- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456884
Music Therapy for Pain Modification in Pediatric Palliative Care
Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6J 2T2
- Canuck Place Children's Hospice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Live guitar and vocal music therapy.
Subject is passive recipient for 30 minutes.
30 minutes using vibroacoustic mat.
Other Names:
|
EXPERIMENTAL: Vibroacoustic - Live
Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two.
|
Live guitar and vocal music therapy.
Subject is passive recipient for 30 minutes.
30 minutes using vibroacoustic mat.
Other Names:
|
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
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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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