Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial.

OBJECTIVE: To assess whether music therapy (MT) is effective to reduce pain during daily personal hygiene care (DPHC), a procedure performed in all patients in a pediatric intensive care unit. METHODS: Fifty critically ill children were enrolled in a crossover controlled clinical trial with random ordering of the intervention, that is, passive MT, and standard conditions, and blind assessment of pain on film recordings. The primary outcome was variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during DPHC. Secondary outcomes were changes in heart rate, respiratory rate, and mean arterial blood pressure, and administration of analgesic or sedative drugs during DPHC. Mixed-effects linear model analysis was used to assess effect size (95% CI). RESULTS: The median (Q25-Q75) age and weight of the patients were 3.5 years (1.0-7.6 years) and 15.0 kg (10.0-26.8 kg). Consecutive DPHC were assessed on days 3 (2-5) and 4 (3-7) of hospitalization. In standard conditions, FLACC score was 0.0 (0.0-3.0) at baseline and 3.0 (1.0-5.5) during DPHC. With MT, these values were, respectively, 0.0 (0.0-1.0) and 2.0 (0.5-4.0). Rates of FLACC scores of >4 during DPHC, which indicates severe pain, were 42% in standard conditions and 17% with MT (P = .013). Mixed-effects model analysis found smaller increases in FLACC scores (-0.54 [-1.08 to -0.01]; P = .04) and heart rate (-9.00; [-14.53; -3.40]; P = .001) with MT. CONCLUSIONS: MT is effective to improve analgesia in critically ill children exposed to DPHC. TRIAL REGISTRATION: This study was recorded (April 16, 2019) before patient recruitment on the National Library of Medicine registry (NCT03916835; https://clinicaltrials.gov/ct2/show/NCT03916835).

Effects of parental holding on pain response in young children during cystometry: A randomized controlled trial.

INTRODUCTION: Cystometry is essential for evaluating bladder function. However, children may react negatively to the physical pain of urethral catheterization or anxiety and fear of an unfamiliar environment. These pain responses during the cystometry procedure may interfere with the cystometry procedure and make it difficult to interpret the cystometry result. In this regard, the International Children's Continence Society has advised performing cystometry while holding infants as an effective nonpharmacological pain management method, but there is insufficient evidence to support this. PURPOSE: This study aimed to analyze the effect of parental holding on reducing pain in children during cystometry. METHODS: This was an experimental study in a randomized controlled pre-post test design. A total of 64 participants aged 6-18 months were recruited. During cystometry, the participants in the experimental group were placed on the parent's laps and held in the parents' arms. The participants in the control group were laid down on the examination table. During the procedure, both groups of parents were allowed to touch their children in all ways except holding them and to use the pacifier if they wished. The behavioral (face, leg, activity, cry, consolability scale) and physiological (oxygen saturation and heart rate) pain responses were measured at three-time points (immediately, 3, and 10 min after urethral catheter insertion). RESULTS: Comparing the two groups, in the experimental group, the behavioral pain response at 3 min after urethral catheter insertion (t = -2.165, p = 0.034) and 10 min after (t = -3.155, p = 0.002) was decreased compared with that immediately after urethral catheter insertion. In addition, oxygen saturation increased more (t = 2.021, p = 0.048), and the heart rate decreased more (t = -2.033, p = 0.047) at 10 min than at 3 min after urethral catheter insertion in the experimental group. CONCLUSIONS: This study revealed that parental holding could reduce pain responses during cystometry in children. Further research is required to confirm the applicability and usefulness of parental holding during cystometry.

The effect of a cognitive behavioural intervention package on peripheral venous cannulation pain, fear and anxiety in Paediatric patients: A randomised controlled trial.

PURPOSE: This study investigated the effect of a cognitive behavioural intervention package (CBIP) on peripheral venous cannulation (PVC) pain, fear and anxiety in paediatric patients aged 7-12 years. DESIGN AND METHODS: This randomised controlled trial included 77 paediatric patients (intervention: n = 39 and control: n = 38). The control group underwent a routine PVC procedure, whereas the intervention group attended the CBIP while undergoing a PVC procedure. Data were collected using a sociodemographic form, the Visual Analogue Scale (VAS), the Wong-Baker FACES (WB-FACES) Pain Rating Scale, the Children's Fear Scale (CFS) and the State-Trait Anxiety Inventory for Children-State Form (STAIC-State). The participants, their caregivers and the researcher scored PVC pain, fear and anxiety levels. The study was approved by an ethics committee. Informed consent was obtained from caregivers, and verbal consent was obtained from children. RESULTS: No significant difference in pre-procedural CFS scores were noted between the CBIP and control groups (p > 0.05). However, the CBIP group had significantly lower mean procedural pain (VAS and WB-FACES), fear (CFS) and anxiety (STAIC-State) scores than the control group (p < 0.05). CONCLUSIONS: The CBIP helped children experience less PVC pain, fear and anxiety. PRACTICE IMPLICATIONS: Nurses can use the CBIP to help reduce PVC pain, fear and anxiety in children. CLINICAL TRIALS REGISTRATION: The study was registered at Clinical-Trials.gov (NCT06018909).

Effect of combining oral glucose solutions with supportive positions on pain during heel puncture blood sampling in premature infants: A randomized quadruple-blinded experimental study.

PURPOSE: The trial aimed to assess the impact on pain scores of the administration of oral glucose solutions at different concentrations and in combination with supportive positions during heel puncture procedures. DESIGN & METHODS: This trial was structured as a quadruple-blinded experimental study conducted at a single center - a Level II and IVa NICU between June 2022-2023. Included in the study were 128 premature infants born with a gestational age of between 33 and 36 weeks and a postnatal age of <7 days. For the heel puncture procedures, four distinct interventions were employed, each involving supportive positions and oral solutions. All interventions were recorded on video for analysis, and data were collected using the "Infant Information and Observation Form" and "Neonatal Pain, Agitation and Sedation Scale (N-PASS)". The N-PASS was rated by two independent nurses. The data were analyzed with the two-way repeated measures ANOVA and post-hoc Bonferroni tests. RESULTS: The descriptive and clinical characteristics were similar in all groups (p > 0.05). The pain scores, physiological variables and total crying times of the premature infants differed significantly depending on the interventional groups and times, and the interaction between the groups and times (p < 0.05). CONCLUSIONS: Combining glucose solutions with supportive positions led to a reduction in pain scores, a decrease in total crying time when compared to the use of supportive positions alone. PRACTICE IMPLICATIONS: Combining an oral 20% glucose solution with supportive positions can be recommended to reduce pain during unplanned heel puncture procedures in the absence of a parent in the unit.

The effects of white noise and swaddling methods on orogastric tube insertion-related pain in preterm infants: A randomized controlled trial.

AIM: This study aims to investigate the effects of the white noise, swaddling and white noise + swaddling methods on pain and physiological parameters associated with orogastric tube insertion procedure. METHODS: This was a randomized controlled trial. A total of 132 preterm infants were randomly assigned to four groups as white noise group (n = 33), swaddling group (n = 33), white noise + swaddling group (n = 33) and control group (n = 33). Interventions were initiated 5 min before the orogastric tube insertion procedure and continued during and up to 5 min after the procedure. RESULTS: White noise intervention alone did not have a significant effect on reducing pain associated with orogastric tube insertion (p > 0.05). Compared with the control group, the preterm infants in the swaddling group experienced 0.587 times less pain, and those in the white noise + swaddling group experienced 0.473 times less pain. CONCLUSIONS: Findings indicate the swaddling and the combination of white noise + swaddling may be a useful intervention in reducing the invasive pain experienced by preterm infants during and after orogastric tube insertion and in improving the physiological parameters associated with pain.

Parenting pain away: Quasi-experimental study of an eHealth learning platform to evaluate acceptability, feasibility, and utilisation of parent-led pain management.

AIM: To evaluate the impact of an eHealth educational resource about infant procedural pain management, given during the prenatal period, on feasibility, acceptability, knowledge, self-efficacy, and involvement. BACKGROUND: Routine health care requires newborns to have painful procedures (e.g., intramuscular injection). The impacts of untreated pain in neonates are widely recognised but adoption of effective procedural pain management strategies in clinical practice varies. There is clear evidence supporting the effectiveness of parent-led pain management during procedures (e.g., skin-to-skin care) and reputable resources to raise awareness among parents are warranted. Our team co-created Parenting Pain Away, a website to equip parents with evidence to assist with managing the pain of procedures and empower them to be involved. METHODS: A quasi-experimental evaluation using a pre/post intervention design with low-risk expectant parents. RESULTS: Of the 41 participants, before intervention exposure participants were familiar or had used skin-to-skin care (n = 33), breastfeeding (n = 30) and sucrose (n = 13) as pain management. Most participants (n = 38) desired more information on how to be involved. Providing access to Parenting Pain Away during pregnancy was supported and participants ranked the website above average using the System Usability Scale. Parenting Pain Away did not have a statistically significant influence on outcomes. Participants reported variation in clinical support with parent-led pain management. CONCLUSION: A multifaceted approach is recommended to maintain infant procedural pain management. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Equipping parents with knowledge related to infant pain management using an eHealth approach satisfied their information desires. The study findings are important considerations for perinatal care providers, policy makers, and families to finally achieve adequate procedural pain management. REPORTING METHOD: This study used the STROBE checklist, adhering to EQUATOR guidelines. PATIENT AND PUBLIC CONTRIBUTION: A stakeholder group (expectant parents, parents, perinatal researchers, clinicians, and administrators) was created to inform the study design and intervention.

Undergraduate dental students' perceptions of dental pain in children - A grounded theory study.

INTRODUCTION: There is an underuse of pain management strategies in dental care for children, possibly owing to perceived stress and discomfort when treating children, which has also been reported by dental students. The aim of this study was to explore how undergraduate dental students experience and understand pain related to dental treatment in children. MATERIALS AND METHODS: Interviews were held with 21 Swedish dental students, from 3 dental schools, all in their final 2 years of education. The interviews were transcribed verbatim and analysed according to Grounded Theory. RESULTS: A core category, seeking guidance to avoid pain, was identified and related to 6 conceptual categories. The students used different strategies to manage pain prevention in child dentistry and to become skilled dentists. They described high levels of stress, as well as having high expectations on themselves when treating children. The stress led to a surface learning approach, something the students were not fully aware of. CONCLUSION: All children should have the right to be ensured optimal pain prevention in dental care. The basis for this is laid during undergraduate education. Thus, pain management in child dentistry is an area in need of special attention in this respect. The academic staff has an important role in supporting their students in their process to gain an identity as professional dentists. To ensure that students incorporate an understanding of the importance of pain prevention when treating children there is a need to create more integration between theory and clinical training in undergraduate education.

Clinical efficacy and patients' perception of virtual reality during wound care in adults: A systematic review with meta-analysis of randomised clinical trials.

This study was aimed to review Virtual Reality's (VR) impact on pain, anxiety, opioid usage, physiological and behavioural responses, and patients' experience during wound care (WC) in adults. We searched multiple databases (Embase, Medline ALL, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, Scopus and Google Scholar) from inception until January 27th, 2023. Included studies compared VR alone or as an adjunct to standard WC with standard WC or other distraction methods, in adults with burn or non-burn-related wounds. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomised parallel-group and crossover trials. The review followed PRISMA guidelines for reporting. Fourteen studies were eligible for inclusion. The meta-analysis was limited to studies comprising solely of adult participants. VR reduced pain intensity compared to standard WC in all study designs. Despite not being included in the meta-analysis due to reasons such as mixed population or lack of sufficient statistical data, other studies showed significant pain reduction using VR. Additionally, VR improved patients' experience of WC. No clear effect was found on other outcomes including anxiety, opioid usage and physiological and behavioural responses. VR shows promise in reducing acute pain and enhancing patients' experience of WC. The observed variations in the effects of VR at group and individual levels indicate the need for a personalised treatment plan by selecting the right VR for the right patient given at the right time.

Clinical Hypnosis for Procedural Pain and Distress in Children: A Scoping Review.

OBJECTIVE: Pain and distress are common in children undergoing medical procedures, exposing them to acute and chronic biopsychosocial impairments if inadequately treated. Clinical hypnosis has emerged as a potentially beneficial treatment for children's procedural pain and distress due to evidence of effectiveness and potential superiority to other psychological interventions. However, systematic reviews of clinical hypnosis for children's procedural pain and distress have been predominantly conducted in children undergoing oncology and needle procedures and are lacking in broader pediatric contexts. This scoping review maps the evidence of clinical hypnosis for children's procedural pain and distress across broad pediatric contexts while highlighting knowledge gaps and areas requiring further investigation. METHODS: Published databases (PubMed, Cochrane Library, PsycINFO, Embase, CINAHL, Scopus, and Web of Science) and grey literature were searched in addition to hand-searching reference lists and key journals (up to May 2022). Two independent reviewers screened the titles and abstracts of search results followed by a full-text review against eligibility criteria. Articles were included if they involved a clinical hypnosis intervention comprising an induction followed by therapeutic suggestions for pain and distress in children undergoing medical procedures. This review followed the Arksey and O'Malley (2005) methodology and incorporated additional scoping review recommendations by the Joanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: A total of 38 eligible studies involving 2,205 children were included after 4,775 articles were screened. Research on clinical hypnosis for children's procedural pain and distress was marked by a lack of fidelity measures and qualitative data as well as by inadequate intervention reporting and high attrition rates. Evidence regarding the safety of clinical hypnosis, pain unpleasantness outcomes, factors influencing outcomes, as well as barriers and facilitators to implementing hypnosis and study procedures was also lacking. Clinical hypnosis has potential benefits for children's procedural pain and distress based on evidence of superiority to control conditions and nonpharmacological interventions (e.g., distraction, acupressure) with moderate to large effect sizes as reported in 76% of studies. However, heterogeneous interventions, contexts, study designs, and populations were identified, and the certainty of the evidence was not evaluated. CONCLUSIONS: The review suggests potential benefits of clinical hypnosis for children's procedural pain and distress and thus provides a precursor for further systematic reviews and trials investigating the effectiveness of clinical hypnosis. The review also indicates the need to further explore the feasibility, acceptability, implementation, and safety of clinical hypnosis in children undergoing painful procedures. Based on the review, researchers implementing clinical hypnosis should adequately report interventions or use treatment manuals, follow recommended research guidelines, and assess the fidelity of intervention delivery to promote replicating and comparing interventions. The review also highlights common methodological shortcomings of published trials to avoid, such as the lack of implementation frameworks, small sample sizes, inadequate reporting of standard care or control conditions, and limited evidence on pain unpleasantness outcomes.

Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial.

The objective of this study is to assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 and 5 years undergoing painful injection procedures in an outpatient setting. We carried out a randomized, unmasked clinical trial in children undergoing venipuncture or intramuscular injection procedures. Patients were randomized to a distraction virtual reality video or standard care. After the procedure, three independent observers (parents, researchers, nursing staff) rated pain on the LLANTO pain scale. We recruited 122 subjects, half of which were randomized to virtual reality. The median age was of approximately 60 months (IQR: 15 months), and the sample was balanced with regard to sex. There were significant differences in LLANTO scales scores between the VR subjects and controls of - 3.34 (95% CI - 4.15; - 2.54), - 3.02 (95% CI - 3.90; - 2.14), and - 2.98 (95% CI - 3.87; - 2.09), as rated by parents, researchers, and nursing staff, respectively. Agreement between raters was high for all three types of observers, with Cohen Kappas over 0.79 in all cases. Bivariate analysis showed reductions in the risk of obtaining higher scores in the LLANTO scale. Linear regression models showed a reduction of approximately 3 points in the scale, regardless of the type of observer. These models were adjusted for sex, age, kind of procedure, use of prior analgesia, and recruitment center. CONCLUSIONS: Non-immersive virtual reality is an effective adjunctive therapy for the reduction of pain in children undergoing painful injection procedures in an outpatient setting. This strategy may be used to improve the quality of care in pediatric outpatient services. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03985930 (Registered June 14, 2019). WHAT IS KNOWN: •The use of immersive virtual reality (VR) has been described as an effective adjunctive distraction method during painful procedures in children over 5 years. WHAT IS NEW: •The utility of non-immersive VR in children below that age is not yet clear. This randomized clinical trial comparing non-immersive VR vs. standard care showed an average reduction of three points in the LLANTO pain scale favoring non-immersive VR. Non-immersive VR is an effective and inexpensive non-pharmacological technique that reduces fear and pain in pediatric patients.

Low-dose intranasal dexmedetomidine premedication improves epidural labor analgesia onset and reduces procedural pain on epidural puncture: a prospective randomized double-blind clinical study.

BACKGROUND: Epidural labor analgesia is a safe and effective method of pain management during labor with the drawbacks of delayed onset and maternal distress during epidural puncture. This study aimed to determine whether pretreatment with intranasal low-dose dexmedetomidine effectively shortens the onset of analgesia and reduces procedural pain. METHODS: In this prospective, randomized double-blind trial, nulliparous patients were randomly assigned to either the intranasal dexmedetomidine group or the control group. The intranasal dexmedetomidine group received 0.5 µg/kg dexmedetomidine intranasally, and the control group received an equal volume of normal saline intranasally. Both groups were maintained with a programmed intermittent epidural bolus. The primary outcome was the onset time of analgesia and scores of pain related to the epidural puncture. RESULTS: Seventy-nine patients were enrolled, and 60 completed the study and were included in the analysis. The time to achieve adequate analgesia was significantly shorter in the intranasal dexmedetomidine group than in the control group (hazard ratio = 2.069; 95% CI, 2.187 to 3.606; P = 0.010). The visual analogue scale pain scores during epidural puncture in the intranasal dexmedetomidine group were also significantly lower than those in the control group (2.0 (1.8-2.5) vs. 3.5 (3.3-4.5), P ≤ 0.001, Table 2). Pretreatment with intranasal dexmedetomidine before epidural labor analgesia was associated with improved visual analogue scale pain scores and Ramsay scores, less consumption of analgesics and higher maternal satisfaction (P < 0.05). No differences were observed for labor and neonatal outcomes or the incidence of adverse effects between the two groups. CONCLUSIONS: Pretreatment with intranasal dexmedetomidine before epidural labor analgesia yielded a faster onset of analgesia and decreased epidural puncture pain without increasing adverse effects. Pretreatment with intranasal dexmedetomidine may be a useful adjunct for the initiation of epidural analgesia, and further investigation should be encouraged to determine its utility more fully. TRIAL REGISTRATION: This trial was prospectively registered at Chictr.org.cn on 29/05/2020 with the registration number ChiCTR2000033356 ( http://www.chictr.org.cn/listbycreater.aspx ).

Minor painful procedures in extremely preterm infants admitted to a tertiary neonatal intensive care unit: Opportunities to improve pain mitigation.

AIM: This study aims to characterise current pain management practices in extremely preterm infants (gestational age less than or equal to 28 weeks) admitted to neonatal intensive care unit (NICU). METHODS: Retrospective audit pertaining to patient characteristics, as well as minor painful procedures (MPP), pain mitigation and pain scoring in 25 extremely preterm infants admitted to a tertiary NICU in 2016 over the first 14 days of NICU admission. Opportunities to bundle MPP were identified according to pre-specified criteria. Bayley Scales of Infant Development, Third Edition (BSID-III) cognitive, language and motor composite scores were available from the neurodevelopmental follow-up clinic at 12- and 24-months of corrected age. Linear mixed methods regression was used to examine for correlation between increased exposure to MPP and BSID-III scores at follow-up. RESULTS: Extremely preterm infants underwent an average of 11.24 ± 4.12 MPP per day for the first 14 days of NICU admission. Opportunities to bundle MPP were missed 75.98% (408/537) of the time; most of these were invasive blood collections. A total of 12.2% (481/3933) of MPP occurred within 4 h of pharmacological or non-pharmacological pain mitigation. BSID-III motor composite score was associated with an 11.75 (95% confidence interval 1.99, 21.27) decrease in patients experiencing more than or equal to the third quartile of MPP in the 14 days post-NICU admission (P = 0.0329, n = 42). Association was not found for BSID-III cognitive and language composite scores. CONCLUSIONS: There is readily scope for quality improvement initiatives to reduce harm in extremely preterm infants admitted to NICU.

Development, evaluation and adaptation of a critical realism informed theory of procedural pain management in preterm infants: The PAIN-Neo theory.

AIM: To present the development, evaluation and adaptation of the PAIN-Neo theory. DESIGN: Theory development. DATA SOURCES: A review of literature was conduct from 1980 to 2021. RESULTS: Using a critical realism paradigm, this paper presents the PAIN-Neo theory, which was developed from an analysis of existing theoretical perspectives on paediatric procedural pain, empirical studies conducted with preterm infants, and the research team's pain management expertise. The theory was then empirically tested and fine-tuned. IMPLICATIONS FOR NURSING: The PAIN-Neo theory highlights that the neonatal nurse is part of a larger picture as she is influenced by factors related to her unit, hospital and country of practice. This theory emphasizes the importance of parental involvement in pain management, which is consistent with family-centred nursing practices. CONCLUSION: The PAIN-Neo theory reflects the complexity of pain management nursing. This theory is innovative and specific enough to guide practice, structure research projects and contribute to the body of knowledge in the discipline of nursing.

Investigation of pain associated with endotracheal aspiration and affecting factors in an intensive care setting: A prospective observational study.

BACKGROUND: Endotracheal aspiration is a painful nociceptive procedure. There is still a gap in the literature on studies to determine the pain level and nursing interventions for aspiration. OBJECTIVES: This study evaluated pain during endotracheal aspiration and examined the factors affecting pain. METHODS: This prospective observational study was conducted with 105 inpatients meeting the inclusion criteria in the internal intensive care unit of a public hospital. Two hundred ten aspiration procedures were monitored for pain and other variables. ASPMN 2019 Position Statement recommendations were followed in designing the study and determining the procedure. The pain score range obtained from The Critical Care Pain Observation Tool was 0-8. A score of 2 or more is considered to indicate the presence of pain. The primary outcome measures were pain associated with endotracheal aspiration and affecting factors in this study. The generalised linear mixed model established for aspiration procedure-associated pain and affecting factors was analysed. RESULTS: Patients' mean pain score was 1.24 ± 2.05 before, 3.07 ± 2.17 during, and 2.35 ± 1.94 after aspiration and 0.89 ± 1.40 at 15 min after aspiration. The pain rate was 26.1% before, 71% during, and 60.9% after the aspiration procedure and 18.8% after 15 min. There was a statistically significant difference between all pain scores evaluated. The difference in aspiration-related pain scores by age, respiratory diseases, sedation status, aspiration pressure, and tube diameter was statistically significant. CONCLUSIONS: The pain score due to aspiration procedure increased significantly in intensive care unit inpatients and is an important risk factor for patient safety. More focus is needed on the causes and measures of aspiration-related pain.

The impact of music, play, and pet therapies in managing pain and anxiety in paediatric patients in hospital: a rapid systematic review.

Background: Hospitalized children face pain and anxiety associated with the environment and procedures. Objective: This review aimed to assess the impact of music, play, pet and art therapies on pain and anxiety in hospitalized paediatric patients. RCTs assessing the impact of music, play, pet, and/or art therapies on pain and/or anxiety in hospitalized paediatric patients were eligible. Methods: Database searching and citation screening was completed to identify studies. A narrative synthesis was used to summarize study findings and certainty of evidence was assessed using GRADE. Of the 761 documents identified, 29 were included spanning music (n = 15), play (n = 12), and pet (n = 3) therapies. Results: A high certainty of evidence supported play in reducing pain and moderate certainty for music and pet. A moderate certainty of evidence supported music and play in reducing anxiety. Conclusion: Complementary therapies utilized alongside conventional medical treatment may mitigate pain and anxiety in hospitalized paediatric patients.

The Impact of Parental Presence on Their Children During Painful Medical Procedures: A Systematic Review.

OBJECTIVE: Whether parental presence during their children's painful medical procedures is advantageous with regard to children's pain-related outcomes is questionable. Research on this topic is equivocal, and additional questions, such as whether levels of parental involvement may play a role as well, remain to be addressed. The purpose of this systematic review is to summarize and critically appraise the literature on the impact of parental presence vs absence during their children's painful medical procedures on the child's pain-related outcomes. METHODS: The review protocol was registered on Prospero (ID CRD42018116614). A systematic search in PubMed, Web of Science, and PsycArticles resulted in 22 eligible studies incorporating 2,157 participants. Studies were considered eligible if they included children (≤18 years old) undergoing a painful medical procedure and compared parental presence and/or involvement with parental absence during the procedure. RESULTS: The children's pain-related outcomes included self-reported pain intensity, self-reported fear, anxiety and distress, observed pain-related behavior, and physiological parameters. Overall, evidence points in the direction of beneficial effects of parental presence vs absence with regard to children's self-reported pain intensity and physiological parameters, whereas mixed findings were recorded for children's self-reported fears, anxiety and distress, and observed pain-related behaviors. CONCLUSIONS: To provide clear recommendations on how to involve the parent during the procedure, as well as for which type of children and parents parental presence has the best effects, further research is needed, as indicated in this review.

Clown therapy for procedural pain in children: a systematic review and meta-analysis.

Among the distraction techniques used for the non-pharmacological management of acute pediatric pain, one of the most performed is clown therapy. Despite the presence in the literature of some systematic reviews that evaluate its effectiveness, none of them examines its outcomes on procedural pain which has therefore been investigated in this study. The literature search for randomized controlled trials (RCTs) was performed on the Cochrane Library, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, and Scopus over a time frame ranging from each database setup date to 31 July 2021. The primary outcome was the procedural pain of children. We used the Cochrane Risk of Bias tool to assess the risk of bias of the included studies. Six RCTs were selected for this review, which included a total of 517 pediatric subjects. Children undergoing clown therapy during the venipuncture or peripheral vein cannulation procedure reported less pain than those exposed to the standard of care (SMD = -0.55; 95% CI: -1.23, 0.13) but the result was not found to be statistically significant. School-aged children and adolescent reported significantly less pain (SMD = -0.51; 95% CI: -0.92, -0.09). Compared to the standard of care, children's anxiety was significantly lower with clown therapy (SMD = -0.97; 95% CI: -1.38, -0.56). CONCLUSION: Clown therapy seems effective in reducing procedural pain in children, particularly for older age groups, but due to poor methodological quality and the high risk of bias of the studies included, the results obtained should be considered with caution. WHAT IS KNOWN: • Clown therapy is one of the most used techniques in the non-pharmacological management of acute pediatric pain. • Laughter physiologically stimulates the production of beta-endorphins, substances with an effect similar to opiates. WHAT IS NEW: • Clown therapy seems effective in reducing procedural pain and anxiety in children. • The intervention in school-age children or adolescents produces a statistically significant decrease in the symptom.

A randomized controlled trial on virtual reality distraction during venous cannulation in young children.

BACKGROUND AND OBJECTIVES: Pain management in children is often inadequate, and the single most common painful procedure in children who are hospitalized is needle procedures. Virtual reality (VR) has been shown to decrease anxiety and pain in children undergoing painful procedures primarily in children from the age of 7 years. Our aim for this study is to investigate patient satisfaction and pain reduction by using a three-dimensional VR interactive game as a distraction in 4-7 years old children during venous cannulation. METHODS: In this randomized clinical trial, we enrolled 106 children aged 4-7 years who were scheduled for venous cannulation. Patients assigned to the control group were adherent to standard of care, including topical numbing cream, positioning, and distraction in this group by games of choice on a tablet/smartphone. In the study group, children were adherent to standard of care and were distracted by an interactive VR game. Primary outcomes were patient satisfaction and the procedural pain assessed by using Wong-Baker Faces Pain Rating Scale; secondary outcomes were the procedural time and any adverse events. RESULTS: We found an overall high level of patient satisfaction with our regime of topical numbing cream, positioning, and distraction. The primary outcome of pain during the procedure was median 20 mm (IQR 0-40) and 20 mm (IQR 0-55) (Wong-Baker 0-100 mm) in the VR group and the control group, respectively (difference: 0 mm, 95%CI: 0-20, p = .19). No significant difference was found in procedural times. The number of adverse effects was low, with no significant difference between the two groups. CONCLUSIONS: VR distraction is an acceptable form of distraction for children 4-7 years old when combined with topical numbing cream and positioning during preoperative venous cannulation. No difference was found between VR- and smartphone/tablet distraction.

Procedural Aspects of Epidural Catheter Placement: A Prospective Observational Study of 173 Epidural Catheter Insertions.

OBJECTIVE: The risks and benefits of epidural analgesia have been studied extensively, but information regarding many other aspects of epidural catheter insertion is limited. The authors aimed to add information regarding procedural pain, procedure duration, failure rates, and the effect of experience to the ongoing discussion on this procedure. DESIGN: A prospective observational study. SETTING: A Danish tertiary hospital. PARTICIPANTS: Patients scheduled to undergo video-assisted thoracic surgery. INTERVENTIONS: Epidural catheter insertion in 173 patients undergoing video-assisted thoracic surgery for lung cancer. MEASUREMENTS AND MAIN RESULTS: The authors recorded the time required for the epidural insertion procedure, the attempts used, insertion level, access use, patient position, placement technique used, and the designation of the physician placing the catheter. Furthermore, the authors asked the patients to evaluate the expected procedural pain, and after the procedure the authors asked them to evaluate the actual level of pain experienced. Six and 24 months after discharge, the authors examined persistent sequelae by using questionnaire assessments. The median procedure duration was 13 minutes, with 75% of the catheters placed within 22 minutes. Actual procedure-related pain (mean score [M] = 3.5, SD = 2.0) was significantly (p < 0.0001) less than that expected before the procedure (M = 4.9, SD = 2.0). The patients' expected pain, attempts required for successful catheter placement, and approach used to access the epidural space significantly affected the actual procedure-related pain (p = 0.001, p ≤ 0.003, and p = 0.023, respectively). Persistent pain and sensory disturbances were observed in 11% and 4% of the patients, respectively, after 6 months and in 6% and 4% of the patients, respectively, after 2 years. CONCLUSIONS: In this study, the authors examined several lesser-known aspects of epidural procedures. The use of epidural analgesia as part of the pain management plan after surgery requires a more complex evaluation instead of merely discussing the possibility of procedural infections, hematomas, or neurologic injuries. The procedure time, patients' expected and experienced pain related to the procedure, and the potential long-term side effects should be a part of the decision-making process.

Effects of Distraction on Reducing Pain During Invasive Procedures in Children with Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: Distraction is a known behavioral intervention that is widely used for pain management in the pediatric population. However, there is a shortage of reviews reporting the efficacy of distraction for procedural pain reduction in pediatric oncology settings. AIM: To determine the current evidence on the effects of distraction on procedural pain in children with cancer. DESIGN: This systematic review and meta-analysis was undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines SETTINGS: Six different databases from 1990 to June 2019. METHOD: A literature search was conducted to identify the effects of distraction on procedural pain reduction in children with cancer. A meta-analysis was undertaken along with applying a mixed effect model to quantify the standardized mean difference in the 95% confidence interval (CI) as the overall effects. RESULTS: Ten randomized controlled trials were included. Distraction during an invasive procedure had a large effect on pain intensity (-0.92, 95% CI -1.48 to -0.36, p = .001) and on needle insertion as well (-1.12, 95% CI -1.52 to -0.72, p = .000), but only a moderate effect on lumbar puncture procedures (-0.57, 95% CI -1.02 to -0.12, p = .012). Uncertain effects on pain relief showed up in a virtual reality (VR) distraction (-0.93, 95% CI -2.63 to 0.76, p = .28) and during active distraction (-0.72, 95% CI -1.48 to 0.03, p = .06). CONCLUSIONS: Distraction is an efficacious intervention to reduce procedural pain during needle insertion or lumbar puncture procedures in children with cancer. However, the efficacy of active distraction and VR remain uncertain. Future research should focus on specific comparisons of different forms of distractions with larger sample sizes.