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Music Therapy for Pain Modification in Pediatric Palliative Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456884
First Posted: October 21, 2011
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Music Therapy Association
Canuck Place Children's Hospice
Child and Family Research Institute
BC Women's Hospital and Health Centre
Information provided by (Responsible Party):
Liisa Holsti, University of British Columbia
  Purpose
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.

Condition Intervention
Neurological Impairment Behavioral: Live guitar and vocal music therapy Behavioral: Vibroacoustic Music Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions

Further study details as provided by Liisa Holsti, University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: January 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Somatron

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456884


Locations
Canada, British Columbia
Canuck Place Children's Hospice
Vancouver, British Columbia, Canada, V6J 2T2
Sponsors and Collaborators
University of British Columbia
American Music Therapy Association
Canuck Place Children's Hospice
Child and Family Research Institute
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
  More Information

Responsible Party: Liisa Holsti, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01456884     History of Changes
Other Study ID Numbers: H11-02440
First Submitted: September 29, 2011
First Posted: October 21, 2011
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Liisa Holsti, University of British Columbia:
Music therapy
Infants
Children
Adolescents
pediatric
palliative care
neurological impairment
metabolic condition
pain management

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms