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.
To assess the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Central artery stiffness has emerged over the past 15 years as a clinically significant indicator of cardiovascular function and initiator of disease. Loss of elastic fiber integrity is one of the ...primary contributors to increased arterial stiffening in aging, hypertension, and related conditions. Elastic fibers consist of an elastin core and multiple glycoproteins; hence defects in any of these constituents can adversely affect arterial wall mechanics. In this paper, we focus on mechanical consequences of the loss of fibulin-5, an elastin-associated glycoprotein involved in elastogenesis. Specifically, we compared the biaxial mechanical properties of five central arteries-the ascending thoracic aorta, descending thoracic aorta, suprarenal abdominal aorta, infrarenal abdominal aorta, and common carotid artery-from male and female wild-type and fibulin-5 deficient mice. Results revealed that, independent of sex, all five regions in the fibulin-5 deficient mice manifested a marked increase in structural stiffness but also a marked decrease in elastic energy storage and typically an increase in energy dissipation, with all differences being most dramatic in the ascending and abdominal aortas. Given that the primary function of large arteries is to store elastic energy during systole and to use this energy during diastole to work on the blood, fibulin-5 deficiency results in a widespread diminishment of central artery function that can have significant effects on hemodynamics and cardiac function.
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.
Systematic reviews and meta-analyses Uman, Lindsay S
Journal of the Canadian Academy of Child and Adolescent Psychiatry
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Journal Article
Needle-related procedures are a common source of pain and distress for children. Several psychological (cognitive-behavioral) interventions to help manage or reduce pain and distress are available; ...however, a previous comprehensive systematic review of the efficacy of these interventions has not been conducted.
To assess the efficacy of cognitive-behavioral psychological interventions for needle-related procedural pain and distress in children and adolescents.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4, 2005), MEDLINE (1966 to 2005), PsycINFO (1887 to 2005), EMBASE (1974 to 2005), the Cumulative Index to Nursing and Allied Health Literature (1982 to 2005), Web of Science (1980 to 2005), and Dissertation-Abstracts International (1980 to 2005). We also searched citation lists and contacted researchers via various electronic list-servers and via email requests.
Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only randomized controlled trials (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.
Two review authors independently extracted data and assessed trial quality. Included studies were coded for quality using the Oxford Quality Scale devised by Jadad and colleagues. Standardized mean differences with 95% confidence intervals were computed for all analyses using RevMan 4.0 software.
Twenty eight trials with 1951 participants were included. Together, these studies included 1039 participants in treatment conditions and 951 in control conditions. The most commonly studied needle-procedures were immunizations and injections. The largest effect sizes for treatment improvement over control conditions exist for distraction (on self-reported pain, SMD -0.24 (95% CI -0.45 to -0.04), combined cognitive-behavioral interventions--reduced other-reported distress (SMD -0.88, 95% CI -1.65 to -0.12; and behavioral measures of distress (SMD -0.67, 95% CI -0.95 to -0.38) with hypnosis being the most promising--self-reported pain (SMD -1.47, 95% CI -2.67 to -0.27), with promising but limited evidence for the efficacy of numerous other psychological interventions, such as information/preparation, nurse coaching plus distraction, parent positioning plus distraction, and distraction plus suggestion.
Overall, there is preliminary evidence that a variety of cognitive-behavioral interventions can be used with children and adolescents to successfully manage or reduce pain and distress associated with needle-related procedures. However, many of the included studies received lower quality scores because they failed to describe the randomization procedure and participant withdrawals or drop-outs from the study. Further RCTs need to be conducted, particularly for the many interventions for which we could not locate any trials.
Myocardial infarction (MI) produces acute changes in strain and stiffness within the infarct that can affect remote areas of the left ventricle (LV) and drive pathological remodeling. We hypothesized ...that intramyocardial delivery of a hydrogel within the MI region would lower wall stress and reduce adverse remodeling in Yorkshire pigs (n = 5). 99mTc-Tetrofosmin SPECT imaging defined the location and geometry of induced MI and border regions in pigs, and in vivo and ex vivo contrast cine computed tomography (cineCT) quantified deformations of the LV myocardium. Serial in vivo cineCT imaging provided data in hearts from control pigs (n = 3) and data from pigs (n = 5) under baseline conditions before MI induction, post-MI day 3, post-MI day 7, and one hour after intramyocardial delivery of a hyaluronic acid (HA)-based hydrogel with shear-thinning and self-healing properties to the central infarct area. Isolated, excised hearts underwent similar cineCT imaging using an ex vivo perfused heart preparation with cyclic LV pressurization. Deformations were evaluated using nonlinear image registration of cineCT volumes between end-diastole (ED) and end-systole (ES), and 3D Lagrangian strains were calculated from the displacement gradients. Post-MI day 3, radial, circumferential, maximum principal, and shear strains were reduced within the MI region (p < 0.04) but were unchanged in normal regions (p > 0.6), and LV end diastolic volume (LV EDV) increased (p = 0.004), while ejection fraction (EF) and stroke volume (SV) decreased (p < 0.02). Post-MI day 7, radial strains in MI border zones increased (p = 0.04) and dilation of LV EDV continued (p = 0.052). There was a significant negative linear correlation between regional radial and maximum principal/shear strains and percent infarcted tissue in all hearts (R2 > 0.47, p < 0.004), indicating that cineCT strain measures could predict MI location and degree of injury. Post-hydrogel day 7 post-MI, LV EDV was significantly reduced (p = 0.009), EF increased (p = 0.048), and radial (p = 0.021), maximum principal (p = 0.051), and shear strain (p = 0.047) increased within regions bordering the infarct. A smaller strain improvement within the infarct and normal regions was also noted on average along with an improvement in SV in 4 out of 5 hearts. CineCT provides a reliable method to assess regional changes in strains post-MI and the therapeutic effects of intramyocardial hydrogel delivery.
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•Developed novel platform to assess left ventricle deformation in vivo and ex vivo.•Local cardiac strains decreased progressively over 7 days in infarcted regions.•Measured linear correlation between local degree of infarction and strain.•Hydrogel injection improved strain in regions bordering the infarct.•Hydrogel injection resulted in less ventricle dilation and larger ejection fraction.
Abstract 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.
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.
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.
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.
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.
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.
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.
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.
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'.
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).
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.
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.
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.
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.
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.
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