Back to resultsMusic Therapy for Pain Modification in Pediatric Palliative Care
Primary Purpose
Neurological Impairment
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Live guitar and vocal music therapy
Vibroacoustic Music Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Neurological Impairment focused on measuring Music therapy, Infants, Children, Adolescents, pediatric, palliative care, neurological impairment, metabolic condition, pain management
Eligibility 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.
Sites / Locations
- Canuck Place Children's Hospice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Live - Vibroacoustic
Vibroacoustic - Live
Arm Description
Treatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two.
Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two.
Outcomes
Primary Outcome Measures
Behavioural Pain Scores
Non-communicating children's pain checklist scores.
Secondary Outcome Measures
Physiological measures
Heart rate, oxygen saturation, skin conductance
Full Information
NCT ID
NCT01456884
First Posted
September 29, 2011
Last Updated
September 6, 2017
Sponsor
University of British Columbia
Collaborators
American Music Therapy Association, Canuck Place Children's Hospice, Child and Family Research Institute, BC Women's Hospital and Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT01456884
Brief Title
Music Therapy for Pain Modification in Pediatric Palliative Care
Official Title
Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
American Music Therapy Association, Canuck Place Children's Hospice, Child and Family Research Institute, BC Women's Hospital and Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Impairment
Keywords
Music therapy, Infants, Children, Adolescents, pediatric, palliative care, neurological impairment, metabolic condition, pain management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Live - Vibroacoustic
Arm Type
Experimental
Arm Description
Treatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two.
Arm Title
Vibroacoustic - Live
Arm Type
Experimental
Arm Description
Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two.
Intervention Type
Behavioral
Intervention Name(s)
Live guitar and vocal music therapy
Intervention Description
Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Vibroacoustic Music Therapy
Other Intervention Name(s)
Somatron
Intervention Description
30 minutes using vibroacoustic mat.
Primary Outcome Measure Information:
Title
Behavioural Pain Scores
Description
Non-communicating children's pain checklist scores.
Time Frame
Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Secondary Outcome Measure Information:
Title
Physiological measures
Description
Heart rate, oxygen saturation, skin conductance
Time Frame
Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liisa Holsti, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beth Clark, MM
Organizational Affiliation
Canuck Place Children's Hospice
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Harold Siden, MD
Organizational Affiliation
Canuck Place Children's Hospice
Official's Role
Study Director
Facility Information:
Facility Name
Canuck Place Children's Hospice
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 2T2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Music Therapy for Pain Modification in Pediatric Palliative Care
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