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

Abstract

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.

Pain Management Strategies for Botulinum Toxin Type A Injections in Children: A Comprehensive National Survey and Procedural Protocol

“…Strategies like positive reinforcement, behavioral modeling, guided imagery or hypnoanalgesia, and muscle relaxation and/or breathing exercises before and after the procedure are appropriate [ 6 ]. Other strategies, such as virtual reality, biofeedback-assisted relaxation training, and the presence of Child Life specialists in the room, have been studied and have shown increasing effectiveness in pain control during procedures [ 18 , 20 , 23 , 29 ].…”

“…However, it was possible to extrapolate data for analysis and comparison among 19 out of the 23 articles obtained (Table 2). Ostojic [18] 2022 RCT The sample sizes were very different among the studies, with variability ranging from n=10 to n=758 and an average sample size of 120 children with a mean age of 8.36 years old (min. 3.79; max.…”

Chronic pain in children and young people with cerebral palsy: a narrative review of challenges, advances, and future directions

“…A systematic review examining the efficacy of interventions in children and adolescents with CP (57 studies) found many studies were low-moderate quality [ 10 ]. There is moderate-high evidence to support intrathecal baclofen therapy for pain secondary to hypertonia in spastic and spastic-dyskinetic CP, non-pharmacological interventions (including distraction and biofeedback) for procedural pain, and pharmacological interventions for postoperative pain [ 10 , 61 ]. Low-quality evidence exists for deep brain stimulation to reduce pain severity, frequency, and analgesia requirement in children with severe dystonic CP [ 62 ].…”

“…Pain during and after procedures is common; however, there is a slow uptake of the application of evidence-based, non-pharmacological management in this setting. Research indicates a role for distraction, imagery, and preparation/education for children and young people with CP [ 10 , 61 ].…”

Prevention and treatment of pediatric pain and anxiety caused by botulinum neurotoxin A injections: Inadmissible without nitrous oxide analgesia and sedation?

“…Some institutions that have not implemented nitrous gas for all their patients yet have been exploring treatment alternatives and the study by Ostojic et al is timely in exploring whether topical anesthesia plus either distraction or biofeedback‐assisted relaxation training (BART) might be an alternative to nitrous gas 2 . While the authors did not mention the level of overall pain, worst pain, and fear in their cohort of 38 children mostly with cerebral palsy, the data seem to suggest that neither integrative modality was an effective alternative to nitrous gas.…”