Music Therapy for Pain Modification in Pediatric Palliative Care
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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 |
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | April 2013 (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: | 1 Month to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children, ages 0-19, 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| Contact: Gail Andrews, MEd | 604.875.2000 ext 5345 | gandrews@cw.bc.ca |
| Contact: Liisa Holsti, PhD | 604.875.2000 ext 5200 | lholsti@cw.bc.ca |
| Canada, British Columbia | |
| Canuck Place Children's Hospice | Recruiting |
| Vancouver, British Columbia, Canada, V6J 2T2 | |
| Contact: Harold Siden, MD 604.731.4847 hsiden@cw.bc.ca | |
| Contact: Beth Clark, MM 604.731.4847 bclark4@canuckplace.org | |
| Principal Investigator: Harold Siden, MD | |
| Sub-Investigator: Beth Clark, MM | |
| 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: | January 11, 2013 |
| 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 May 22, 2013