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Supplemental Digital Content is available in the text., Background: This systematic review evaluated the effectiveness of simple psychological interventions for managing pain and fear in adults undergoing vaccination or related common needle procedures (ie, venipuncture/venous cannulation). Design/Methods: Databases were searched to identify relevant randomized and quasi-randomized controlled trials. Self-reported pain and fear were prioritized as critically important outcomes. Data were combined using standardized mean difference (SMD) or relative risk (RR) with 95% confidence intervals (CI). Results: No studies involving vaccination met inclusion criteria; evidence was drawn from 8 studies of other common needle procedures (eg, venous cannulation, venipuncture) in adults. Two trials evaluating the impact of neutral signaling of the impending procedure (eg, “ready?”) as compared with signaling of impending pain (eg, “sharp scratch”) demonstrated lower pain when signaled about the procedure (n=199): SMD=−0.97 (95% CI, −1.26, −0.68), after removal of 1 trial where self-reported pain was significantly lower than the other 2 included trials. Two trials evaluated music distraction (n=156) and demonstrated no difference in pain: SMD=0.10 (95% CI, −0.48, 0.27), or fear: SMD=−0.25 (95% CI, −0.61, 0.10). Two trials evaluated visual distraction and demonstrated no difference in pain (n=177): SMD=−0.57 (95% CI, −1.82, 0.68), or fear (n=81): SMD=−0.05 (95% CI, −0.50, 0.40). Two trials evaluating breathing interventions found less pain in intervention groups (n=138): SMD=−0.82 (95% CI, −1.21, −0.43). The quality of evidence across all trials was very low. Conclusions: There are no published studies of simple psychological interventions for vaccination pain in adults. There is some evidence of a benefit from other needle procedures for breathing strategies and neutral signaling of the start of the procedure. There is no evidence for use of music or visual distraction.

The HELPinKids&Adults knowledge synthesis for the management of vaccination-related pain and high levels of needle fear updated and expanded upon the 2010 HELPinKIDS knowledge synthesis and clinical practice guideline for pain mitigation during vaccine injections in childhood. Interventions for vaccine pain management in adults and treatment of individuals with high levels of needle fear, phobias, or both were included, thereby broadening the reach of this work. The present paper outlines the overarching limitations of this diverse evidence base and provides recommendations for future research. Consistent with the framing of clinical questions in the systematic reviews, the Participants, Intervention, Comparison, Outcome, Study design (PICOAS) framework was used to organize these predominant issues and research directions. The major limitations we identified across systematic reviews were an overall dearth of trials on vaccination, lack of methodological rigor, failure to incorporate important outcomes, poor study reporting, and various sources of heterogeneity. Future research directions in terms of conducting additional trials in the vaccination context, improving methodological quality and rigor, assessment of global acceptability and feasibility of interventions, and inclusion of outcomes that stakeholders consider to be important (eg, compliance) are recommended. Given concerns about pain and fear are known contributors to vaccine hesitancy, improving and expanding this evidence base will be integral to broader efforts to improve vaccine compliance and public health worldwide.

Supplemental Digital Content is available in the text., Background: This systematic review evaluated the effectiveness of exposure-based psychological and physical interventions for the management of high levels of needle fear and/or phobia and fainting in children and adults. Design/Methods: A systematic review identified relevant randomized and quasi-randomized controlled trials of children, adults, or both with high levels of needle fear, including phobia (if not available, then populations with other specific phobias were included). Critically important outcomes were self-reported fear specific to the feared situation and stimulus (psychological interventions) or fainting (applied muscle tension). Data were pooled using standardized mean difference (SMD) or relative risk with 95% confidence intervals. Results: The systematic review included 11 trials. In vivo exposure-based therapy for children 7 years and above showed benefit on specific fear (n=234; SMD: −1.71 [95% CI: −2.72, −0.7]). In vivo exposure-based therapy with adults reduced fear of needles posttreatment (n=20; SMD: −1.09 [−2.04, −0.14]) but not at 1-year follow-up (n=20; SMD: −0.28 [−1.16, 0.6]). Compared with single session, a benefit was observed for multiple sessions of exposure-based therapy posttreatment (n=93; SMD: −0.66 [−1.08, −0.24]) but not after 1 year (n=83; SMD: −0.37 [−0.87, 0.13]). Non in vivo e.g., imaginal exposure-based therapy in children reduced specific fear posttreatment (n=41; SMD: −0.88 [−1.7, −0.05]) and at 3 months (n=24; SMD: −0.89 [−1.73, −0.04]). Non in vivo exposure-based therapy for adults showed benefit on specific fear (n=68; SMD: −0.62 [−1.11, −0.14]) but not procedural fear (n=17; SMD: 0.18 [−0.87, 1.23]). Applied tension showed benefit on fainting posttreatment (n=20; SMD: −1.16 [−2.12, −0.19]) and after 1 year (n=20; SMD: −0.97 [−1.91, −0.03]) compared with exposure alone. Conclusions: Exposure-based psychological interventions and applied muscle tension show evidence of benefit in the reduction of fear in pediatric and adult populations.

Vaccine injections are unique in that they are regularly experienced by children who are healthy as well as those who have chronic illness, making them the most common painful medical procedure performed worldwide.1 Multipronged approaches to pain management include pharmacological, psychological, procedural, and physical strategies, all of which have been studied to reduce the pain and distress associated with vaccine injections.2–4 Of these approaches, psychological interventions hold considerable appeal to families given that they capitalize on strategies that children and parents already engage in naturally to some extent (eg, distraction), and, due to their nonpharmacological nature, are generally met with higher acceptance by parents. Many psychological interventions are simple and require minimal or no training, are able to be implemented directly by children, parents, and immunizers, and are applicable across a wide age range. Furthermore, they generally capitalize on available resources, making them easy to implement across different clinical settings.5 In a previous knowledge synthesis on this topic, support was found for several different psychological interventions for vaccination pain, including breathing exercises, child-led or nurse-led distraction, and combined cognitive-behavioral interventions (ie, strategies aimed at modifying emotions, behaviors, and cognitions).3 These interventions were subsequently incorporated into a clinical practice guideline for childhood vaccination pain management.6 Since the original guideline was developed, additional research in the area has been published. Furthermore, the previous systematic review and meta-analysis grouped together infants and children, and omitted adolescents; this led to a gap in knowledge synthesis and recommendations for each pediatric population who present unique developmental considerations.3 Given recent evidence suggesting possible differences in treatment efficacy based on intervention characteristics,5 alternative approaches to examining the literature are warranted, in particular, the type of distracter used. Our previous synthesis examined the literature according to the individual directing the intervention.3 The current systematic review and meta-analysis was therefore undertaken to provide the evidence base for an update and expansion of the original guideline in the specific area of psychological interventions for children and adolescents undergoing vaccine injections and evaluated the data according to the type of distractor used. This review reports the results for trials that evaluated the effect of any of the following psychological interventions for the management of vaccination pain and related outcomes: (1) false suggestion, (2) repeated reassurance, (3) verbal distraction, (4) video distraction, (5) music distraction, (6) breathing with toy, (7) breathing without toy, and (8) breathing intervention (cough). Separate papers explore the effectiveness of psychological interventions in young children (0 to 3 y)7 and adults,8 as well as pharmacological, physical, procedural, and process approaches for infants, children, adolescents, and adults.

Supplemental Digital Content is available in the text., Background: This systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination. Design/Methods: Databases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR). Results: Thirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD −0.85; 95% CI: −1.35, −0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, −0.35; 95% CI: −0.57, −0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD −0.48; 95% CI: −0.82, −0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD −0.67; 95% CI: −1.28, −0.07). Conclusions: Educating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.

Aim: To assess the sensitivity and specificity of automated movement recognition in predicting motor impairment in high-risk infants. Method: We searched MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, and Scopus databases and identified additional studies from the references of relevant studies. We included studies that evaluated automated movement recognition in high-risk infants to predict motor impairment, including cerebral palsy (CP) and non-CP motor impairments. Two authors independently assessed studies for inclusion, extracted data, and assessed methodological quality using the Quality Assessment of Diagnostic Accuracy Studies-2. Meta-analyses were performed using hierarchical summary receiver operating characteristic models. Results: Of 6536 articles, 13 articles assessing 59 movement variables in 1248 infants under 5months corrected age were included. Of these, 143 infants had CP. The overall sensitivity and specificity for motor impairment were 0.73 (95% confidence interval [CI] 0.68–0.77) and 0.70 (95% CI 0.65–0.75) respectively. Comparatively, clinical General Movements Assessment (GMA) was found to have sensitivity and specificity of 98% (95% CI 74–100) and 91% (95% CI 83–93) respectively. Sensor-based technologies had higher specificity (0.88, 95% CI 0.80–0.93). Interpretation: Automated movement recognition technology remains inferior to clinical GMA. The strength of this study is its meta-analysis to summarize performance, although generalizability of these results is limited by study heterogeneity.