Abstract

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.

Author(s)

Kathryn A Birnie, Melanie Noel, Christine T Chambers, Lindsay S Uman, Jennifer A Parker

Abstract

Plain language summary

Psychological strategies to reduce pain and distress for children and adolescents getting needles

Bottom line

Psychological strategies help reduce children's pain, distress, and fear of needles. Distraction and hypnosis are helpful, although specific breathing (such as inflating a balloon), and combining multiple psychological strategies can also help.

Background

Psychological strategies affect how children think or what they do before, during, or after a needle. They can be used by children or with support from parents or medical staff, like nurses, psychologists, or child life specialists. The information applies to children aged from two to 19 years who are healthy or ill, undergoing all types of needle procedures at the hospital, in a clinic, or at school.

Key results

For this update, in September 2017, we searched for clinical trials looking at psychological strategies for reducing pain and distress of children and teens getting a needle. We found 59 trials including 5550 children and teens. Twenty of these trials were new for this update. We found six psychological strategies, four of which help reduce children's pain and distress during needles. These include distraction, hypnosis, specific breathing, and combining multiple strategies (‘combined cognitive behavioral’). Ways to distract children and teens during needles include reading, watching a movie, listening to music, playing video games, or virtual reality. Hypnosis involves deep relaxation and imagery, and is usually taught to a child by a trained professional. Examples of strategies that can be combined include distraction, breathing, relaxation, positive thoughts, having the child learn or practice the steps of the needle procedure, and coaching parents about ways to support their child. Other psychological strategies have been tested but do not seem helpful on their own. For example, children do not have less pain or distress when they are only told what is going to happen before or during the needle ('providing information or preparation or both) or when someone merely suggests to the child that something is being done to help them. One other strategy is helping children to remember their previous needles more positively. There is not enough information yet to know if this is helpful.

Quality of evidence

We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. The quality of the evidence from this review is very low to low, as results may be biased by including only small numbers of children or by children knowing what psychological intervention they received. This means that we are uncertain about the results.

Author(s)

Kathryn A Birnie, Melanie Noel, Christine T Chambers, Lindsay S Uman, Jennifer A Parker

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

The findings of this review support the efficacy of distraction, hypnosis, combined CBT, and breathing interventions for reducing children’s needle‐related pain and distress. Despite very low‐ to low‐quality evidence across psychological interventions, the potentially desirable outcomes and value of reduced pain or distress or both provide justification for their use in clinical practice (Andrews 2013a; Andrews 2013b; Higgins 2017).

Clinically, distraction interventions can be used during a variety of routine and more invasive needle procedures across a range of outpatient, inpatient, community, and emergency‐care settings. Findings suggest that a variety of distractors are efficacious; thus, the type of distraction intervention (e.g. books, verbal distraction, virtual reality) does not seem to matter. The evidence supports clinicians using distraction interventions as appropriate for their setting, availability, resources, and expertise. These are particularly useful psychological interventions for even low‐resourced areas and can be feasibly delivered by any healthcare provider. Although parents could potentially deliver distraction interventions, their efficacy is questionable among parents with higher levels of anxiety (Dahlquist 2005). We also assert that these interventions may not be useful for children with significant needle fears who require more intensive, exposure‐based psychological interventions (McMurtry 2016).

Findings also continue to support the use of hypnosis for the management of children’s pain and distress during needle procedures. Hypnosis is particularly applicable in the context of more invasive needle‐related procedures for children with cancer (e.g. bone marrow aspirations, lumbar punctures). Practically speaking, hypnosis requires clinician training for professionals or parents or training in self‐hypnosis for children, and probably greater resources (e.g. time) to implement, which may limit the feasibility of these interventions in some clinical settings.

While we found preliminary support for the use of some basic breathing interventions (e.g. balloon inflation, deep breathing), three adverse events were reported in one of these trials, with children discontinuing intervention due to respiratory difficulties (Pourmovahed 2013). Indeed, the appropriateness of each intervention may differ across settings and clinical populations.

Although we found combined CBT interventions to be efficacious in reducing observer‐reported pain and behavioral distress, findings did not support the use of combined CBT for other outcomes, most notably self‐report. This suggests that increased efforts (time, resources) towards combining elements of CBT in multi‐pronged interventions may not be worthwhile or grounded in evidence. Single‐strategy interventions, i.e. hypnosis, distraction, and breathing, were the only interventions found to be efficacious in reducing child self‐report of pain in this setting. Providing preparatory information alone or merely suggesting something was being done to reduce pain or distress was not effective for any outcomes.

Although the findings here are drawn from studies including children from two to 19 years old, most studies focused on children aged 12 and younger. It is therefore difficult to ascertain the efficacy of interventions for children of particular ages, particularly adolescents. Overall, the implications for practice described here are most directly applicable to children aged 12 and under.

Research knowledge of the efficacy of psychological interventions to reduce needle pain and distress is of little value unless that knowledge is disseminated and taken up into clinical practice. Researchers, clinicians, policy‐makers, parents, and other knowledge users are strongly encouraged to use the evidence reviewed here to inform dissemination and implementation of efficacious psychological strategies to needle procedure and pain management practice. Examples include clinical practice guidelines (Taddio 2015; McMurtry 2016), standards of care (Flowers 2015), institutional policies (ChildKind International; www.childkindinternational.org; Schechter 2008; Schechter 2010a; WHO 2015), and videos and pamphlets targeting healthcare providers and parents (Chambers 2013; www.youtube.com/watch?v=KgBwVSYqfps; Chambers 2016; www.parentscanada.com/health/expert-advice-to-help-make-vaccinations-easier). It is critical to ensure that research evidence reaches those who need it and will use it.

Implications for research 

1. General Implications

Examining psychological interventions to reduce needle‐related pain and distress experienced by children and adolescents is a large and very active area of research. For those interventions that are shown to be efficacious, it is time to turn our research attention to ensuring that dissemination of such knowledge is timely, meaningful, and effective. We are referring to the need for empirical evaluation of factors that increase the uptake of intervention strategies into clinical practice, a field known as implementation science (Bauer 2015; Curran 2012; Wittmeier 2015). This is a critical and worthy research endeavor. Several new studies included in this updated review continue to include standard care for needle procedures with children that exclude evidence‐based pain management strategies identified in our original review (Uman 2006). This reflects a lag of more than 11 years to move research evidence into practice, and highlights the need for concerted efforts to reduce this evidence‐to‐practice gap (Morris 2011).

We continue to assert that future studies comparing distraction interventions to standard care are of little value, given continued support for their efficacy. To advance treatment research in this area, studies should include head‐to‐head comparisons of different types of distraction interventions (Birnie 2014a). This has seldom been done, with some exception (Aydin 2017; Bellieni 2006; Miller 2016; Sahiner 2016). We also note a clear lack of evidence and need for future trials of interventions that are frequently used in clinical practice, widely accessible, and potentially deliverable through e‐health or m‐health platforms (e.g. smartphones, tablets). More trials are needed for those interventions covered only by single trials (e.g. memory alteration) and for those where there has been little new evidence in the past several years (e.g. hypnosis). Given the integral role of parents in children’s experience of needle‐related pain and fear, and their presence during these procedures, additional trials involving parents are needed.

2. Design

At this point in time, strong emphasis should be placed on clinical equipoise when designing clinical trials in this area. Robust evidence exists for the efficacy of particular psychological interventions (distraction, hypnosis) in reducing children’s needle‐related distress and pain; there should therefore not be any new trials in which a comparison group receives less than standard care (i.e. some form of evidence‐based pain relief, such as topical anesthetic). The use of placebo or no‐analgesia control groups has been strongly condemned in clinical trials of analgesic treatments for procedural pain in infants, with calls for ethics committees and journals not to approve or publish such trials (Bellieni 2016). Given the evidence in this review, it is reasonable to apply the same expectations that trials stop implementing no‐treatment comparison groups to children and adolescents. Although some trials have moved to including pain management interventions in their standard‐care control groups (distraction, Crevatin 2016; topical anesthetics, Miller 2016), we continue to note inconsistencies in this regard across the evidence base.

Researchers should carefully follow the CONSORT guidelines (Moher 2010; www.consort-statement.org) when reporting randomized trials to ensure that details relevant to randomization, allocation, and blinding are adequately addressed. We continue to strongly encourage researchers to draw from available standards and guidelines for designing pediatric trials (StaR Child Health) informing recruitment, consent (Caldwell 2012), sample size estimation (Van der Tweel 2012), minimizing risk of bias (Hartling 2012), considering developmental stage (Williams 2012), and outcome selection, assessment, and reporting (Sinha 2012; PedIMMPACT McGrath 2008; CONSORT, Altman 2001). All trials should be registered (clinicaltrials.gov or www.who.int.trialsearch).

3. Measurement

Trial reporting should include all outcomes necessary for meta‐analysis (e.g. means, SDs, participant cell sizes). Manuscripts should also clearly report the types and characteristics of all interventions used in sufficient detail to be understood and replicated by another clinician or researcher (Birnie 2014a). Findings from this second review update suggest that treatment efficacy differs across different outcomes; trials should therefore include a variety of primary outcomes beyond self‐report of pain, such as emotional response (e.g. distress, anxiety, fear, unhappiness), satisfaction with treatment, physical recovery, economic factors (e.g. costs), and adverse events and symptoms (PedIMMPACT; McGrath 2008). We suggest that self‐report be included among children who can provide valid and reliable self‐report (e.g. children aged four to five years and upwards; Von Baeyer 2017); however, researchers should also strive to include reports of child pain and distress by others (e.g. parents, behavioral scales). We continue to encourage researchers to take all efforts to blind outcomes wherever possible (e.g. behavioral ratings coded from video).

4. Other

Future research efforts should focus on examining and confirming treatment mechanisms. This includes integration with other types of experimental designs and methods (e.g. neuroimaging, Birnie 2017). This research is particularly important for interventions where the mechanism of effect is unclear or where multiple potential mechanisms are involved. This is critical, as it directly informs the determination and design of most effective treatments, which are now difficult to determine given the significant heterogeneity within intervention categories such as distraction. Further research in this area may also inform more accurate categorization of psychological interventions. For example, breathing interventions in which children are instructed to inflate a balloon may evoke a physiological mechanism, expectancy, or distraction (Gupta 2006; Sahiner 2016).

We encourage researchers to conduct studies informing how to tailor the right intervention to the right child at the right time. Interventions should ideally be matched to child, setting, and context. Individual differences will invariably influence responsiveness to psychological interventions. For example, children with high versus low fear of pain or tendencies to catastrophize about pain may benefit less from distraction (Birnie 2017; Campbell 2017; Verhoeven 2012) and more from hypnosis that involves more intensive training, attentional engagement, and suggestion. The influence of participant preference and choice on treatment efficacy should also be considered (Birnie 2014a). Particularly in the context of vaccination, there is a notable dearth of interventions delivered in the school setting. Given that school‐aged children and adolescents often receive vaccine injections in this setting, research in this unique context would be valuable (Boerner 2014).

Once again, we argue it is imperative that future trials take into account the child’s age and developmental stage when developing, implementing, and evaluating interventions. There was a notable lack of trials specifically targeting adolescents, and participant samples included a wide range of children spanning several developmental periods. Age can influence treatment efficacy in these interventions (Birnie 2014a). We suggest that studies including a wide age range of children used age‐based analyses and report outcomes by recommended age groups for pediatric clinical trials (Williams 2012). Previous experience with and associated memories of needle procedures also invariably influence the child’s pain experience and treatment responsiveness (Noel 2012). Comparison of intervention efficacy for single (vaccine injection) versus repeated needle procedures (bone marrow aspirations for cancer treatment regimens) is warranted. Relatedly, trials examining intervention implementation and efficacy among youth with developmental disabilities are notably absent from the literature and are needed (Boerner 2014).

Finally, wide dissemination of efficacious interventions is critically important and can be threatened by real‐world concerns about time, resources, and feasibility in busy clinical settings. Given that our findings suggest a variety of distraction interventions are efficacious regardless of cost and level of technology, cost effectiveness should be assessed and considered. This is highly relevant for uptake of evidence‐based pain management in less resourced areas.

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