Music Therapy During Botulinum Injections
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives for this study are:

        1. To demonstrate that music therapy can be an effective means of procedural support for
           children undergoing botox injections.

        2. To explore patient, parent and healthcare personnel satisfaction with music therapy as
           procedural support.

        3. To assess the influence of music therapy on physiologic (blood pressure, oxygen
           saturation, heart rate) and emotional (crying time) responses of patients.
    

Detailed description: 
      Many children with spastic Cerebral Palsy and other types of muscle dystonia are injected
      with Botulinum toxin A (Botox) to reduce pathological reflexes and improve muscle function.
      Such treatment requires injections to each affected muscle group, which can be both painful
      and distressing. Music therapy has been shown to reduce pain and decrease stress and anxiety
      for pediatric patients undergoing other types of medical procedures.

      The goal of this study is to determine whether music therapy can be effectively integrated as
      a means of procedural support during Botox injections. This study investigates the efficacy
      of music therapy in reducing manifestations of pain during Botox injections. Secondary
      benefits may include increased satisfaction among medical personnel and parents.

      Patients between the ages of 2-17 being treated with Botox were eligible for enrollment.
      Prior to the start of this study, patients had the option of receiving music therapy support
      during their Botox injections; these subjects continued to receive music therapy upon
      enrolling in the study. Subjects who had not previously received music therapy were
      videotaped for two Botox sessions before having a music therapy intervention. The percentage
      of crying time during the procedure was calculated from videotapes taken during the sessions.
      Surveys were given to parent/guardians and the healthcare provider performing the procedure
      to provide feedback on the effectiveness of the music intervention for the child and
      themselves.

      Comparing average crying times for 44 children's first study visit with or without music
      therapy shows that children who receive music therapy cry less than children who do not,
      although the difference is not statistically significant. Both parent and healthcare provider
      surveys indicate a high level of satisfaction with the music therapy intervention.

      The current data indicate that music therapy may be a highly effective means of procedural
      support, but strong conclusions cannot be drawn without more data.
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): The music therapy intervention will consist of approximately 30 minutes of active music making and/or improvisation. The session will begin at least 15 minutes prior to receiving the Botox injections, followed by the necessary time of the procedure and 10 minutes following. During this time the patient will be encouraged to actively engage in a musical activity of his/her choice. After the last injection has been administered, the monitoring and music therapy will continue for up to 10 minutes, and focus on soothing and relaxation rather than on distraction.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Botulinum Toxin; Music Therapy; Cerebral Palsy; Procedural Support