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. 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.