Music Therapy for Pain Modification in Pediatric Palliative Care

This study is ongoing, but not recruiting participants.
Sponsor:
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):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01456884
First received: September 29, 2011
Last updated: February 27, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Heart rate, oxygen saturation, skin conductance


Estimated Enrollment: 25
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   12 Months to 19 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01456884     History of Changes
Other Study ID Numbers: H11-02440
Study First Received: September 29, 2011
Last Updated: February 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2014