Music Therapy During Botulinum Injections

Cerebral Palsy Clinical Trial

Official title:

Music Therapy as Procedural Support During Botulinum Injections for Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178217
• Other study ID #: 9507
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: December 22, 2015
• Start date: July 2002
• Est. completion date: November 2015

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Music Therapy
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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Joan And Harold Feinbloom Supporting Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

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

External Links

•   American Music Therapy Association Home Page