NCT00178217

Brief Summary

The primary objectives for this study are:

  1. 1.To demonstrate that music therapy can be an effective means of procedural support for children undergoing botox injections.
  2. 2.To explore patient, parent and healthcare personnel satisfaction with music therapy as procedural support.
  3. 3.To assess the influence of music therapy on physiologic (blood pressure, oxygen saturation, heart rate) and emotional (crying time) responses of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

12.4 years

First QC Date

September 12, 2005

Last Update Submit

December 22, 2015

Conditions

Cerebral Palsy

Keywords

Botulinum ToxinMusic TherapyCerebral PalsyProcedural Support

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • When patients receive music therapy, they will be more likely to undergo Botox injections without the use of sedation.

    By end of study

Study Arms (2)

Music Therapy

EXPERIMENTAL

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

Standard Care Control

NO INTERVENTION

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.

Interventions

Music TherapyBEHAVIORAL

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.

Music Therapy

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related 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.

    RESULT

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Olle Jane Z Sahler, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Psychiatry, Medical Humanities & Oncology

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2002

Primary Completion

December 1, 2014

Study Completion

November 1, 2015

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)