Music Therapy During Botulinum Injections

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Joan And Harold Feinbloom Supporting Foundation
Information provided by (Responsible Party):
OJ Sahler, University of Rochester
ClinicalTrials.gov Identifier:
NCT00178217
First received: September 12, 2005
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Cerebral Palsy
Behavioral: Music Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Music Therapy as Procedural Support During Botulinum Injections for Pediatric Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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. [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Music therapy will increase satisfaction by decreasing the distress related to botox injections for child, parent and medical staff. [ Time Frame: From beginning to end of session ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: From beginning to end of session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • When patients receive music therapy, they will be more likely to undergo Botox injections without the use of sedation. [ Time Frame: By end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2002
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
No Intervention: Standard Care Control
Subjects will receive standard care at control condition sessions, which includes the use of television, books, CD's, a child life specialist (when available) or other activities to help cope with the procedure.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment for diplegic or hemiplegic cerebral palsy or muscle spasticity resulting from brain injury, with Botulinum toxin injections.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178217

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Joan And Harold Feinbloom Supporting Foundation
Investigators
Principal Investigator: Olle Jane Z Sahler, MD University of Rochester
  More Information

Additional Information:
Publications:
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.

Responsible Party: OJ Sahler, Professor of Pediatrics, Psychiatry, Medical Humanities & Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT00178217     History of Changes
Other Study ID Numbers: 9507
Study First Received: September 12, 2005
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Botulinum Toxin
Music Therapy
Cerebral Palsy
Procedural Support

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014