Cerebral Palsy Clinical Trial
Official title:
Music Therapy as Procedural Support During Botulinum Injections for Pediatric Patients
Verified date | December 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | November 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 17 Years |
Eligibility |
Inclusion Criteria: - Treatment for diplegic or hemiplegic cerebral palsy or muscle spasticity resulting from brain injury, with Botulinum toxin injections. Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Joan And Harold Feinbloom Supporting Foundation |
United States,
Sahler OJZ, Hunter BC, Oliva R, Du C, Hoffman T, Liptak G, Cole,LL. "Music Therapy as Procedural Support During Botulinum Toxin Injections". Pediatric Academic Societies. Pediatr Res 2004; 55:87A, Abstract 492.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Music therapy will be effectively integrated as a means of procedural support for children undergoing botox injections with a success rate of 80% in enrolling, treating and collecting data from study subjects. | End of study | No | |
Primary | Music therapy will increase satisfaction by decreasing the distress related to botox injections for child, parent and medical staff. | From beginning to end of session | No | |
Primary | Subjects receiving music therapy will demonstrate less procedure-related distress as manifested by: Less of an increase in blood pressure and heart rate, less of a decrease in oxygen saturation, and a lower proportion of procedure time spent crying | From beginning to end of session | No | |
Secondary | When patients receive music therapy, they will be more likely to undergo Botox injections without the use of sedation. | By end of study | No |
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