale), and environmental (eg, World Health Organization Quality of Life Short Form Environmental subscale) data., Results: Depression, fatigue, mobility, and environmental support showed moderate to strong, statistically significant associations with participation performance and satisfaction in people with stroke. Perceived recovery was moderately associated with participation performance but not with participation satisfaction., Conclusions: Returning to participation is a complex process after stroke. Results suggest that various personal, body function-related, and environmental factors are associated with participation performance and satisfaction., (© 2022 The Authors.)

Introduction: Physical activity is important to prevent and manage multiple chronic medical conditions. The objective of this study was to describe the implementation of a physical activity vital sign (PAVS) in a primary care setting and examine the association between physical activity with demographic characteristics and chronic disease burden., Methods: We extracted data from the electronic medical records of patients who had visits from July 2018 through January 2020 in a primary care clinic in which PAVS was implemented as part of the intake process. Data collected included self-reported physical activity, age, sex, body mass index, race, ethnicity, and a modified Charlson Comorbidity Index score indicating chronic disease burden. We classified PAVS into 3 categories of time spent in moderate to strenuous intensity physical activity: consistently inactive (0 min/wk), inconsistently active (<150 min/wk), and consistently active (≥150 min/wk). We used χ 2 tests of independence to test for association between PAVS categories and all other variables., Results: During the study period, 13,704 visits, corresponding to 8,741 unique adult patients, had PAVS recorded. Overall, 18.1% of patients reported being consistently inactive, 48.3% inconsistently active, and 33.7% consistently active. All assessed demographic and clinical covariates were associated with PAVS classification (all P < .001). Larger percentages of consistent inactivity were reported for female, older, and underweight or obese patients. Larger percentages of consistent activity were reported for male, younger, and normal weight or overweight patients., Conclusion: Using PAVS as a screening tool in primary care enables physicians to understand the physical activity status of their patients and can be useful in identifying inactive patients who may benefit from physical activity counseling.

The purpose of this research was to pursue an innovative cyclic panel-pull strategy during ambulation to minimize limb fluid volume loss in transtibial prosthesis users. Participants' traditional socket shapes were duplicated, and test sockets prepared with three adjustable motor-driven panels that were controlled by a microprocessor. After donning the prosthesis, participants' liners were fastened to the panels. During a 40 min test session, participants conducted three cycles of sitting (5 min) and walking (8 min). During the 5th and 6th min of each cycle of walking, the panels were cyclically pulled outward in late stance phase, decreasing pressure on the residual limb. Panels were returned to their original position in swing phase. Eight of twelve participants gained more fluid volume while walking when panel-pull was added than when it was removed. When the liner was uncoupled from the panels and panel-pull was executed, eight of twelve participants gained less fluid volume compared to when the liner was fastened to the panels. Panel-pull may facilitate limb fluid volume retention in transtibial prosthesis users. Efforts to simplify the design so that it can be implemented in long-term testing during at-home use should be considered., (Copyright © 2022 IPEM. Published by Elsevier Ltd. All rights reserved.)

Introduction: A challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking., Methods: Adjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume., Results: In six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator's range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system., Conclusions: Stable operation of the control system suggests that the auto-adjusting socket is ready for testing in users' at-home settings., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

The major aim of this randomized, placebo-controlled, triple-blind clinical trial was to evaluate the efficacy of cinnamon as an adjuvant treatment in reducing glycemic levels in people with type 2 diabetes, compared to a placebo. The study was conducted between August and December 2019, with 160 people with type 2 diabetes, in five Primary Health Units, in Parnaíba, Brazil. Inclusion criteria were: persons of both genders using oral antidiabetic agents, with glycated hemoglobin ≥ 6.0%, and between 18 and 80 years of age. The primary outcome was change in glycated hemoglobin levels after 90 days of intervention. Other biomarkers evaluated were fasting blood glucose, insulin level, and HOMA-IR index. Participants were divided equally into two groups of 80 individuals each, and were given 3 g capsules of either cinnamon or placebo to be taken in combination with their usual oral antidiabetic agents. After 90 days, participants in the cinnamon group had statistically significant reductions of 0.2% of glycated hemoglobin and 0.55 mmol/L of fasting venous glucose, when compared with the placebo group. Cinnamon reduced the glycemic measures of persons with type 2 diabetes, albeit with modest reductions. TRIAL: RBR-2KKB6D.

Objectives: To evaluate the effect of reinforcing an educational programme through telephone follow-up on health-related quality of life and anxiety and depression symptoms in individuals starting warfarin therapy., Background: Educational interventions have improved quality of life in individuals using warfarin. Few studies have examined the addition of telephone follow-up to enhance educational interventions., Design: Randomised controlled trial in outpatient setting., Methods: Hospitalised adults starting warfarin therapy who agreed to participate received an educational programme about the warfarin treatment. At discharge, they were randomised to receive either five telephone follow-up calls (intervention) or no telephone calls (controls). Both groups were evaluated for health-related quality of life (using Duke Anticoagulation Satisfaction Scale) and symptoms of anxiety and depression (using Hospital Anxiety and Depression Scale) at three and six months post-discharge. Groups were compared at each time by independent-samples t test, and over time by repeated-measures analysis of variance, with time (three and six months), groups (intervention and control) and an interaction between time and group as factors. Level of significance was set at 0.05. The Consolidated Standards of Reporting Trials was used for reporting., Results: Fifty-two individuals (26 per group) completed the study. There were no statistical differences between groups in health-related quality of life, anxiety and depression symptoms, at both times post-discharge. Participants who received follow-up telephone calls reported better positive psychological impact (a subscale of quality of life) than controls., Conclusions: Reinforcing an educational programme with telephone follow-ups did not have an overall effect on health-related quality of life of individuals using warfarin but promoted positive psychological impact., Relevance to Clinical Practice: The low cost of reinforcing educational programmes with telephone calls and the improvement in positive psychological aspects indicate that this type of intervention is still a promising intervention that could be further investigated and improved., (© 2021 John Wiley & Sons Ltd.)

Abstract: The current study used data from a clinical trial to identify variables that are associated with and/or mediate the beneficial effects of 4 psychological chronic pain treatments: one teaching patients self-hypnosis to reduce pain intensity (HYP), one teaching self-hypnosis to change thoughts about pain (hypnotic cognitive therapy [HYP-CT]), one teaching cognitive restructuring skills to change thoughts about pain (cognitive therapy [CT]), and one providing education about pain (ED; included as an active control condition). Of 17 possible mechanism variables examined, and with alpha not corrected for multiple comparisons, significant between-group differences were observed for 3. Two of these (changes in beliefs about control over pain and number of days of skill practice) were supported as mediators of the beneficial effects of HYP, CT, or HYP-CT, relative to ED. Six mechanism variables evidenced significant pretreatment to post-treatment changes in the sample as a whole, without showing significant between-group differences. Pretreatment to post-treatment changes in all 6 were associated with improvements in pain interference, pain intensity, or both. In addition, participant ratings of therapeutic alliance at post-treatment were associated significantly with improvements in both pain intensity and pain interference in the sample as a whole. Thus, of the 17 possible mediators examined, there were relatively few that served as mediators for the beneficial effects of specific treatments; a larger number of variables predicted treatment outcome overall. The extent to which these variables are treatment mediators (ie, are responsible for, rather than merely associated with, treatment-related improvements) will require further research., (Copyright © 2021 International Association for the Study of Pain.)

Objectives: to identify the occurrence of oncology teaching in undergraduate nursing curricula., Methods: descriptive study, which data was obtained from curriculum and from Pedagogical Course Projects available on the websites from Brazilian public institutions, between June and July 2020., Results: 143 undergraduate nursing courses were identified. From them, 132 nursing courses (corresponding to 89 education institutions) had available the curriculum and/or Pedagogical Course Projects. Only 7 (5.3%) of them had oncology as a mandatory subject, 4 of them in the Midwest Region. Only 35 (26.5%) had elective subject in Oncology, most of them in the Northeast (45.7%)., Conclusions: on third of nursing courses at public institutions has Oncology subject in the curriculum, which is few considering the high incidence and mortality from cancer in the country. The findings contribute for discussions, in curricular accommodation, on the relevance of oncology teaching in nursing curricula.

Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.govNCT03422276), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03422276., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To estimate the incidence and distribution of the degree of radiodermatitis in cancer patients submitted to radiotherapy in the regions of head and neck, breast, and pelvis., Method: Prospective, longitudinal, quantitative study conducted from March 15, 2016 to May 4, 2017 with patients observed for five weeks of treatment. The primary outcome was the proportion of grade 1 or higher radiodermatitis each week. The degree of radiodermatitis and mean time of occurrence for each patient were secondary outcomes., Results: This study included 112 patients. The incidence of radiodermatitis was 100% among those whose head and neck region was irradiated, followed by 98% for breast and 48% for the pelvic region. The degree of radiodermatitis varied with the irradiated site; the worst degrees were found in the head and neck region, followed by the breast. In the three groups, the mean time of the first occurrence of radiodermatitis was approximately eleven days., Conclusion: The incidence of radiodermatitis in the studied groups was high, which reinforces the need to perform the same evaluation nationwide. This would support creating and standardizing protocols and recommendations for a proper management of radiodermatitis, specially concerning its prevention.

Background/objective: After wearing powdered gloves, healthcare workers (HCW) are supposed to wash their hands instead of using alcohol-based hand-rub (ABHR). Washing hands takes longer than using ABHR, and the use of powdered gloves may be an obstacle to hand-hygiene compliance. This study aimed to evaluate the impact of replacing powdered gloves with powder-free gloves on hand-hygiene compliance among HCW of an intensive care unit (ICU)., Methods: A quasi-experimental study was conducted in a general ICU of a tertiary care university hospital in Brazil. From June 1st to July 15th, 2017, all HCW were provided with powdered latex gloves only for all clinical procedures. From July 15th to August 31st, 2017, HCW were provided with nitrile powder-free gloves only. Hand-hygiene compliance was assessed through direct observation, and evaluated according to the World Health Organization Hand Hygiene guidelines. We calculated that a sample size of 544 hand hygiene opportunities needed to be observed per period. Data analysis were performed using the STATA SE® version 14, and we compared the individual's percentage of compliance using the t test for paired data before and after the intervention., Results: Overall, 40 HCW were assessed before and after the introduction of nitrile powder-free gloves, with 1114 and 1139 observations of hand hygiene opportunities, respectively. The proportion of compliance with hand hygiene was 55% (95% confidence interval [CI] 51-59%) using powdered latex gloves and 60% (95% CI 57-63%) using powder-free gloves. The difference in proportions between the two types of gloves was 5.1% (95% CI 2.5-7.6%, p < 0.001)., Conclusion: Our data indicate that replacing powdered gloves with powder-free gloves positively influenced hand-hygiene compliance by HCW in an ICU setting.

Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of 4 treatment sessions each of 4 nonpharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive 4 sessions of 1 of the 4 treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pretreatment, posttreatment, and 3-, 6-, and 12-month follow-up. Treatment effects were evaluated using analysis of variance, a generalized estimating equation approach, or a Fisher exact test, depending on the outcome domain examined. All 4 treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months posttreatment. Pretreatment to posttreatment improvements were observed across the 4 treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pretreatment levels at 12-month follow-up. No significant between-group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the 2 significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine whether the significant differences that emerged are reliable.

This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims and Objectives: To compare mentholated popsicle with usual care (absolute fasting) in the change of thirst intensity and discomfort of patients in the preoperative fasting., Background: Thirst is defined as the desire to drink water, and it is considered to be a multifactorial symptom. In the preoperative fasting, the patient may experience intense thirst, often for a long time, that can lead to feelings of suffocation, desperation, fear and anxiety., Design: A randomised controlled trial., Methods: Forty patients, aged between 18-60 years, were randomised to mentholated popsicle group or absolute fasting group (twenty in each). The primary outcomes were thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale), both measured twice (baseline and after 20 min of intervention). The CONSORT checklist was used to report this study., Results: Mean age was similar in both groups (38 years in the mentholated popsicle group and 39 in the absolute fasting group). At baseline, the mentholated popsicle group had higher median for the scales of intensity (6.5) and discomfort (7.5) from thirst than the absolute fasting group (5.0 and 5.0, respectively). At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively)., Conclusions: The use of mentholated popsicle decreased the intensity and discomfort from thirst, and it is a viable strategy for the management of thirst in the preoperative fasting., Relevance to Clinical Practice: In the preoperative fasting, making mentholated popsicles available to patients is an easy strategy to manage thirst, which might lead to better care., (© 2019 John Wiley & Sons Ltd.)

Background: Conservative treatment for carpal tunnel syndrome (CTS) often includes wrist orthosis. However, there is no consensus on whether commercial or custom-made wrist orthosis is better for the treatment., Purpose: To assess feasibility of a study comparing nocturnal use of commercial versus custom-made wrist orthosis in the treatment of mild/moderate CTS and estimate their potential effects on function and symptoms., Study Design: Randomized clinical trial., Methods: Twenty-four individuals with mild/moderate CTS were randomized to wear either a commercial orthosis (n = 12) or a custom-made orthosis (n = 12). Participants used the assigned orthosis at night for 45 days and performed gliding exercises at home/work. We collected data on access to eligible population and feasibility of protocol. Data on use of orthosis, performance of exercises, and symptoms were collected through a dairy filled by the participant. Outcomes were pain (using Numeric Pain Rating Scale), symptom severity and functional status (using Boston Questionnaire), pinch strength (by dynamometry), and electromyographic activity of forearm muscles (sampled during a reach-to-grasp task). Outcomes were measured before and after the intervention., Results: There were no loses to follow-up in either intervention group. After treatment, we found increased tripod pinch strength and better symptoms and function in both orthosis groups, with better outcomes for the custom-made orthosis, although the differences were not statistically significant., Conclusions: The preliminary results showed a potential for better outcomes from the custom-made orthosis. We established that a larger study would be feasible and could be designed and conducted based on the estimates provided by this study., Trial Registration: Brazilian Registry of Clinical Trials (ReBEC) - registration number: RBR-74rqnz., Competing Interests: Declarations of competing interest No conflicts of interest have been reported by the authors of this study., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.