Toward integrated pediatric medicine: Key learnings from the pediatric integrative medicine trial.

OBJECTIVE: The purpose of this study is to explore the facilitators to integrating complementary therapies in conventional pediatric hospital practice based on the experiences of parents, healthcare providers, and complementary therapy providers. DESIGN: This study is part of a larger research study that examined the introduction of a pediatric integrative medicine service in an acute care children's hospital in Canada. A qualitative descriptive study was conducted using semi-structured one-on-one telephone and in-person interviews with a sample of parents of children, as well as healthcare providers and complementary therapy providers. RESULTS: A total of 50 individuals, from key-stakeholder groups, were interviewed between May 2014 and January 2016. This study identified the following facilitators for the integration of complementary therapies within conventional care: 1) stakeholders' open-mindedness and familiarity with care practices outside of their experiences; 2) stakeholders' open communication, respect for eachothers' roles in the process of care, and appreciation for the role of complementary therapies within conventional medicine; and 3) stakeholders' receptiveness to redefining the meaning of a 'positive outcome' in the context of hospital care. CONCLUSION: The findings of this study demonstrate that some of the existing barriers to the integration of complementary therapies in conventional hospital care could be mediated by creating an environment where the fundamental value of commitment to patient wellbeing is equally shared by all stakeholders.

A randomized trial of iPad distraction to reduce children's pain and distress during intravenous cannulation in the paediatric emergency department.

OBJECTIVES: We compared the addition of iPad distraction to standard care, versus standard care alone, to manage the pain and distress of intravenous (IV) cannulation. METHODS: Eighty-five children aged 6 to 11 years requiring IV cannulation (without child life services present) were recruited for a randomized controlled trial from a paediatric emergency department. Primary outcomes were self-reported pain (Faces Pain Scale-Revised [FPS-R]) and distress (Observational Scale of Behavioral Distress-Revised [OSBD-R]), analyzed with two-sample t-tests, Mann-Whitney U-tests, and regression analysis. RESULTS: Forty-two children received iPad distraction and 43 standard care; forty (95%) and 35 (81%) received topical anesthesia, respectively (P=0.09). There was no significant difference in procedural pain using an iPad (median [interquartile range]: 2.0 [0.0, 6.0]) in addition to standard care (2.0 [2.0, 6.0]) (P=0.35). There was no significant change from baseline behavioural distress using an iPad (mean ± SD: 0.53 ± 1.19) in addition to standard care (0.43 ± 1.56) (P=0.44). Less total behavioural distress was associated with having prior emergency department visits (odds ratio [95% confidence interval]: -1.90 [-3.37, -0.43]) or being discharged home (-1.78 [-3.04, -0.52]); prior hospitalization was associated with greater distress (1.29 [0.09, 2.49]). Significantly more parents wished to have the same approach in the future in the iPad arm (41 of 41, 100%) compared to standard care (36 of 42, 86%) (P=0.03). CONCLUSIONS: iPad distraction during IV cannulation in school-aged children was not associated with less pain or distress than standard care alone. The effects of iPad distraction may have been blunted by topical anesthetic cream usage. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT02326623.

Comparative Effectiveness of Pediatric Integrative Medicine: A Pragmatic Cluster-Controlled Trial.

Symptoms of pain, nausea/vomiting, and anxiety (PNVA) are highly prevalent in pediatric inpatients. Poorly managed symptoms can lead to decreased compliance with care, and prolonged recovery times. Pharmacotherapy used to manage PNVA symptoms is of variable effectiveness and carries safety risks. Complementary therapies to manage these symptoms are gaining popularity due to their perceived benefits and low risk of harm. Pediatric integrative medicine (PIM) is the combination of complementary therapies with conventional medicine in pediatric populations. A two-arm, cluster-controlled, pragmatic clinical trial was carried out to compare the effectiveness of a PIM service in conjunction with usual care, versus usual care only to treat PNVA symptoms in hospitalized pediatric patients. The primary outcome was the improvement of PNVA symptom severity using a 10-point numerical rating scale. Participant enrollment occurred between January 2013 and January 2016. A total of 872 participants (usual care n = 497; PIM n = 375) were enrolled. The PIM therapies significantly reduced PNVA symptom severity (p < 0.001). This study found that a hospital-based PIM service is both safe and effective for alleviating PNVA symptoms. Future research should carry out this work in other pediatric inpatient divisions, and in other sites to determine the reproducibility of findings.

A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department.

OBJECTIVES: Our objectives were to evaluate the effectiveness of humanoid robot-based distraction on reducing distress and pain in children undergoing intravenous insertion. METHODS: A two-arm, open-label randomized controlled trial was conducted April 2017-May 2018, in a pediatric emergency department (ED). A sample of 86 children aged 6-11 years who required intravenous insertion were recruited. Exclusion criteria included hearing/visual impairments, neurocognitive delay, sensory impairment to pain, previous enrollment, and ED clinical staff discretion. Outcome measures included the Observed Scale of Behavioral Distress-Revised (OSBD-R) (distress) and the Faces Pain Scale-Revised (FPS-R) (pain). RESULTS: Of the 86 children recruited (median age 9 years, IQR 7,10); 55% (47/86) were male, 9% (7/82) were premature, 82% (67/82) had a previous ED visit, 31% (25/82) had a previous hospitalization and 78% (64/82) had previous intravenous insertion. Ninety-six percent (78/81) received topical anesthetic prior to intravenous insertion. Total OSBD-R distress score was 1.49 ± 2.36 (standard care) versus 0.78 ± 1.32 (robot) (p < 0.05). FPS-R pain score was 4 (IQR 2,6) (standard care) versus 2 (IQR 0,4) (robot) (p = 0.13). Parental anxiety immediately after the procedure was 36.7 (11.1) (standard care) versus 31.3 (8.5) (robot) (p = 0.04). Parents were more satisfied with pain management in the robotic distraction group (95% vs 72% very satisfied) (p = 0.002). CONCLUSIONS: Humanoid robot-based distraction therapy is associated with a modest positive impact on child distress for pediatric intravenous insertion, but not pain. It can be considered a potential tool in the ED toolkit for procedural pain-associated distress reduction. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02997631.

RéSUMé: OBJECTIFS: Nos objectifs étaient d'évaluer l'efficacité de la distraction robotique humanoïde pour réduire la détresse et la douleur chez les enfants subissant une insertion intraveineuse. MéTHODES: Un essai contrôlé randomisé ouvert à deux bras a été mené d'avril 2017 à mai 2018, dans un service d'urgence pédiatrique. Un échantillon de 86 enfants âgés de 6 à 11 ans ayant besoin d'une insertion intraveineuse a été recruté. Les critères d'exclusion comprenaient des déficiences auditives / visuelles, un retard neurocognitif, une déficience sensorielle de la douleur, une inscription antérieure et la discrétion du personnel clinique des urgences. Les mesures des résultats comprenaient l'échelle d'hétéro-évaluation comportementale (OSBD-R: Observational Scale of Behavioral Distress ­ Revised) (détresse) et l'échelle de visages (FPS-R: Faces Pain Scale-Revised) (douleur). RéSULTATS: Sur les 86 enfants recrutés (âge médian 9 ans, IQR 7,10) ; 55 % (47/86) étaient de sexe masculin, 9 % (7/82) étaient prématurés, 82 % (67/82) avaient une visite antérieure aux urgences, 31 % (25/82) avaient déjà été hospitalisés et 78 % (64/82) avaient déjà été insérés par voie intraveineuse. Quatre-vingt-seize pour cent (78/81) ont reçu une anesthésie topique avant l'insertion intraveineuse. Le score total de détresse OSBD-R était de 1,49 ± 2,36 (soins standard) contre 0,78 ± 1,32 (robot) (p < 0,05). Le score de douleur FPS-R était de 4 (IQR 2,6) (soins standard) contre 2 (IQR 0, 4) (robot) (p=0,13). L'anxiété parentale immédiatement après l'intervention était de 36,7 (11,1) (soins standard) contre 31,3 (8,5) (robot) (p=0,04). Les parents étaient plus satisfaits de la gestion de la douleur dans le groupe de distraction robotique (95 % vs 72 % très satisfaits) (p = 0,002). CONCLUSIONS: La thérapie de distraction à base de robot humanoïde est associée à un impact positif modeste sur la détresse de l'enfant pour l'insertion intraveineuse pédiatrique, mais pas la douleur. Il peut être considéré comme un outil potentiel dans la boîte à outils des Services d'Urgences pour la réduction de la détresse associée à la douleur procédurale.

Massage therapy for paediatric procedural pain: A rapid review.

BACKGROUND: Pain is a common paediatric problem, and procedural pain, in particular, can be difficult to manage. Complementary therapies are often sought for pain management, including massage therapy (MT). We assessed the evidence for use of MT for acute procedural pain management in children. METHODS: We searched five main databases for (i) primary studies in English, (ii) included children 0 to 18 years of age, (iii) compared MT for procedural pain management to standard care alone or placebo, and (iv) measured pain as the primary or secondary outcome. The data were extracted by one author and verified by a second author. Randomized controlled trials were evaluated using the Cochrane Risk of Bias tool. RESULTS: Eleven paediatric trials of procedural pain in neonatal, burn, and oncology populations, a total of 771 participants, were identified. Eight reported statistically significant reductions in pain after MT compared to standard care. Pain was measured using validated pain scales, or physiologic indicators. The studies were heterogeneous in population, techniques, and outcome measures used. No adverse events associated with MT were identified. CONCLUSION: MT may be an effective nonpharmacologic adjunct for management of procedural pain in children.

Music Use for Sedation in Critically ill Children (MUSiCC trial): a pilot randomized controlled trial.

OBJECTIVE: To demonstrate feasibility of a music medicine intervention trial in pediatric intensive care and to obtain information on sedation and analgesia dose variation to plan a larger trial. MATERIAL AND METHODS: Pilot randomized controlled trial (RCT) was conducted at the Stollery Children's Hospital general and cardiac intensive care units (PICU/PCICU). The study included children 1 month to 16 years of age on mechanical ventilation and receiving sedation drugs. Patients were randomized in a 1:1:1 ratio to music, noise cancellation or control. The music group received classical music for 30 min three times/day using headphones. The noise cancellation group received the same intervention but with no music. The control group received usual care. RESULTS: A total of 60 patients were included. Average enrollment rate was 4.8 patients/month, with a consent rate of 69%. Protocol adherence was achieved with patients receiving > 80% of the interventions. Overall mean (SD) daily Sedation Intensity Score was 52.4 (30.3) with a mean (SD) sedation frequency of 9.75 (7.21) PRN doses per day. There was a small but statistically significant decrease in heart rate at the beginning of the music intervention. There were no study related adverse events. Eighty-eight percent of the parents thought the headphones were comfortable; 73% described their child more settled during the intervention. CONCLUSIONS: This pilot RCT has demonstrated the feasibility of a music medicine intervention in critically ill children. The study has also provided the necessary information to plan a larger trial.

A caregiver, an expert, a patient: How complementary therapies support the roles of parents of children with life threatening conditions in hospital settings.

OBJECTIVE: The purpose of this study was to understand emerging roles of parents of hospitalized children with life threatening conditions and to explore how complementary therapies integrated into conventional pediatric care may shift and/or support these roles. DESIGN: This study is part of a larger research study that examined the introduction of a pediatric integrative medicine service at an acute care children's hospital in Canada. A qualitative descriptive study was conducted using one-on-one telephone interviews with a sample of parents of children included in the larger study. Children had access to complementary therapies including Reiki, massage therapy, and acupuncture. RESULTS: A total of 36 interviews were conducted between May 2014 and January 2016. This study found that parents of hospitalized children assume complex roles including that of caregiver, expert and patient (due to high levels of stress and anxiety). Moreover, the study reveals that the integration of complementary therapies with conventional care supports these parental roles. CONCLUSION: This study reveals that complementary therapies, introduced as a part of integrated approach to pediatric hospital care, and aimed primarily at managing distressing symptoms in patients, had simultaneously a positive contribution in providing parents with the means to navigate the complexities of parenting in the pediatric oncology and cardiology hospital wards and addressing some of their own needs.

Adverse events associated with paediatric massage therapy: a systematic review.

INTRODUCTION: Massage therapy (MT) is frequently used in children. No study has systematically assessed its safety in children and adolescents. We systematically review adverse events (AEs) associated with paediatric MT. METHODS: We searched seven electronic databases from inception to December 2018. We included studies if they (1) were primary studies published in a peer-reviewed journal, (2) involved children aged 0-18 years and (3) a type of MT was used for any indication. No restriction was applied to language, year of publication and study design. AEs were classified based on their severity and association to the intervention. RESULTS: Literature searches identified 12 286 citations, of which 938 citations were retrieved for full-text evaluation and 60 studies were included. In the included studies, 31 (51.6%) did not report any information on AEs, 13 (21.6%) reported that no AE occurred and 16 studies (26.6%) reported at least one AE after MT. There were 20 mild events (grade 1) that resolved with minimal intervention, 26 moderate events (grades 2-3) that required medical intervention, and 18 cases of severe AEs (grades 4-5) that resulted in hospital admission or prolongation of hospital stay; of these, 17 AEs were volvulus in premature infants, four of which were ultimately fatal events. CONCLUSION: We identified a range of AEs associated with MT use, from mild to severe. Unfortunately, the majority of included studies did not report if an AE occurred or not, leading to publication bias. This review reports an association between abdominal massage with volvulus without malrotation in preterm infants; it is still to be defined if this is casual or not, but our findings warrant caution in the use of abdominal massage in preterm infants.

Effectiveness of probiotics in infantile colic: A rapid review.

BACKGROUND: Infantile colic (IC) is a troubling condition with limited treatment options for young infants. This rapid review aims to synthesize the evidence for probiotics in the treatment and prevention of IC in healthy term infants. METHODS: We searched in MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews for systematic reviews (SRs), and randomized control trials (RCTs) published between January 1, 2000 and July 11, 2018. Trials were included if they recruited healthy full-term infants who received probiotics for treatment or prevention of colic. The quality of evidence was assessed using GRADE criteria. As supplementary information, the safety of probiotics in infants was searched within the reviewed studies and other recent publications. RESULTS: We identified four SRs and meta-analyses that included six RCTs, and found an additional three RCTs evaluating probiotics for the treatment of IC. One SR and six RCTs were identified for prevention of IC; four of the RCTs were included in the SR and two were published later. The probiotic Lactobacillus reuteri was used in the majority (five of eight) of treatment trials, and was found to significantly reduce crying in colicky breast-fed infants compared to placebo. Only two of the six prevention trials showed a significant decrease in crying time compared to placebo, although another two trials showed other benefits of probiotics, including reduced use of medications (simethicone and cimetropium bromide) and physician visits. No adverse events were identified in the included studies; other research suggests probiotics are generally safe in healthy children. CONCLUSION: This rapid review identified limited but favourable evidence of benefit of using probiotics for the treatment of IC in full-term breast-fed infants. While routine use of probiotics for treating or preventing IC cannot yet be recommended, it can be an option to manage IC.

Music Use for Sedation in Critically ill Children (MUSiCC trial): study protocol for a pilot randomized controlled trial.

BACKGROUND: Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied. METHODS: The Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children. DISCUSSION: Despite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.

Probiotics for paediatric functional abdominal pain disorders: A rapid review.

BACKGROUND: Functional abdominal pain disorders (FAPD) are prevalent in the paediatric population, however, there is currently no consensus regarding best practices for treatment. The use of probiotics is becoming popular to treat FAPD. The goal of this rapid review is to synthesize the best evidence on the use of probiotics in children with FAPD. METHODS: Searches were conducted on five main databases. Randomized controlled trials (RCTs) of probiotic use in children (0 to 18 years) with FAPD were searched. Populations of interest were patients with functional abdominal pain (FAP), irritable bowel syndrome (IBS), and functional dyspepsia (FD), recruited based on Rome criteria. Outcomes of interest were changes in abdominal pain severity, frequency, and duration. FINDINGS: Eleven RCTs with 829 participants with the diagnosis of FAP (n=400), IBS (n=329), FD (n=45), and mixed population (n=55) were included. Of six studies of children with FAP, two (n=103) used Lactobacillus rhamnosus GG (LGG) and reported no significant effects on pain, and four (n=281) used Lactobacillus (L) reuteri DSM 17938, of which three (n=229) reported significant positive effects on either severity or frequency of pain. Of six trials of children with IBS, four (n=219) used LGG, of which three (n=168) reported a positive effect. One (n=48) used bifidobacteria and one used VSL #3 (n=59), both demonstrating positive effects with probiotics. Two studies of FD reported no benefit. No adverse events were attributed to probiotics. CONCLUSIONS: There is preliminary evidence for use of probiotics, particularly LGG, in reducing abdominal pain in children with IBS. There are inconsistent positive effects of other probiotics, including L. reuteri DSM 17938, in reducing pain in patients with FAP, IBS, or FD. More RCTs with rigorous methodology using single or combination probiotics are warranted.

Parents' experiences of an inpatient pediatric integrative medicine service for symptom management.

BACKGROUND: Pediatric integrative medicine (PIM) refers to the combination of treatments from conventional medicine and complementary therapies for which there is evidence of safety and effectiveness. As pediatric use of complementary therapies increases, it is important to determine parental views on the use of these therapies by their children. OBJECTIVE: To describe parental experiences with a PIM service for management of pain, nausea/vomiting and anxiety in the context of an inpatient pediatric cardiology unit. DESIGN: Telephone interviews were carried out with the parents of pediatric cardiology inpatients. The interviews focused on their and their child's experiences with the PIM service while in the hospital. Interviews were transcribed, and analyzed using qualitative content analysis. RESULTS: Data saturation was reached after nine interviews conducted during the period between June 2015 and January 2016. Parents self-reported that the PIM service was particularly helpful at alleviating symptoms of anxiety in their children. Moreover, because their children were more at ease, parents also felt less anxiety. CONCLUSION: Pediatric integrative medicine as an adjunct to conventional care is seen as beneficial by parents of children admitted to a pediatric cardiology unit.

Efficacy of music on sedation, analgesia and delirium in critically ill patients. A systematic review of randomized controlled trials.

PURPOSE: To systematically synthesize randomized controlled trial data on the efficacy of music to provide sedation and analgesia, and reduce incidence of delirium, in critically ill patients. MATERIAL AND METHODS: Relevant databases (Medline, PubMed, Embase, CINAHL, Cochrane, Alt Healthwatch, LILACS, PsycINFO, CAIRSS, RILM) were searched from inception to April 26, 2018. We also searched the reference lists of included publications and for ongoing trials. The selection of relevant articles was conducted by two researchers at two levels of screening. Data collection followed the recommendations from the Cochrane Systematic Reviews Handbook. We used the Cochrane Collaboration's tool for assessing risk of bias. Quality of the evidence was rated according to GRADE. RESULTS: The review identified six adult studies and no neonatal or pediatric studies. A descriptive analysis of study results was performed. Meta-analysis was not feasible due to heterogeneity. One study reported a reduction in sedation requirements with the use of music while the other five did not find any significant differences across groups. CONCLUSIONS: This systematic review revealed limited evidence to support or refute the use of music to reduce sedation/analgesia requirements, or to reduce delirium in critically ill adults, and no evidence in pediatric and neonatal critically ill patients.

Observational Study of Pediatric Inpatient Pain, Nausea/Vomiting and Anxiety.

Background: The prevalence and severity of pain, nausea/vomiting, and anxiety (PNVA) among hospitalized children is not well established. We describe the prevalence and severity of PNVA among hospitalized patients from oncology, general pediatrics, and cardiology services in a tertiary care center. Methods: Patients were recruited on admission and enrolled if their caregiver consented, spoke English, and were anticipated to stay 2-30 days. Symptoms were measured weekdays using age-validated tools. PNVA symptoms were described and compared. Results: We enrolled 496 (49.4%) patients of 1005 admitted. Patients were predominantly Caucasian (57.9%) on their first admission (53.6%). The average (SD) age was 8.6 years (5.9) in oncology, 4.2 (5.3) in general pediatrics and 2.6 (4.0) in cardiology. 325 (65.6%) patients reported anxiety, 275 (55.4%) reported nausea and 256 (52.0%) reported pain. Mean (SD) severity out of 10 was 3.7 (2.5) for anxiety, 3.2 (2.1) for nausea and 3.0 (1.5) for pain. Prevalence of PNVA was no different between clinical programs, but pain (p = 0.008) and nausea (p = 0.006) severity were. PNVA symptom co-occurrence was positively correlated (p < 0.001). Conclusions: Anxiety was the most common and severe symptom for hospitalized children. Patients in oncology demonstrated the least severe pain and nausea with no difference in anxiety between services.

Surveys of parents and clinicians concerning the minimally important difference of probiotic therapy for prevention of paediatric antibiotic-associated diarrhoea.

OBJECTIVES: To establish the minimally important difference (MID) that would prompt parents and clinicians to use probiotics for prevention of paediatric antibiotic-associated diarrhoea (AAD) and to obtain parent and clinician opinion about the most important outcomes in clinical trials of AAD. METHODS: In this survey, parents of children presenting to the emergency department of a Canadian tertiary care children's hospital and paediatricians working in that hospital were approached. A range of potential MIDs were presented and participants selected one that they would require to use probiotics for AAD prevention. In addition, participants were asked to rate a list of outcomes they would consider to be important in clinical trials of AAD. RESULTS: In total, 127 parents and 45 paediatricians participated. About 51% (64/125) of parents and 51% (21/41) of clinicians responding to the MID question reported they would use probiotics if it reduced the risk of AAD by 39% (ie, reduce the risk of AAD from 19% to 12%). The most important outcomes to parents, in descending order, were need for hospitalisation, prevention of dehydration, disruption of normal daily activities, diarrhoea duration and physician revisit. Paediatricians considered need for hospitalisation along with physician revisit as the most important outcomes. They rated prevention of dehydration, diarrhoea duration and stool frequency as important outcomes as well. CONCLUSION: There is good agreement between parents and clinicians regarding how effective probiotics would need to be in preventing AAD in order to warrant use. This information, along with outcomes perceived to be most important, will help in the design of future clinical trials.

Relaxation training for management of paediatric headache: A rapid review.

The objective of this review was to assess the evidence on relaxation training for management of paediatric headaches. Our methodology was a rapid review of English-language peer reviewed published literature focused on studies evaluating relaxation training as a primary or adjunct management option for headache in a paediatric population (0 to 18 years of age). Seven studies involving 571 children were included in the review. The quality of evidence was very low using GRADE criteria. Headache frequency, duration, and intensity were the primary outcomes in the included studies. Results for the effects of relaxation training for paediatric headache are inconsistent. Four of the seven studies reported decreased headache frequency, two of the five studies reported decreased headache duration, and two of the six studies reported decreased headache intensity following relaxation training. No adverse events were reported. The current state of the evidence for relaxation training for management of paediatric headache is both inconsistent and of very low quality. High-quality research evaluating the effects of relaxation training for paediatric headaches is required to advance the field.

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.

Prospective cohort study on noise levels in a pediatric cardiac intensive care unit.

PURPOSE: To describe noise levels in a pediatric cardiac intensive care unit, and to determine the relationship between sound levels and patient sedation requirements. MATERIALS AND METHODS: Prospective observational study at a pediatric cardiac intensive care unit (PCICU). Sound levels were measured continuously in slow A weighted decibels dB(A) with a sound level meter SoundEarPro® during a 4-week period. Sedation requirement was assessed using the number of intermittent (PRNs) doses given per hour. Analysis was conducted with autoregressive moving average models and the Granger test for causality. RESULTS: 39 children were included in the study. The average (SD) sound level in the open area was 59.4 (2.5) dB(A) with a statistically significant but clinically unimportant difference between day/night hours (60.1 vs. 58.6; p-value < 0.001). There was no significant difference between sound levels in the open area/single room (59.4 vs. 60.8, p-value = 0.108). Peak noise levels were > 90 dB. There was a significant association between average (p-value = 0.030) and peak sound levels (p-value = 0.006), and number of sedation PRNs. CONCLUSION: Sound levels were above the recommended values with no differences between day/night or open area/single room. High sound levels were significantly associated with sedation requirements.

Comparative effectiveness of pediatric integrative medicine as an adjunct to usual care for pediatric inpatients of a North American tertiary care centre: A study protocol for a pragmatic cluster controlled trial.

BACKGROUND: Some pediatric tertiary care centres in North America supplement conventional care with complementary therapies, together known as pediatric integrative medicine (PIM). Evidence to support the safety and efficacy of PIM is emerging, but the cost-effectiveness of an inpatient PIM service has yet to be assessed. METHODS/DESIGN: This study is a pragmatic cluster controlled clinical trial. Usual care will be compared to usual care augmented with PIM in three pediatric divisions; oncology, general medicine, and cardiology at one large urban tertiary care Canadian Children's Hospital. The primary outcome of the feasibility study is enrolment; the primary outcome of the main study is cost-effectiveness. Other secondary outcomes include the prevalence and severity of key symptoms (i.e. pain, nausea/vomiting and anxiety), efficacy of PIM interventions, patient safety, and parent satisfaction. DISCUSSION: This trial will be the first to evaluate the comparative effectiveness, both clinical and cost, of a PIM inpatient service. The evidence from this study will be useful to families, clinicians and decision makers, and will describe the clinical and economic value of PIM services for pediatric patients admitted to hospital.

Corrigendum to "Comparative effectiveness of pediatric integrative medicine as an adjunct to usual care for pediatric inpatients of a North American tertiary care centre: A study protocol for a pragmatic cluster controlled trial" [Contemp. Clin. Trials Commun. (2017) 12-18].

[This corrects the article DOI: 10.1016/j.conctc.2016.11.002.].