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The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients. In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales. The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals' SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group's outcomes at each assessment point. Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals' sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Background: Intensive care unit (ICU) patients often experience significant physiological stress. This study evaluated the effect of a defined family visitation protocol on physiological responses in the ICU. Methods: A randomized, block-randomized clinical trial was conducted on 78 ICU patients at Imam Reza Hospital between February 8, 2017, and August 8, 2017. The intervention group received protocol-based visits, and the control group continued with standard visitation. Block randomization was utilized for group assignments. The primary outcome was the measurement of physiological signs using designated monitoring devices. Data were analyzed using SPSS version 22, employing independent t-tests, Mann-Whitney U test, repeated measures analysis, and Friedman's test. Results: The results showed no significant differences in systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and arterial blood oxygen levels between the two groups. However, heart rate in the intervention group was significantly lower in three stages before, during, and after the meaningful visiting (P = 0.008). Conclusion: Protocol-based scheduled family visits in the ICU may reduce physiological stress, as evidenced by a decrease in patients' heart rate. Implementing tailored visitation protocols sensitive to patient preferences and clinical contexts is advisable, suggesting the integration of family visits into standard care practices for enhanced patient outcomes. Trial Registration: IRCT20161229031654N2; 25/01/2018; Iranian Registry of Clinical Trials (https://en.irct.ir). [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the efficacy of dietary modifications based on complementary and alternative Iranian medicine (CAIM) in patients with secondary-progressive multiple sclerosis (SPMS). Design: In this randomized controlled trial, 70 SPMS patients were randomized to receive either a moderate-nature diet based on Persian medicine (as intervention) or usual diet plus health-related diet recommendations (as control) for 2 months. Serum high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), Expanded Disability Status Scale (EDSS), Modified Fatigue Impact Scale (MFIS), State-Trait Anxiety Inventory (STAI), Global Pain Scale (GPS), Gastrointestinal Symptom Rating Scale (GSRS), anthropometric measurements, and quality of life (QOL) were assessed at baseline and end of trial. Analysis of covariance was performed, and the results were adjusted for potential confounders using SPSS v.14. Results: All participants completed the study for 2 months. There were significant improvements across the mean changes of hs-CRP (−0.1 ± 0.2 mg/L for intervention vs. −0.01 ± 0.13 mg/L for control; padjusted = 0.012), MFIS (−11.0 ± 11.8 vs. −0.7 ± 9.9; padjusted <0.001), GSRS (−19.9 ± 16.3 to 1.2 ± 17.5; padjusted <0.001), GPS (padjusted = 0.032), and QOL (padjusted <0.05). No significant difference was observed across the ESR, EDSS, STAI, and anthropometric measurements. Conclusion: Dietary modifications based on CAIM may improve inflammation and clinical manifestations in SPMS patients. Nonetheless, further trials are required to confirm these findings. Clinical Trial Registration: IRCT20181113041641N2. [ABSTRACT FROM AUTHOR]

Aims Burns and wounds caused by it are a global injury. Finding natural ingredients to accelerate wound healing in patients with fewer side effects could be valuable. This study aimed to determine the effect of oral Centella asiatica extract on the healing of pain and wound of burn in patients. Materials & Methods This study is a clinical trial in which 76 patients hospitalized in the burn department were randomly divided into two intervention (n=38) and control (n=38) groups. The intervention group, in addition to the usual antibiotic treatments, received capsules containing 200mg of Centella asiatica twice daily, and the control group received capsules containing 200mg of starch twice daily. Data collection tools were Bates-Jensen Wound Assessment tool and Visual Analog Scale. Patients' pain and wound healing status were examined at different time of the study. Findings The mean burn pain score showed a significant improvement in the intervention group compared to the control group (p<0.001). The average wound healing score did not show significant improvement in the intervention group compared to the control group (p=0.561). However, size (p=0.023), the degree of destruction of the underlying tissues (p=0.032), the amount of necrotic tissue (p=0.015), and the amount of granulation tissue (p=0.001) improved significantly in the intervention group. In addition, the peripheral tissue edema in the control group decrease significantly compared to the intervention group (p=0.008). Conclusion Oral extract of Centella asiatica reduces pain in burn patients. However, it does not affect wound healing, although it improves some wound healing indicators. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy-induced nausea and vomiting (CINV) is considered as the most common complications of chemotherapy which has a detrimental influence on the quality of life of patients with cancer. We assessed the efficacy of Apple (Malus domestica) syrup for reducing CINV. Materials and Methods: This study was a randomized, double-blind, placebo-controlled trial carried out in a Hematooncology Clinic affiliated to Mazandaran University of Medical Sciences, Sari, Iran (from October 2017 to August 2018). Subjects were randomly allocated to receive apple syrup or placebo along with their previous antiemetic treatment and chemotherapy regimen, three times a day. Thirty-four patients received apple syrup (n = 16) or placebo (n = 18). Statistical analysis was conducted using SPSS software Version 21® (SPSS Inc., Chicago, IL, USA). A P < 0.05 indicated statistical significance. Results: Both acute and delayed nausea grades were significantly lower in M. domestica syrup in comparison to placebo syrup (P = 0.001 and 0.001, respectively). The duration of nausea (P = 0.04) was lower in intervention group compared to placebo group. Conclusion: These findings demonstrated that M. domestica syrup can reduce the severity and duration of nausea in cancer patients who received chemotherapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group (n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group (n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability. [ABSTRACT FROM AUTHOR]

The efficacy of β -cryptoxanthin (BCX), a high-protein diet (HPD), or both in reducing oxidative stress and inflammation in nonalcoholic fatty liver disease (NAFLD) has never been examined within a randomized controlled trial (RCT). Thus, we aimed to assess the efficacy of an energy-restricted HPD supplemented with BCX in alleviating these conditions in NAFLD in an RCT design. We hypothesized that this combination may improve oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet. Ninety-two ultrasonographically confirmed overweight/obese adult NAFLD patients attending an outpatient clinic in Ahvaz, Iran, were recruited for this 12-week, single-center, parallel-group, double-blind RCT from 2017 to 2018. Subjects were randomized into 4 equal groups (n = 23): HPD-BCX (energy-restricted HPD + BCX), HPD (energy-restricted HPD + placebo), BCX (standard energy-restricted diet + BCX), and control (standard energy-restricted diet + placebo). Serum levels of oxidative stress– and inflammation-related markers, as primary outcome measures, were determined at baseline and at the study end point. The 1-way analysis of covariance models in the intention-to-treat population (N = 92) showed that the HPD-BCX group achieved greater 12-week reductions in malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, and total cytokeratin-18 (CK18-M65) but higher increases in total antioxidant capacity and adiponectin compared to the control group (mean differences for malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, total cytokeratin-18, total antioxidant capacity, and adiponectin were −1.9 nmol/mL, −1.0 mg/L, −2.0 ng/L, −270.9 ng/L, 2.5 U/mL, and 1.9 mg/L, respectively; all P <.001). These results show that an energy-restricted HPD supplemented with BCX more efficaciously alleviates oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet. [ABSTRACT FROM AUTHOR]

Background: Evaluation of clinical skills is critically important for nursing students. However, the quality of evaluation tools is poor. Objectives: To evaluate the effectiveness of Direct Observation of Procedural Skills (DOPS) and Mini-Clinical Evaluation Exercise (Mini-CEX) on clinical skills of nursing students. Methods: This study was conducted among 108 senior nursing students. Mini-CEX and DOPS were utilized to evaluate clinical skills in the intervention group. Results: The mean of students' scores in all of the five procedures was significantly higher in the intervention group compared to control group.. Students' scores for the procedures significantly raised through the first stage of DOPS and Mini-CEX to the third stage. Conclusions: Utilization of DOPS and Mini-CEX for evaluation of clinical skills in nursing students effectively enhance their learning ability. Implementing of such assessment methods lead to promoting clinical skills of students which eventually help them to provide high quality care for their patients. [ABSTRACT FROM AUTHOR]

Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing). Methods: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals' instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. Results: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. Conclusion: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs. [ABSTRACT FROM AUTHOR]

Purpose: Controversy exists regarding whether increasing dairy intake without energy restriction would lead to weight loss. We aimed to compare the potential weight-reducing effects of kefir drink (a probiotic dairy product) and milk in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. Methods: One hundred and forty-four subjects were assessed for eligibility in this single-center, multi-arm, parallel-group, randomized controlled trial. Of these, seventy-five eligible women aged 25-45 years were randomly assigned to three groups, labeled as control, milk, and kefir, to receive an outpatient dietary regimen for 8 weeks. Subjects in the control group received a diet providing a maintenance level of energy intake, containing 2 servings/day of low-fat dairy products, while those in the milk and kefir groups received a weight maintenance diet, containing 2 additional servings/day (a total of 4 servings/day) of dairy products from low-fat milk or commercial kefir drink, respectively. Anthropometric outcomes including weight, body mass index (BMI), and waist circumference (WC) were measured every 2 weeks. Results: Fifty-eight subjects completed the study. Using analysis of covariance models in the intention-to-treat population ( n = 75), we found that at 8 weeks, subjects in the kefir and milk groups had significantly greater reductions in weight, BMI, and WC compared to those in the control group (all p < 0.01). However, no such significant differences were found between the kefir and milk groups. Conclusions: Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. However, further studies are warranted. [ABSTRACT FROM AUTHOR]