Non-pharmacological management of infant and young child procedural pain.

BACKGROUND: Despite evidence of the long-term implications of unrelieved pain during infancy, it is evident that infant pain is still under-managed and unmanaged. Inadequately managed pain in infancy, a period of exponential development, can have implications across the lifespan. Therefore, a comprehensive and systematic review of pain management strategies is integral to appropriate infant pain management. This is an update of a previously published review update in the Cochrane Database of Systematic Reviews (2015, Issue 12) of the same title. OBJECTIVES: To assess the efficacy and adverse events of non-pharmacological interventions for infant and child (aged up to three years) acute pain, excluding kangaroo care, sucrose, breastfeeding/breast milk, and music. SEARCH METHODS: For this update, we searched CENTRAL, MEDLINE-Ovid platform, EMBASE-OVID platform, PsycINFO-OVID platform, CINAHL-EBSCO platform and trial registration websites (ClinicalTrials.gov; International Clinical Trials Registry Platform) (March 2015 to October 2020). An update search was completed in July 2022, but studies identified at this point were added to 'Awaiting classification' for a future update.  We also searched reference lists and contacted researchers via electronic list-serves.  We incorporated 76 new studies into the review.  SELECTION CRITERIA: Participants included infants from birth to three years in randomised controlled trials (RCTs) or cross-over RCTs that had a no-treatment control comparison. Studies were eligible for inclusion in the analysis if they compared a non-pharmacological pain management strategy to a no-treatment control group (15 different strategies). In addition, we also analysed studies when the unique effect of adding a non-pharmacological pain management strategy onto another pain management strategy could be assessed (i.e. additive effects on a sweet solution, non-nutritive sucking, or swaddling) (three strategies). The eligible control groups for these additive studies were sweet solution only, non-nutritive sucking only, or swaddling only, respectively. Finally, we qualitatively described six interventions that met the eligibility criteria for inclusion in the review, but not in the analysis.  DATA COLLECTION AND ANALYSIS: The outcomes assessed in the review were pain response (reactivity and regulation) and adverse events. The level of certainty in the evidence and risk of bias were based on the Cochrane risk of bias tool and the GRADE approach. We analysed the standardised mean difference (SMD) using the generic inverse variance method to determine effect sizes.  MAIN RESULTS: We included total of 138 studies (11,058 participants), which includes an additional 76 new studies for this update. Of these 138 studies, we analysed 115 (9048 participants) and described 23 (2010 participants) qualitatively. We described qualitatively studies that could not be meta-analysed due to being the only studies in their category or statistical reporting issues. We report the results of the 138 included studies here. An SMD effect size of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect. The thresholds for the I2 interpretation were established as follows: not important (0% to 40%); moderate heterogeneity (30% to 60%); substantial heterogeneity (50% to 90%); considerable heterogeneity (75% to 100%). The most commonly studied acute procedures were heel sticks (63 studies) and needlestick procedures for the purposes of vaccines/vitamins (35 studies). We judged most studies to have high risk of bias (103 out of 138), with the most common methodological concerns relating to blinding of personnel and outcome assessors. Pain responses were examined during two separate pain phases: pain reactivity (within the first 30 seconds after the acutely painful stimulus) and immediate pain regulation (after the first 30 seconds following the acutely painful stimulus). We report below the strategies with the strongest evidence base for each age group. In preterm born neonates, non-nutritive sucking may reduce pain reactivity (SMD -0.57, 95% confidence interval (CI) -1.03 to -0.11, moderate effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.61, 95% CI -0.95 to -0.27, moderate effect; I2 = 81%, considerable heterogeneity), based on very low-certainty evidence. Facilitated tucking may also reduce pain reactivity (SMD -1.01, 95% CI -1.44 to -0.58, large effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.59, 95% CI -0.92 to -0.26, moderate effect; I2 = 87%, considerable heterogeneity); however, this is also based on very low-certainty evidence. While swaddling likely does not reduce pain reactivity in preterm neonates (SMD -0.60, 95% CI -1.23 to 0.04, no effect; I2 = 91%, considerable heterogeneity), it has been shown to possibly improve immediate pain regulation (SMD -1.21, 95% CI -2.05 to -0.38, large effect; I2 = 89%, considerable heterogeneity), based on very low-certainty evidence. In full-term born neonates, non-nutritive sucking may reduce pain reactivity (SMD -1.13, 95% CI -1.57 to -0.68, large effect; I2 = 82%, considerable heterogeneity) and improve immediate pain regulation (SMD -1.49, 95% CI -2.20 to -0.78, large effect; I2 = 92%, considerable heterogeneity), based on very low-certainty evidence.  In full-term born older infants, structured parent involvement was the intervention most studied. Results showed that this intervention has little to no effect in reducing pain reactivity (SMD -0.18, 95% CI -0.40 to 0.03, no effect; I2 = 46%, moderate heterogeneity) or improving immediate pain regulation (SMD -0.09, 95% CI -0.40 to 0.21, no effect; I2 = 74%, substantial heterogeneity), based on low- to moderate-certainty evidence. Of these five interventions most studied, only two studies observed adverse events, specifically vomiting (one preterm neonate) and desaturation (one full-term neonate hospitalised in the NICU) following the non-nutritive sucking intervention. The presence of considerable heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of evidence of very low to low certainty based on GRADE judgements. AUTHORS' CONCLUSIONS: Overall, non-nutritive sucking, facilitated tucking, and swaddling may reduce pain behaviours in preterm born neonates. Non-nutritive sucking may also reduce pain behaviours in full-term neonates. No interventions based on a substantial body of evidence showed promise in reducing pain behaviours in older infants. Most analyses were based on very low- or low-certainty grades of evidence and none were based on high-certainty evidence. Therefore, the lack of confidence in the evidence would require further research before we could draw a definitive conclusion.

Psychological interventions for needle-related procedural pain and distress in children and adolescents.

BACKGROUND: This is the second update of a Cochrane Review (Issue 4, 2006). Pain and distress from needle-related procedures are common during childhood and can be reduced through use of psychological interventions (cognitive or behavioral strategies, or both). Our first review update (Issue 10, 2013) showed efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents. OBJECTIVES: To assess the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. SEARCH METHODS: We searched six electronic databases for relevant trials: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; PsycINFO; Embase; Web of Science (ISI Web of Knowledge); and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We sent requests for additional studies to pediatric pain and child health electronic listservs. We also searched registries for relevant completed trials: clinicaltrials.gov; and World Health Organization International Clinical Trials Registry Platform (www.who.int.trialsearch). We conducted searches up to September 2017 to identify records published since the last review update in 2013. SELECTION CRITERIA: We included peer-reviewed published randomized controlled trials (RCTs) with at least five participants per study arm, comparing a psychological intervention with a control or comparison group. Trials involved children aged two to 19 years undergoing any needle-related medical procedure. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and assessed risks of bias using the Cochrane 'Risk of bias' tool. We examined pain and distress assessed by child self-report, observer global report, and behavioral measurement (primary outcomes). We also examined any reported physiological outcomes and adverse events (secondary outcomes). We used meta-analysis to assess the efficacy of identified psychological interventions relative to a comparator (i.e. no treatment, other active treatment, treatment as usual, or waitlist) for each outcome separately. We used Review Manager 5 software to compute standardized mean differences (SMDs) with 95% confidence intervals (CIs), and GRADE to assess the quality of the evidence. MAIN RESULTS: We included 59 trials (20 new for this update) with 5550 participants. Needle procedures primarily included venipuncture, intravenous insertion, and vaccine injections. Studies included children aged two to 19 years, with few trials focused on adolescents. The most common psychological interventions were distraction (n = 32), combined cognitive behavioral therapy (CBT; n = 18), and hypnosis (n = 8). Preparation/information (n = 4), breathing (n = 4), suggestion (n = 3), and memory alteration (n = 1) were also included. Control groups were often 'standard care', which varied across studies. Across all studies, 'Risk of bias' scores indicated several domains at high or unclear risk, most notably allocation concealment, blinding of participants and outcome assessment, and selective reporting. We downgraded the quality of evidence largely due to serious study limitations, inconsistency, and imprecision.Very low- to low-quality evidence supported the efficacy of distraction for self-reported pain (n = 30, 2802 participants; SMD -0.56, 95% CI -0.78 to -0.33) and distress (n = 4, 426 participants; SMD -0.82, 95% CI -1.45 to -0.18), observer-reported pain (n = 11, 1512 participants; SMD -0.62, 95% CI -1.00 to -0.23) and distress (n = 5, 1067 participants; SMD -0.72, 95% CI -1.41 to -0.03), and behavioral distress (n = 7, 500 participants; SMD -0.44, 95% CI -0.84 to -0.04). Distraction was not efficacious for behavioral pain (n = 4, 309 participants; SMD -0.33, 95% CI -0.69 to 0.03). Very low-quality evidence indicated hypnosis was efficacious for reducing self-reported pain (n = 5, 176 participants; SMD -1.40, 95% CI -2.32 to -0.48) and distress (n = 5, 176 participants; SMD -2.53, 95% CI -3.93 to -1.12), and behavioral distress (n = 6, 193 participants; SMD -1.15, 95% CI -1.76 to -0.53), but not behavioral pain (n = 2, 69 participants; SMD -0.38, 95% CI -1.57 to 0.81). No studies assessed hypnosis for observer-reported pain and only one study assessed observer-reported distress. Very low- to low-quality evidence supported the efficacy of combined CBT for observer-reported pain (n = 4, 385 participants; SMD -0.52, 95% CI -0.73 to -0.30) and behavioral distress (n = 11, 1105 participants; SMD -0.40, 95% CI -0.67 to -0.14), but not self-reported pain (n = 14, 1359 participants; SMD -0.27, 95% CI -0.58 to 0.03), self-reported distress (n = 6, 234 participants; SMD -0.26, 95% CI -0.56 to 0.04), observer-reported distress (n = 6, 765 participants; SMD 0.08, 95% CI -0.34 to 0.50), or behavioral pain (n = 2, 95 participants; SMD -0.65, 95% CI -2.36 to 1.06). Very low-quality evidence showed efficacy of breathing interventions for self-reported pain (n = 4, 298 participants; SMD -1.04, 95% CI -1.86 to -0.22), but there were too few studies for meta-analysis of other outcomes. Very low-quality evidence revealed no effect for preparation/information (n = 4, 313 participants) or suggestion (n = 3, 218 participants) for any pain or distress outcome. Given only a single trial, we could draw no conclusions about memory alteration. Adverse events of respiratory difficulties were only reported in one breathing intervention. AUTHORS' CONCLUSIONS: We identified evidence supporting the efficacy of distraction, hypnosis, combined CBT, and breathing interventions for reducing children's needle-related pain or distress, or both. Support for the efficacy of combined CBT and breathing interventions is new from our last review update due to the availability of new evidence. The quality of trials and overall evidence remains low to very low, underscoring the need for improved methodological rigor and trial reporting. Despite low-quality evidence, the potential benefits of reduced pain or distress or both support the evidence in favor of using these interventions in clinical practice.

Non-pharmacological management of infant and young child procedural pain.

BACKGROUND: Infant acute pain and distress is commonplace. Infancy is a period of exponential development. Unrelieved pain and distress can have implications across the lifespan.  This is an update of a previously published review in the Cochrane Database of Systematic Reviews, Issue 10 2011 entitled 'Non-pharmacological management of infant and young child procedural pain'. OBJECTIVES: To assess the efficacy of non-pharmacological interventions for infant and child (up to three years) acute pain, excluding kangaroo care, and music. Analyses were run separately for infant age (preterm, neonate, older) and pain response (pain reactivity, immediate pain regulation).  SEARCH METHODS: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 2 of 12, 2015), MEDLINE-Ovid platform (March 2015), EMBASE-OVID platform (April 2011 to March 2015), PsycINFO-OVID platform (April 2011 to February 2015), and CINAHL-EBSCO platform (April 2011 to March 2015). We also searched reference lists and contacted researchers via electronic list-serves. New studies were incorporated into the review. We refined search strategies with a Cochrane-affiliated librarian. For this update, nine articles from the original 2011 review pertaining to Kangaroo Care were excluded, but 21 additional studies were added. SELECTION CRITERIA: Participants included infants from birth to three years. Only randomised controlled trials (RCTs) or RCT cross-overs that had a no-treatment control comparison were eligible for inclusion in the analyses. However, when the additive effects of a non-pharmacological intervention could be assessed, these studies were also included. We examined studies that met all inclusion criteria except for study design (e.g. had an active control) to qualitatively contextualize results. There were 63 included articles in the current update. DATA COLLECTION AND ANALYSIS: Study quality ratings and risk of bias were based on the Cochrane Risk of Bias Tool and GRADE approach. We analysed the standardized mean difference (SMD) using the generic inverse variance method. MAIN RESULTS: Sixty-three studies, with 4905 participants, were analysed. The most commonly studied acute procedures were heel-sticks (32 studies) and needles (17 studies). The largest SMD for treatment improvement over control conditions on pain reactivity were: non-nutritive sucking-related interventions (neonate: SMD -1.20, 95% CI -2.01 to -0.38) and swaddling/facilitated tucking (preterm: SMD -0.89; 95% CI -1.37 to -0.40). For immediate pain regulation, the largest SMDs were: non-nutritive sucking-related interventions (preterm: SMD -0.43; 95% CI -0.63 to -0.23; neonate: SMD -0.90; 95% CI -1.54 to -0.25; older infant: SMD -1.34; 95% CI -2.14 to -0.54), swaddling/facilitated tucking (preterm: SMD -0.71; 95% CI -1.00 to -0.43), and rocking/holding (neonate: SMD -0.75; 95% CI -1.20 to -0.30). Fifty two of our 63 trials did not report adverse events. The presence of significant heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of very low quality evidence. AUTHORS' CONCLUSIONS: There is evidence that different non-pharmacological interventions can be used with preterms, neonates, and older infants to significantly manage pain behaviors associated with acutely painful procedures. The most established evidence was for non-nutritive sucking, swaddling/facilitated tucking, and rocking/holding. All analyses reflected that more research is needed to bolster our confidence in the direction of the findings. There are significant gaps in the existing literature on non-pharmacological management of acute pain in infancy.

Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents.

OBJECTIVE: To systematically review the evidence (and quality) for distraction and hypnosis for needle-related pain and distress in children and adolescents. To explore the effects of distraction characteristics (e.g., adult involvement, type of distracter), child age, and study risk of bias on treatment efficacy. METHODS: 26 distraction and 7 hypnosis trials were included and self-report, observer-report, and behavioral pain intensity and distress examined. Distraction studies were coded for 4 intervention characteristics, and all studies coded for child age and study risk of bias. RESULTS: Findings showed strong support for distraction and hypnosis for reducing pain and distress from needle procedures. The quality of available evidence was low, however. Characteristics of distraction interventions, child age, and study risk of bias showed some influence on treatment efficacy. CONCLUSIONS: Distraction and hypnosis are efficacious in reducing needle-related pain and distress in children. The quality of trials in this area needs to be improved.

Psychological interventions for needle-related procedural pain and distress in children and adolescents.

BACKGROUND: This review is an updated version of the original Cochrane review published in Issue 4, 2006. Needle-related procedures are a common source of pain and distress for children. Our previous review on this topic indicated that a number of psychological interventions were efficacious in managing pediatric needle pain, including distraction, hypnosis, and combined cognitive behavioural interventions. Considerable additional research in the area has been published since that time. OBJECTIVES: To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. SEARCH METHODS: Searches of the following databases were conducted for relevant randomized controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Web of Science. Requests for relevant studies were also posted on various electronic list servers. We ran an updated search in March 2012, and again in March 2013. SELECTION CRITERIA: Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only RCTs with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and assessed trial quality and a third author helped with data extraction and coding for one non-English study. Included studies were coded for quality using the Cochrane Risk of bias tool. Standardized mean differences with 95% confidence intervals were computed for all analyses using Review Manager 5.2 software. MAIN RESULTS: Thirty-nine trials with 3394 participants were included. The most commonly studied needle procedures were venipuncture, intravenous (IV) line insertion, and immunization. Studies included children aged two to 19 years, with the most evidence available for children under 12 years of age. Consistent with the original review, the most commonly studied psychological interventions for needle procedures were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majority of included studies (19 of 39) examined distraction only. The additional studies from this review update continued to provide strong evidence for the efficacy of distraction and hypnosis. No evidence was available to support the efficacy of preparation and information, combined CBT (at least two or more cognitive or behavioural strategies combined), parent coaching plus distraction, suggestion, or virtual reality for reducing children's pain and distress. No conclusions could be drawn about interventions of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as evidence was available from single studies only. In addition, the Risk of bias scores indicated several domains with high or unclear bias scores (for example, selection, detection, and performance bias) suggesting that the methodological rigour and reporting of RCTs of psychological interventions continue to have considerable room for improvement. AUTHORS' CONCLUSIONS: Overall, there is strong evidence supporting the efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents, with no evidence currently available for preparation and information or both, combined CBT, parent coaching plus distraction, suggestion, or virtual reality. Additional research is needed to further assess interventions that have only been investigated in one RCT to date (that is, memory alteration, parent positioning plus distraction, blowing out air, and distraction plus suggestion). There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress.

Non-pharmacological management of infant and young child procedural pain.

BACKGROUND: Infant acute pain and distress is commonplace. Infancy is a period of exponential development. Unrelieved pain and distress can have implications across the lifespan.  OBJECTIVES: To assess the efficacy of non-pharmacological interventions for infant and child (up to three years) acute pain, excluding breastmilk, sucrose, and music. Analyses accounted for infant age (preterm, neonate, older) and pain response (pain reactivity, pain-related regulation).  SEARCH STRATEGY: We searched CENTRAL in The Cochrane Library (2011, Issue 1), MEDLINE (1966 to April 2011), EMBASE (1980 to April 2011), PsycINFO (1967 to April 2011), Cumulative Index to Nursing and Allied Health Literature (1982 to 2011), Dissertation Abstracts International (1980 to 2011) and www.clinicaltrials.gov. We also searched reference lists and contacted researchers via electronic list-serves. SELECTION CRITERIA: Participants included infants from birth to three years. Only randomized controlled trials (RCTs) or RCT cross-overs that had a no-treatment control comparison were eligible for inclusion in the analyses. We examined studies that met all inclusion criteria except for study design (e.g. had an active control) to qualitatively contextualize results. DATA COLLECTION AND ANALYSIS: We refined search strategies with three Cochrane-affiliated librarians. At least two review authors extracted and rated 51 articles. Study quality ratings were based on a scale by Yates and colleagues. We analyzed the standardized mean difference (SMD) using the generic inverse variance method. We also provided qualitative descriptions of 20 relevant but excluded studies. MAIN RESULTS: Fifty-one studies, with 3396 participants, were analyzed. The most commonly studied acute procedures were heel-sticks (29 studies) and needles (n = 10 studies). The largest SMD for treatment improvement over control conditions on pain reactivity were: non-nutritive sucking-related interventions (preterm: SMD -0.42; 95% CI -0.68 to -0.15; neonate: SMD -1.45, 95% CI -2.34 to -0.57), kangaroo care (preterm: SMD -1.12, 95% CI -2.04 to -0.21), and swaddling/facilitated tucking (preterm: SMD -0.97; 95% CI -1.63 to -0.31). For immediate pain-related regulation, the largest SMDs were: non-nutritive sucking-related interventions (preterm: SMD -0.38; 95% CI -0.59 to -0.17; neonate: SMD -0.90, 95% CI -1.54 to -0.25), kangaroo care (SMD -0.77, 95% CI -1.50 to -0.03), swaddling/facilitated tucking (preterm: SMD -0.75; 95% CI -1.14 to -0.36), and rocking/holding (neonate: SMD -0.75; 95% CI -1.20 to -0.30). The presence of significant heterogeneity limited our confidence in the lack of findings for certain analyses. AUTHORS' CONCLUSIONS: There is evidence that different non-pharmacological interventions can be used with preterms, neonates, and older infants to significantly manage pain behaviors associated with acutely painful procedures.

Can we screen young children for their ability to provide accurate self-reports of pain?

No validated screening tasks exist to distinguish children who can accurately use self-report pain measures from those who cannot. Children aged 3-7 years (n=108), each with a parent, provided data before and after day surgery. Parents rated how well they thought their child could understand the Faces Pain Scale-Revised (FPS-R), and children completed 4 screening tasks in counterbalanced order, such as rating pain in vignettes and selecting a middle-sized cup. Parents and children used the FPS-R to rate the children's pain intensity. Children's FPS-R ratings were scored for accuracy based on the extent to which they conformed to expected pain trajectories (e.g., pain increasing following surgery, decreasing following analgesia), and based on parent-child agreement. On average, parents rated the youngest age at which children could understand the FPS-R as 4.4 years (95% confidence interval 4.1-4.5). The youngest children provided inaccurate high pain ratings before surgery, but they became indistinguishable from the oldest in the accuracy of their pain ratings for the remainder of the 3-day study period, suggesting that direct experience with pain or with the rating task may improve accuracy. Although children's performance on the screening tasks was significantly associated with self-report accuracy, no prediction was strong enough for clinical use (all r's < 0.30). We failed to identify a screening tool that was better than chronological age in identifying which children could accurately self-report pain using the FPS-R. Future research should explore other screening tasks, training methods, and simplified approaches to pain assessment for young children. The ability to use self-report pain scales usually develops from age 3 to 7 years, but no valid screening method exists to identify this achievement.

Assessing the quality of randomized controlled trials examining psychological interventions for pediatric procedural pain: recommendations for quality improvement.

OBJECTIVE: Systematic reviews of randomized controlled trials (RCTs) support the efficacy of psychological interventions for procedural pain management. However, methodological limitations (e.g., inadequate randomization) have affected the quality of this research, thereby weakening RCT findings. METHODS: Detailed quality coding was conducted on 28 RCTs included in a systematic review of psychological interventions for pediatric procedural pain. RESULTS: The majority of RCTs were of poor to low quality (criteria reported in <50% of RCTs). Commonly reported criteria addressed study background, conditions, statistical analyses, and interpretation of results. Commonly nonreported criteria included treatment administration, evaluation of treatment efficacy (effect sizes, summary statistics, intention-to-treat analyses), caregiver demographics, follow-up, and participant flow. Quality was greater in more recent trials, and did not vary by journal type (psychology vs. medical). CONCLUSION: Despite poor quality ratings, quality reporting in psychological RCTs for pediatric procedural pain has improved over time. Recommendations for quality enhancement are provided.

Psychological interventions for reducing pain and distress during routine childhood immunizations: a systematic review.

BACKGROUND: Immunizations are a common source of pain and distress for children. Psychological interventions consist of a variety of techniques for relaxing and distracting children during immunization with the goal of reducing pain and distress. OBJECTIVE: We conducted a systematic review to determine the efficacy of various psychological strategies for reducing pain and distress in children during routine immunizations. METHODS: MEDLINE, PsycINFO, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials databases were searched to identify randomized controlled trials (RCTs) and quasi-RCTs that determined the effect of psychological interventions on pain and distress during injection of vaccines in children 0 to 18 years of age, using validated child self-reported pain or observer-reported assessments of child distress or pain. We examined the efficacy of 7 psychological interventions: (1) breathing exercises; (2) suggestion; (3) child-directed distraction; (4) parent-led distraction; (5) nurse-led distraction; (6) parent coaching; and (7) combined cognitive-behavioral interventions. All meta-analyses were performed using a fixed-effects model. RESULTS: Twenty RCTs involving 1380 infants and children (1 month to 11 years of age) were included in the systematic review. Breathing exercises were effective in reducing children's self-reported pain (standardized mean difference [SMD], -0.43; 95% CI, -0.76 to -0.09; P = 0.01), observer-rated distress (SMD, -0.40; 95% CI, -0.68 to -0.11; P = 0.007), and nurse-reported distress (SMD, -0.57; 95% CI, -0.98 to -0.17; P = 0.005). Self-reported distress ratings appeared to be lower with breathing exercises, but the difference was not statistically significant. No evidence was found to support suggestion as a psychological intervention for reducing pain associated with pediatric immunization. Child-directed distraction was effective in reducing self-reported pain (SMD, -0.28; 95% CI, -0.54 to -0.03; P = 0.03). Parent-led distraction was effective in reducing observer-rated distress (SMD, -0.50; 95% CI, -0.82 to -0.19; P = 0.002), but not other measures of pain or distress. Nurse-led distraction was effective in reducing distress ratings as assessed by the observer (SMD, -0.40; 95% CI, -0.68 to -0.12; P = 0.005), the parent (SMD, -0.37; 95% CI, -0.66 to -0.07; P = 0.01), and the nurse (SMD, -0.42; 95% CI, -0.70 to -0.14; P = 0.004). Parent coaching was effective in reducing observer-rated distress (SMD, -0.71; 95% CI, -1.02 to -0.39; P < 0.001), but not other measures of pain or distress. Combined cognitive-behavioral interventions were effective in reducing children's self-reported pain (SMD, -0.75; 95% CI, -1.03 to -0.48; P < 0.001), observer-rated distress (SMD, -0.53; 95% CI, -0.83 to -0.23; P < 0.001), and parent-rated distress (SMD, -0.97; 95% CI, -1.37 to -0.57; P < 0.001). The methodologic quality of the included trials was generally poor, with 18 (90%) of the 20 studies rated as having a high risk of bias. CONCLUSIONS: Evidence suggests that breathing exercises, child-directed distraction, nurse-led distraction, and combined cognitive-behavioral interventions are effective in reducing the pain and distress associated with routine childhood immunizations. Although additional well-designed trials examining psychological interventions are needed, parents and health care professionals should be advised to incorporate psychological interventions to reduce the pain and distress experienced by children during immunization.

A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review.

OBJECTIVE: To report the results of a systematic review of randomized controlled trials (RCTs) of psychological interventions for children and adolescents undergoing needle-related procedures. METHODS: A variety of cognitive-behavioral psychological interventions for managing procedural pain and distress in children and adolescents between 2 and 19 years of age were examined. Outcome measures included pain and distress as assessed by self-report, observer report, behavioral/observational measures, and physiological correlates. RESULTS: Twenty-eight trials met the criteria for inclusion in the review and provided the data necessary for pooling the results. Together, the trials included 1,039 participants in treatment conditions and 951 in control conditions. The largest effect sizes for treatment improvement over control conditions were found for distraction, combined cognitive-behavioral interventions, and hypnosis, with promising but limited evidence for several other psychological interventions. CONCLUSIONS: Recommendations for conducting future RCTs are provided, and particular attention to the quality of trial design and reporting is highlighted.

Differences in high and low anxiety sensitive women's responses to a laboratory-based cold pressor task.

Anxiety sensitivity (AS) has been linked to a variety of disabling chronic health conditions, including pain-related conditions. A recent study has found that healthy women with high AS reported significantly higher levels of sensory and affective pain on an experimental cold pressor task compared to women with low AS. However, this study found no differences between AS groups for pain tolerance or pain threshold. In the present study, which was designed to replicate and extend these findings, 90 undergraduate university women were selected for inclusion in 1 of 2 AS groups (high or low) based on their screening scores on a 16-item measure of AS. Participants were tested individually on a lab-based cold pressor task using a variety of self-report and observer-measured variables. Data analyses revealed that, as expected, the high AS participants reported significantly more fear in response to the cold pressor on a relevant item of the McGill Pain Questionnaire-Short Form (SF-MPQ) than did the low AS participants. Also as expected, the high AS participants reported more pain in response to the cold pressor on the Present Pain Index (PPI) of the SF-MPQ than did the low AS participants. High AS participants did not differ from low AS participants on other aspects of the cold pressor response (e.g. pain threshold, pain tolerance, pain recovery). These results support the role of pain-related fear as a mediating variable between AS and increased perceived pain intensity.

A brief cognitive-behavioral approach to reducing anxiety sensitivity decreases pain-related anxiety.

Anxiety sensitivity (AS; fear of anxiety-related sensations) is a known risk factor for anxiety disorders and recently has been linked to pain disorders. The present study was guided by the hypothesis that a program designed to reduce AS levels might also result in a decrease in anxiety related to pain sensations. Female undergraduates, selected as either high or low in AS according to screening scores on the Anxiety Sensitivity Index (ASI), were randomly assigned to participate in 3 1-hour, small group sessions of either cognitive behavioral therapy (CBT; psycho-education, cognitive restructuring, and interoceptive exposure) or a non-specific treatment (NST). Immediately prior to and following the intervention, participants completed the 20-item Pain Anxiety Symptoms Scale (PASS-20). Consistent with hypothesis, results revealed a 3-way interaction between AS group, intervention condition, and time on PASS-20 total scores. Only participants with high pre-morbid levels of AS assigned to the CBT condition showed a significant reduction in scores on the PASS-20 from pre- to post-treatment. Implications for improving CBT approaches for pain disorders are discussed.