Biofeedback assisted relaxation training and distraction therapy for pain in children undergoing botulinum neurotoxin A injections: A crossover randomized controlled trial.

AIM: To compare biofeedback assisted relaxation training (BART) with distraction therapy for pain during botulinum neurotoxin A (BoNT-A) treatment. METHOD: This was a crossover randomized controlled trial. Eligible participants were 7 years and older with neurological conditions. Participants were randomized to receive BART or distraction during their first BoNT-A treatment, followed by the alternative intervention in their subsequent BoNT-A treatment. BART was delivered via BrightHearts, an interactive heart-rate-responsive application. Outcomes were pain (Faces Pain Scale - Revised), fear (Children's Fear Scale), and anxiety (numerical rating scale, State-Trait Anxiety Inventory). Demographics, paired t-tests, and linear mixed models were used to compare outcomes. RESULTS: Thirty-eight participants (mean [SD] age 13 years 5 months [3 years 4 months], 20 males, 34 with cerebral palsy) completed both interventions. There were non-significant differences in overall pain (mean difference - 0.05, 95% confidence interval [CI] -0.91 to 0.80, p = 0.902) and worst pain (mean difference 0.37, 95% CI -0.39 to 1.13, p = 0.334) when using BART and distraction therapy. There were non-significant differences in fear and anxiety between interventions. Younger age, heightened pre-procedural state anxiety, and Gross Motor Function Classification System levels III and IV were associated with poorer outcomes (p < 0.05). Participants who received BART before distraction therapy reported lower pain and anxiety scores during both BoNT-A treatments (p < 0.05). INTERPRETATION: Children reported similar pain when using BART and distraction therapy. Those who used BART before distraction therapy reported lower pain and anxiety during both treatments. WHAT THIS PAPER ADDS: Children reported similar pain (overall; worst) when using biofeedback assisted relaxation training (BART) and distraction therapy. Children who used BART before distraction therapy reported lower pain and anxiety over both botulinum neurotoxin A treatments. Younger age, pre-procedural state anxiety, and Gross Motor Function Classification System levels III and IV predicted a worse pain experience. Distraction therapy and BART were acceptable non-pharmacological interventions for procedural pain management.

Lived experiences of pain in children and young people with cerebral palsy.

AIM: To explore the lived experiences of pain in children and young people with cerebral palsy (CP). METHOD: Participants were recruited from the Sydney Children's Hospitals Network and the New South Wales/Australian Capital Territory CP Registers. Inclusion criteria were as follows: CP; aged 9 to 17 years; current/past experience of pain; fluent in English; no greater than mild intellectual disability. Purposive sampling ensured representation across age, motor subtypes, and Gross Motor Function Classification System (GMFCS) levels. Semi-structured face-to-face interviews were conducted. Data were analysed following an interpretative phenomenological approach. RESULTS: Ten participants (three male) were included (mean age 14y 5mo, SD 2y), GMFCS levels I (n=4), II (n=3), III (n=2), and IV (n=1). Analysis led to three superordinate themes: (1) Everybody's experience of pain is different; (2) When the pain is winning; (3) 'I know how to deal with it'. Pain contributors and locations varied between children. Pain intruded on school, physical activity, and psychosocial functioning. Children described personalized strategies used to deal with pain. INTERPRETATION: In this study, children self-reported highly individualized pain experiences which interfered with their daily life and psychosocial well-being. There is a need for improvement in pain assessment and a personalized approach to pain management.

Management of pain in children and adolescents with cerebral palsy: a systematic review.

AIM: To determine the efficacy of interventions for the management of pain in children and adolescents with cerebral palsy (CP). METHOD: Electronic databases were searched from the earliest date possible to April 2018 using a mixture of subject headings and free text. Inclusion criteria comprised of studies with (1) diagnosis of CP, (2) under the age of 18 years, (3) intervention for the management of pain, (4) outcome measure of pain, and (5) studies published in English-language peer-reviewed journals. RESULTS: Fifty-seven studies met the eligibility criteria. Pain related to (n=number of studies): hypertonia (n=17), spastic hip disease (n=13), procedures for the management of CP (n=7), postoperative (n=18), and other (n=2). Most of the studies were of level III to level V evidence. INTERPRETATION: There is level II evidence to support intrathecal baclofen therapy for pain secondary to hypertonia in spastic and spastic-dyskinetic CP, and non-pharmacological interventions for procedural pain and pharmacological interventions for postoperative pain. Most studies were restricted by retrospective design and limited use of validated outcome measures. Future research is needed to explore multidisciplinary interventions for chronic pain and pain secondary to dystonia. Clinicians and researchers would benefit from a standardized approach to pain assessment. WHAT THIS PAPER ADDS: The strongest evidence exists for pharmacological treatments for postoperative pain in children and adolescents with cerebral palsy (CP). There is moderate evidence for the efficacy of intrathecal baclofen for pain related to hypertonia in predominately spastic CP. There is a lack of standardization in the assessment of pain. There is limited evidence for multimodal and non-pharmacological strategies in paediatric CP.

The Feasibility of Using the BrightHearts Biofeedback-Assisted Relaxation Application for the Management of Pediatric Procedural Pain: A Pilot Study.

OBJECTIVE: The objective of this pilot study was to assess the acceptability and feasibility of using BrightHearts, a biofeedback-assisted relaxation application (app), in children undergoing painful procedures. METHODS: Thirty children 7 to 18 years of age undergoing a medical procedure (peripheral blood collection, botulinum toxin injection, or intravenous cannula insertion) participated. Participants used BrightHearts, a heart rate-controlled biofeedback-assisted relaxation training app delivered via an iPad with heart rate measured through a pulse oximeter worn on the ear or thumb. Feasibility was assessed through observations and patient, parent/carer, and healthcare professional feedback. Patient, parent/carer, and healthcare professional satisfaction with BrightHearts was rated using investigator-developed surveys. RESULTS: Eighty-three percent of child participants reported that they found BrightHearts helpful during the procedure and that they would use BrightHearts again. All parents and 96% of healthcare professionals indicated they would use BrightHearts again. Sixty-four percent of healthcare providers perceived that BrightHearts assisted with the ease of performing the procedure. Qualitative analyses found 2 themes: (1) BrightHearts calms through providing distraction and biofeedback and (2) the impact of BrightHearts on the procedure. CONCLUSIONS: This pilot study demonstrates the feasibility of using biofeedback-assisted relaxation delivered via the BrightHearts app in children undergoing peripheral blood collection and cannulation. Future studies are required to evaluate BrightHearts' efficacy in reducing pain and anxiety during painful procedures and distinguish the effects of a biofeedback-mediated app from distraction.

Developing BrightHearts: A Pediatric Biofeedback-Mediated Relaxation App to Manage Procedural Pain and Anxiety.

OBJECTIVE: The objective of this study was to develop a child-friendly biofeedback-mediated relaxation device called BrightHearts. METHODS: Qualitative data were collected at a tertiary pediatric hospital to inform an iterative design process. Clinicians participated in expert group interviews to identify practical considerations that would facilitate the use of BrightHearts during procedures and provide feedback on prototype designs. Children 7 to 18 years of age participated in interactive exhibitions of the prototypes and were interviewed about their experiences using BrightHearts. RESULTS: Twenty-four clinicians participated in 6 group interviews. Thirty-nine children participated in interactive exhibitions, and 21 were interviewed. Clinicians placed high value on the following factors in the management of procedural pain: providing children with an element of control, the use of relaxation techniques, and the use of portable electronic devices such as iPads. They highlighted the need for BrightHearts to be cost effective, portable, and capable of engaging children's interest. They confirmed the utility of developing a biofeedback-assisted relaxation device for children. Based on the factors identified by clinicians, BrightHearts was developed as an iPad application (app) paired with a wireless heart rate monitor. The BrightHearts heart rate biofeedback app displays digital geometric artwork that responds to changes in heart rate. Children 7 to 17 years of age understood the concept of biofeedback and operated the app by slowing their heart rates. CONCLUSION: The BrightHearts app can be used to teach children biofeedback-assisted relaxation. Ongoing studies are evaluating its efficacy for the management of procedural pain in children.

Impact of children's influenza-like illnesses on parental quality of life: a qualitative study.

AIMS: Influenza and influenza-like illness (ILI) in otherwise healthy children has considerable impact on their parents. This study explored the impact of children's ILI on parental quality of life (QoL). METHODS: We conducted qualitative in-depth interviews with parents of children aged 6 months-3 years with severe ILI. Children from childcare centres in Sydney, Australia were followed through the 2010 influenza season. Questions covered child's symptoms, parents' experiences including medical care visits, impact on the family's daily routine, and emotional, physical and social well-being. Interviews were analysed using a modified grounded theory approach. RESULTS: We conducted 21 interviews with 23 parents. Five main themes emerged: 'sudden changes in daily life', 'emotional impact', 'social isolation and relationship changes', 'importance of family and friend support' and 'interaction with the medical system'. Perceived practical and emotional support from family and/or friends and consultations with the doctor appeared to moderate the impact. CONCLUSIONS: Severe ILI in children has a considerable impact on their parents' QoL, through disruptions of normal life routine, social isolation and stress in coping with the sick child. These impacts should be considered when introducing flexible workplace policies designed to minimise the impact on parental QoL. Prevention strategies such as vaccinating children against influenza may help alleviate this impact at a population level.

Condition-specific quality of life questionnaires for caregivers of children with pediatric conditions: a systematic review.

PURPOSE: Childhood illness or disability can affect the quality of life (QoL) of the child's primary caregiver. Our aim was to identify, describe the content and systematically review the psychometric properties of condition-specific QoL questionnaires for caregivers of children. METHODS: Medline, PsycInfo, Embase, CINAHL, and the Cochrane library databases were searched from 1 January 1990 to 30 June 2011. Articles related to the development and measurement of caregiver QoL were screened to identify condition-specific questionnaires. The characteristics of the questionnaires were extracted, and their psychometric properties were evaluated using the consensus-based standards for the selection of health measurement instruments checklist with 4-point scale. RESULTS: We identified 25 condition-specific caregiver QoL questionnaires covering 16 conditions. Conditions included atopic dermatitis, asthma, diabetes, oro-facial disorders, and two acute illnesses. Questionnaires were developed predominantly in high-income countries. Questionnaires had the highest quality rating for content validity, followed by hypothesis testing. Methodological quality was satisfactory for criterion validity; fair in reliability and responsiveness; and poor in internal consistency and structural validity. CONCLUSIONS: The increasing number of questionnaires developed over time shows improved recognition of the importance of caregiver QoL. There is a paucity of QoL questionnaires for caregivers of otherwise healthy children suffering from physical injuries and acute conditions associated with significant caregiver burden. Cultural validation of existing and new questionnaires in lower-income countries is necessary. Data collected by condition-specific questionnaires can assist clinicians and health economists in estimating caregiver burden and the types of healthcare services caregivers require and may be useful for healthcare administrators to evaluate interventions.

Adverse events and health status following botulinum toxin type A injections in children with cerebral palsy.

AIM: The aim of this study was to assess changes in health status before and after, as well as adverse events after, botulinum toxin type A (BoNT-A) injections in children with cerebral palsy (CP). METHOD: A total of 334 children (190 male; 144 female) aged 1y 6mo to 19y 4mo (mean 9y 2mo, SD 4y) with CP who were undergoing BoNT-A injections (596 injection courses in total) were clinically audited over a 16-month period. Of the 334 children, 62 were classified at Gross Motor Function Classification System (GMFCS) level I, 52 of whom had unilateral CP and 10 of whom had bilateral CP. Eighty-six children were classified at GMFCS level II, 39 of whom had unilateral CP and 47 of whom had bilateral CP. Forty-four children were classified at GMFCS level III, two of whom had unilateral CP and 42 of whom had bilateral CP. Sixty-six of the 334 children were classified at GMFCS level IV and 76 as level V. All the children classified as level IV or V had bilateral involvement. The health status of the children in the month before and a prospective audit of health status and adverse events in the month after BoNT-A injections were examined in order to assess the effects of the toxin. RESULTS: The data gathered for the month before administration of BoNT-A indicated that children with CP had significant background morbidities. After injection of BoNT-A, adverse events occurred in 23.2% of children. All adverse events were temporary and there were no deaths. INTERPRETATION: The results of this audit indicate that there is insufficient evidence to warrant restriction of the administration of BoNT-A in children with CP at any GMFCS level in our service.

Assessing quality of life in paediatric clinical practice.

The rising prevalence of children with chronic conditions has made quality of life an increasingly important outcome measure in paediatric practice. The discrepancy between doctors' and patients' perceptions of quality of life makes formal assessment necessary. In this paper we use a case scenario to answer commonly asked questions. What is quality of life and who can assess it? Why assess quality of life in the clinical setting? Is it feasible to measure in routine clinical practice? How is quality of life formally assessed? We provide a basic outline of the language and methods of quality of life assessment and use the case scenario to discuss the process of choosing an appropriate instrument. We conclude that quality of life assessment in clinical practice is feasible and provides benefits for both patients and doctors. The benefits include better informed doctors, improved patient doctor communication and a means to effectively monitor quality of life as a treatment outcome.