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