Music Therapy for Pain Modification in Pediatric Palliative Care

September 6, 2017 updated by: Liisa Holsti, University of British Columbia

Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions

The purpose of this within-subjects randomized controlled trial is to determine whether two music therapy interventions are efficacious in reducing pain symptoms, in order to improve the quality of care for children in pediatric hospice. The investigators hypothesize that both music therapy interventions, live guitar and vocal intervention and vibroacoustic intervention, will reduce behavioural pain scores and that behavioural pain scores will correlate with physiological outcome measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective pain management in pediatric palliative care is a quality of life issue for patients, families and professionals. Current research supports the use of music therapy to assist with pain management in pediatric medical settings. However, little research has been done to explore the use of music therapy for reducing pain in children with life-limiting neurological impairments or metabolic conditions.

As the first known project to examine the effects of music therapy on pain symptoms with children who have life-limiting neurological impairments or metabolic disorders, this study will expand the evidence-base for practice with this population. It is imperative that an evidence base for music therapy in this area be established, so that the most effective interventions can be provided to these vulnerable children.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J 2T2
        • Canuck Place Children's Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children, ages 1-19, who have been diagnosed with life-limiting neurological impairments and metabolic conditions
  • Cognitive functioning level of one year or less will be enrolled in the study
  • Receiving respite or symptom management care at the time of admission to the Canuck Place Children's Hospice
  • Guardians must be able to provide written consent in English; interpreters will be available if a guardian needs clarification on specific points.

Exclusion Criteria:

  • Children who are actively dying (i.e. admitted for end-of-life care or determined by physicians to require immediate end-of-life care)
  • Any history of adverse responses to live or recorded music or to vibroacoustic stimulation
  • Severe to profound hearing impairment will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Live - Vibroacoustic
Treatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two.
Behavioral: Live guitar and vocal music therapy
Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
Behavioral: Vibroacoustic Music Therapy
30 minutes using vibroacoustic mat.
Other Names:
  • Somatron
EXPERIMENTAL: Vibroacoustic - Live
Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two.
Behavioral: Live guitar and vocal music therapy
Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
Behavioral: Vibroacoustic Music Therapy
30 minutes using vibroacoustic mat.
Other Names:
  • Somatron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural Pain Scores
Time Frame: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Non-communicating children's pain checklist scores.
Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological measures
Time Frame: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Heart rate, oxygen saturation, skin conductance
Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Child and Family Research Institute
American Music Therapy Association
Canuck Place Children's Hospice
BC Women's Hospital and Health Centre

Investigators

  • Principal Investigator: Liisa Holsti, PhD, University of British Columbia
  • Study Director: Beth Clark, MM, Canuck Place Children's Hospice
  • Study Director: Harold Siden, MD, Canuck Place Children's Hospice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (ESTIMATE)

October 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-02440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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