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Music Therapy During Botulinum Injections

NCT00178217 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-12-23

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

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.

Sponsors & Collaborators

  • Joan And Harold Feinbloom Supporting Foundation

    collaborator OTHER

  • University of Rochester

    lead OTHER

Principal Investigators

  • Olle Jane Z Sahler, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2014-12-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178217 on ClinicalTrials.gov