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.

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.