Cerebral Palsy Clinical Trial
Official title:
Music Therapy as Procedural Support During Botulinum Injections for Pediatric Patients
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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