Benefits to Clinicians of Nonpharmacological Distraction During Pediatric Medical Procedure.

CONTEXT: Nonpharmacologic distraction (NPD) during medical procedures in children is known to be beneficial to patients; however, no reviews have assessed their benefits to medical providers. OBJECTIVES: We aimed to assess the benefits of NPD to medical providers. DATA SOURCES: We searched 5 databases for relevant articles. STUDY SELECTION: Peer-reviewed published randomized controlled trials comparing NPD with standard care that included children who had undergone medical procedures were included. DATA EXTRACTION: Primary outcomes were procedure time, number of medical staff involved, and initial success rate of venipuncture. Two reviewers assessed the risk of bias by using the Cochrane Collaboration (Oxford, United Kingdom)'s Randomized Controlled Trials Risk of Bias Tool, and we performed a meta-analysis to assess efficacy. RESULTS: We included 22 trials with 1968 participants. The main NPD was audiovisual distraction, such as tablets. No significant difference was found in venipuncture procedure time (mean difference: -9.79; 95% confidence interval: -22.38 to 2.81; low certainty). We found no studies on the number of medical staff. CONCLUSIONS: Our review did not find any clear NPD-associated benefit for the medical provider. The review included a small amount of literature, analyzed a small number of cases, and had a low certainty of evidence regarding procedure duration; therefore, further studies are needed to conclude the benefits to clinicians of NPD.

Child Emotion Regulation Capacity Moderates the Association Between Parent Behaviors and Child Distress During Pediatric Venipuncture.

OBJECTIVES: Medical needle procedures are a common source of pain, distress, and fear for children, which can worsen over time and lead to needle noncompliance and avoidance, if unaddressed. Children's pain experience is multiply determined by external (e.g., parent behaviors) and internal (e.g., cognitive and affective) factors. Some parent behaviors (e.g., reassurance, giving control to child, empathy, apologies, criticism) have related to poor child pain experiences. No research has examined how children's internal emotion regulation, commonly measured via heart rate variability (HRV), may buffer, or strengthen this association. This study is the first to examine child HRV in relation to pain experiences, and as a moderator between a constellation of parent behaviors (reassurance, giving control, empathy) and child pain, fear, and distress. METHODS: Sixty-one children aged 7-12 years undergoing venipuncture and a parent participated. Child HRV was measured before the procedure. After venipuncture, children rated their pain and fear. Parent and child behaviors during venipuncture were coded using the "distress promoting" and "distress" composites of the Child-Adult Medical Procedure Interaction Scale-Revised. RESULTS: Children with lower HRV displayed greater distress. Child HRV moderated the positive association between parent behaviors (reassurance, giving control, empathy) and child distress such that the association was strongest among children with low HRV. CONCLUSIONS: Findings suggest children with lower HRV, indicative of lower emotion regulation capacity, may be at risk of experiencing higher levels of distress and may be more vulnerable to distress when facing parent reassurance, giving control, and empathy verbalizations during venipuncture.

Vasovagal reactions following venepuncture result in aberrant stress-induced cortisol levels.

Venepuncture is recognized as a potent stressor and, by activating the hypothalamic-pituitary-adrenal (HPA) axis, can interfere with measuring subsequent HPA axis indices such as cortisol. A resting period of 110 min is recommended between venepuncture and the commencement of psychosocial stress induction or cortisol measurement to allow cortisol levels to return to baseline first. In experiment 1 (n = 65), in which stress induction occurred 120 min after venepuncture, we observed three cortisol stress response patterns: conventional response ("responders", 77%), conventional non-response ("non-responders", 6.15%), and aberrant non-response characterized by high baseline (pre-stress) cortisol levels ("high-baseliners", 16.9%). Based on subjective clinical observation, the aberrant non-response was exclusively present in those who experienced vasovagal reactions during venepuncture, ranging from nervousness, lightheadedness, nausea, feeling of being extremely hot or cold, confusion, slight inability to speak, weakness and visual disturbances, to loss of consciousness (syncope). In experiment 2 (n = 79), we showed that allowing 210 min between venepuncture and stress induction permits the return of cortisol levels back to baseline even in participants who experience vasovagal reactions, thereby allowing for the exhibition of a conventional cortisol stress response. In sum, while 110 min may be sufficient to circumvent the usual effects of venepuncture on cortisol levels, 210 min are needed to effectively adjust for the effects of venepuncture-induced vasovagal reactions and the subsequent sustained rise in cortisol. Allowing sufficient time between venepuncture and stress induction or cortisol measurement should also prevent misclassification of participants who show aberrant responses as non-responders or anticipatory responders.

Do professionals change their communication behaviours following a training in hypnosis-derived communication? A feasibility study in pediatric oncology.

OBJECTIVES: The purpose of this study was to test the feasibility of a training in hypnotic communication techniques (HCTech) for pediatric nurses to prevent procedural pain and distress in children during venipunctures. Specifically, this study aimed to (1) assess nurses' mastery of HCTech and (2) nurses' experience regarding the training program. METHODS: Participants were 6 female pediatric nurses and 33 of their cancer patients. Nurses took part in a 4-day theoretical and practical training in HCTech. Venipuncture procedures were video-recorded and assessed to evaluate nurses' mastery of HCTech using a standardized scale. Pre-training use of HCTech was compared with post-training and follow-up for the entire nurse sample and across nurses with the same patients (109 nurse-patient interactions). After the follow-up, nurses were questioned about their experience in regards to the training and activities (themes and practice). RESULTS: Results showed medium pre-post changes in hypnotic communication behaviours (pre-post d = 0.74), with changes maintaining at follow-up (pre-follow-up d = 0.97). Interviews transcripts' analyses revealed moderate levels of motivation and satisfaction regarding the training content and format. Nurses suggested to emphasize on the practice of HCTech in a noisy outpatient clinic as well as offer more practical exercises. CONCLUSION: A 4-day training in hypnotic communication techniques translated into the use of HCTech by nurses practicing in pediatric oncology when comparing the same dyads at baseline, post-training and follow-up. Results support further refinement and suggest nurses could be trained to prevent pain and distress with hypnosis-derived communication strategies.

Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study.

AIM AND OBJECTIVES: Virtual reality (VR) can be used during painful procedures in children. The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety of children aged 5-12 years old during blood draw. METHODS: This randomised controlled study used parallel trial design guided by the CONSORT checklist, see Supporting Information. The sample of children (n = 136) was allocated to the VR-Rollercoaster (n = 45), VR-Ocean Rift (n = 45) and control group (n = 46) using blocked randomisation. The primary outcome was pain scores after the blood draw and fear and anxiety scores before and after the blood draw. Before the blood draw, fear and anxiety scores were assessed using self-report and reports from the parents and the researcher using the Child Fear Scale and Children's Anxiety Meter. After the blood draw, level of pain experienced was assessed using the Wong-Baker Faces Pain Rating Scale and the fear and anxiety levels experienced by the children during the blood draw were re-evaluated. RESULTS: Pain scores were found to be lower in the VR-Rollercoaster group and the VR-Ocean Rift group. A statistical difference was found between groups according to self-, parent- and researcher-reported fear and anxiety scores after blood draw. While being in VR-Rollercoaster and VR-Ocean Rift group reduced children's fear and anxiety, being in the control group increased fear levels by 20% and anxiety levels by 34.1%. CONCLUSIONS: VR is an effective method in reducing procedure-related pain, fear and anxiety in children aged 5-12 years old during blood draw. RELEVANCE TO CLINICAL PRACTICE: Evidence-based guidelines and protocols should be created for nonpharmacological methods such as VR for procedural pain and anxiety in children.

The Effects of Caressing and Hugging Infants to Manage the Pain during Venipuncture.

The aim of this study is to investigate the effects of caressing in infants for pain management during venipuncture. This is a randomized control trial, carried out on 120 infants between 2 and 6 months of age, that included 30 males and 30 females in the hugging and control group, respectively. Parameters such as percentage blood saturation of blood, crying, and the duration of pain felt was evaluated. The venipuncture between the control and experimental groups showed that, less pain is felt by females when caressed by their mother. However, this difference does have statistical significance. Overall, caressing in infants had positive effect on pain-relief after venipuncture.

The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children.

PURPOSE: The study aimed to determine the effect of two different distractions on pain perceptions and anxiety during venipuncture in children. DESIGN: A randomized controlled study. METHODS: A total of 139 children aged between 4 and 10 years were included in the study: 46 of them in virtual reality goggle group and 43 in the control group. An information form, the Children's Anxiety Scale, Visual Analogue Scale, and Wong-Baker Faces Pain Scale were used in the collection of data. FINDINGS: Pain and anxiety scores were significantly lower in the virtual reality goggle and kaleidoscope group than in the control group (P < .000). CONCLUSIONS: The use of virtual reality goggle and kaleidoscope methods during venipuncture are effective in reducing children's perception of pain and anxiety. The most effective method of reducing perception of pain and anxiety is using the virtual reality goggle.

Virtual reality during pediatric vascular access: A pragmatic, prospective randomized, controlled trial.

BACKGROUND: Vascular access is a minor procedure that is associated with reported pain and fear in pediatric patients, often resulting in procedural incompliance. Virtual reality has been shown to be effective in adult populations for reducing pain and anxiety in various medical settings, although large studies are lacking in pediatrics. AIMS: The primary aim was to determine whether pain would be reduced in pediatric patients using virtual reality undergoing vascular access. The four secondary aims measured patient fear, procedural compliance, satisfaction, and adverse events. METHODS: A prospective, randomized, controlled trial was completed at a pediatric hospital, enrolling children 7-18 years old undergoing vascular access in a variety of clinical settings, randomized to virtual reality or standard of care. Pain scores were measured using a numeric pain faces scale. The secondary outcomes of patient fear, procedural compliance, satisfaction, and adverse events were measured with the Child Fear Scale, modified Induction Compliance Checklist, and satisfaction surveys, respectively. Chi-squared, t tests, and regression models were used to analyze the results. RESULTS: The analysis included 106 patients in the virtual reality group and 114 in the control. There were no significant differences in postprocedure pain (VR group estimated 0.11 points lower, 95% confidence interval: 0.50 points lower to 0.28 points greater, P = .59), postprocedure fear (VR group estimated 0.05 points lower, 95% confidence interval: 0.23 points lower to 0.13 points greater), or compliance (adjusted odds ratio 2.31, 95% confidence interval: 0.96-5.56). Children in the virtual reality group were satisfied with the intervention. There were no adverse events. CONCLUSION: This study demonstrates no reduction in pain while using Virtual reality (VR) across a heterogeneous pediatric inpatient population undergoing vascular access.

Urinary catecholamines during stress and ambulatory blood pressure in children born full term but small for gestational age: a pilot study.

OBJECTIVES: Increased sympathetic activity is proposed to be a mechanism of high blood pressure in children born small for gestational age. Ambulatory blood pressure monitoring is a form of blood pressure measurement that can detect high blood pressure outside the hospital in patients with normal office blood pressure. This condition is called masked hypertension. There are limited data on association between ambulatory blood pressure and urinary catecholamines during exposure to stress in children born small for gestational age. METHODS: Nineteen children born small for gestational age and 17 healthy controls ages 6-14 years old were included. Demographic data and office blood pressure were collected. Urinary catecholamines were collected before and after exposure to stress including mathematical test and venipuncture. Afterwards, ambulatory blood pressure monitoring was performed to obtain 24-hour blood pressure profiles. RESULTS: All children had normal office blood pressure but ambulatory blood pressure monitoring revealed masked hypertension in six children born small for gestational age (32%) and two controls (11.7%). After stress, median percentage of increase in urine norepinephrine levels was greater in children born small for gestational age with masked hypertension than that of children born small for gestational age without masked hypertension (9.2 vs. -13.2 µg/g creatinine, P = 0.05). There was no increase in urine norepinephrine levels in controls with masked hypertension. Among children born small for gestational age, awake SBP z-scores had significant positive correlations with pre- and post-stress urinary dopamine levels (r = 0.530, P = 0.02 and r = 0.597, P = 0.007, respectively). CONCLUSION: Masked hypertension is not uncommon in children born small for gestational age. After stress, urinary norepinephrine levels were increased in children born small for gestational age with masked hypertension.

Children's Pain, Fear, and Anxiety During Invasive Procedures.

This study was conducted to find out the effects of different means of games used during pediatric blood draw on the levels of procedure-induced fear and anxiety. Patient descriptive information form and selected scales were completed for both the experimental and control group before the blood drawing procedure. During the blood draw procedure, the children in the experimental group listened to music and watched video games. Following the blood draw procedure, the children were given the Fear of Medical Procedure Scale and State Anxiety Inventory for a second time. The results of the study showed that differences between pre- and postprocedure average total scores of Fear of Medical Procedure Scale were statistically significant for all groups (p < .05). As a conclusion, it was found that making children listen to music or watch a video during blood draw was effective in decreasing their medical procedure fear levels and state anxiety.

A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department.

Objective: A large number of children report fear and distress when undergoing blood work and intravenous placement. In pediatric departments, Child Life interventions are considered to be the gold standard in nonmedical pain management techniques. Virtual reality (VR) has also been identified as an effective tool for pain distraction in children undergoing painful medical procedures. The aim of this study was to document the efficacy of VR as a mode of distraction during a medical procedure compared with two comparison conditions: watching television (TV, minimal control condition) and distraction provided by the Child Life (CL, gold standard control condition) program. Materials and Methods: A total of 59 children aged 8-17 years (35% female) were recruited through the emergency department (ED) of the Children's Hospital of Eastern Ontario and randomly assigned to one of the three conditions. The key outcome measures were visual analog scale ratings of pain intensity and fear of pain, administrated before and right after the procedure. Patient satisfaction was also measured after the intervention. Results: A significant reduction in fear of pain and pain intensity was reported in all three conditions. A larger and statistically significant reduction in fear of pain was observed among children who used VR distraction compared with the CL and TV conditions, but this effect was not observed for pain intensity. The children's satisfaction with the VR procedure was significantly higher than for TV and comparable to CL. Discussion: The advantages of using VR in the ED to manage pain in children are discussed.

External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol.

INTRODUCTION: Needle-related procedures are considered as the most important source of pain and distress in children in hospital settings. Considering the physiological and psychological consequences that could result from these procedures, management of pain and distress through pharmacological and non-pharmacological methods is essential. Therefore, it is important to have interventions that are rapid, easy-to-use and likely to be translated into clinical practice for routine use. The aim of this study will be to determine whether a device combining cold and vibration (Buzzy) is non-inferior to a topical anaesthetic (liposomal lidocaine 4% cream) for pain management of children undergoing needle-related procedures in the emergency department. METHODS AND ANALYSIS: This study will be a randomised controlled non-inferiority trial comparing the Buzzy device to liposomal lidocaine 4% cream for needle-related pain management. A total of 346 participants will be randomly assigned in a 1:1 ratio to one of the two study groups. The primary outcome will be the mean difference in pain intensity between groups during needle-related procedures. A non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. A Non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. The secondary outcomes will be the level of distress during the procedure, the success of the procedure at first attempt, the occurrence of adverse events, the satisfaction of both interventions and the memory of pain 24 hours after the procedure. The primary outcome will be assessed for non-inferiority and the secondary outcomes for superiority. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the institutional review board of the study setting. Findings of this trial will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02616419.

Impact of a Child Life and Music Therapy Procedural Support Intervention on Parental Perception of Their Child's Distress During Intravenous Placement.

OBJECTIVES: Child life specialists and music therapists have a unique and integral role in providing psychosocial care to pediatric patients and families. These professionals are trained to provide clinical interventions that support coping and adjustment and reduce the risk of psychological trauma related to hospital visits and health care encounters. The researchers devised a multimodal approach using a combined child life and music therapy intervention to address procedure-related distress in patients receiving intravenous (IV) placement in the pediatric emergency department. The aim of this study was to investigate the efficacy of this collaborative intervention by evaluating parental perception of their child's distress. METHODS: This study was a prospective analysis investigating the impact of a child life and music therapy intervention on children aged 4 to 11 years old receiving an IV placement in the pediatric emergency department. Efficacy was evaluated by comparing scores between a 4-question pretest and subsequent 4-question posttest that asked the child's parent to evaluate how they anticipated their child would respond to the procedure, and then to evaluate how they perceived their child to have responded after the procedure. Qualitative data were collected in the form of open-ended comments, which were accommodated at the end of the posttest. Data were analyzed by the Cochran-Mantel-Haenszel method for testing repeated ordinal responses and the PROC GENMOD procedure in the SAS system software. RESULTS: A total of 41 participants were enrolled in this study. Results of the statistical analysis revealed significant differences between all pre- and posttest scores (P < 0.05), and significant likelihood that the patient would improve relative to the 4 questions, as a result of the child life and music therapy intervention. CONCLUSIONS: Improvement was demonstrated across all 4 questions, suggesting that the child life and music therapy intervention supported healthy, adaptive coping and helped to minimize distress experienced by patients during IV placement. These results underscore the importance and potential clinical impact of child life psychological preparation and psychotherapy-based music therapy interventions in reducing distress in pediatric patients during common medical procedures.

Expressive Behaviors Demonstrating "Well Done" in Young Children Undergoing Blood Sampling or Vaccination as Perceived by Parents and Nurses in Japan.

The present study aimed to clarify expressive behaviors demonstrating "well done" in young children aged 3-7 years who were undergoing blood sampling or vaccination, as these behaviors were perceived by parents and nurses in Japan. This study applied a qualitative descriptive design using a retrospective recall approach. Data obtained from semi-structured interviews conducted with 14 parents and 15 nurses were divided into meaning units, each containing a complete expressive behavior demonstrating "well done." These meaning units were then coded and categorized. A total of 103 secondary codes were extracted and grouped into 36 subcategories and the following six categories: emotional expression, exploratory behavior, moving on from blood sampling or vaccination, self-regulating behavior, expression of intentions to adults, and response to questioning by adults. The most common emotions displayed before needle removal in the category emotional expression were those related to "displeasure," while those displayed after needle removal were related to "pleasure." The present findings suggest that parents and nurses perceived the change from displeasure- to pleasure-related emotions after needle removal in young children as "well done." Observation of the expressive behaviors identified in the present study will enable the clinical evaluation of "well done" in young children undergoing blood sampling or vaccination, thereby aiding nurses in providing positive feedback to young children and their parents.

The effect of therapeutic phlebotomy for hemochromatosis on non-suicidal self-injury: A case report.

BACKGROUND: Self-phlebotomy has been described as a form of non-suicidal self-injury. However, a relationship between non-suicidal self-injury and therapeutic phlebotomy for hemochromatosis has not previously been described. Case presentation: We present a case of a 52-year-old man in whom the frequency of his therapeutic phlebotomy and non-suicidal self-injury were inversely linked, leading to adverse outcomes when his phlebotomy was suspended. CONCLUSIONS: This is the first report describing the relationship between non-suicidal self-injury and therapeutic phlebotomy. This case highlights the need for risk assessment and monitoring of self-harm in patients who are undergoing therapeutic phlebotomy in order to prevent adverse outcomes.

Young children experience little emotional burden during invasive procedures in asthma research.

Research in children should strike the right balance between protecting underage study subjects and advancing the medical field. This study gives insight into the emotional burden that common invasive research procedures in asthma research have on young children, both from the child and parent perspective. Puppetry was used to stimulate children (age 5-6 years) to explain their emotional burden prior to and after the research procedures. We operationalised emotional burden as willingness to participate in future research and reluctance towards participation. Parents filled out a questionnaire on this topic. Symptomatic patients as well as healthy controls were analysed. Forty-one children were included. Children's anticipatory fear for future research showed a clear decrease of 0.7 ± 1.6 on a 5-point Likert scale as a consequence of participation (p = 0.02). Sixty percent of all participating children explicitly indicated willingness to undergo identical research procedures again. Children uninformed by their parents about the venipuncture were significantly more reluctant to the venipuncture after the procedure (p < 0.01), compared to children who had been informed (4.0 ± 0.9 resp. 2.8 ± 1.2).Conclusion: This study suggests that the emotional burden of participation in asthma research for underage children can be prevented when they are properly informed and decreases as a consequence of participations. We believe increased emphasis should be placed on informing children and evaluating the emotional impact of research to help caretakers and research ethics committees make informed decisions about participation of children in medical research. What is Known: • Medical professionals and parents are likely to overestimate children's discomfort undergoing (invasive) research procedures. • Two thirds of children (age 6-18 years) participating in medical research indicated that they would participate in the same research study again. What is New: • Pre-school children experience little emotional burden during invasive procedures in asthma research. • Proper communication about (invasive) research procedures in pre-school children helps to reduce the anticipatory fear of these procedures in the future.

Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children.

INTRODUCTION: Intravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress. METHODS AND ANALYSIS: This randomised controlled superiority trial will be conducted in a Canadian paediatric ED. We plan to recruit 80 patients. Children will be eligible if they (1) are 6 to 11 years of age, (2) need an IVI, (3) are fully conscious and alert, (4) have sufficient knowledge of the English language to understand and complete the study assessments and (5) are accompanied by a legal guardian. Our primary objective is to compare patient-reported pain and distress with the use of distraction (via a humanoid robot) versus standard care in children. The primary outcomes will be (1) self-reported pain, as measured by the Faces Pain Scale-Revised and (2) observed distress, as measured by the Observational Scale of Behavioural Distress-Revised. Secondary outcomes will include (1) measuring parental anxiety, (2) examining the association between parental anxiety and child outcomes and (3) children's degree of engagement with the humanoid robot via the Intrinsic Motivation Inventory tool. First enrolment occurred in April 2017 and is ongoing. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent to participate will be obtained from all participants' parents/guardian, in conjunction with assent from the participant themselves. This study data will be submitted for publication regardless of results. Purchase of the robot was facilitated through a Stollery Children's Hospital Foundation donation. Recruitment costs are supported by the Women and Children's Health Research Institute. TRIAL REGISTRATION NUMBER: NCT02997631; Pre-results.

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.