Music Therapy for Pain Modification in Pediatric Palliative Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions

Conditions
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Neurological Impairment

Intervention / Treatment
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* Behavioral: Live guitar and vocal music therapy
* Behavioral: Vibroacoustic Music Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live - Vibroacoustic<br>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<br>* Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.<br>Behavioral: Vibroacoustic Music Therapy<br>* 30 minutes using vibroacoustic mat.<br>* Other names: Somatron;|
| Experimental: Vibroacoustic - Live<br>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<br>* Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.<br>Behavioral: Vibroacoustic Music Therapy<br>* 30 minutes using vibroacoustic mat.<br>* Other names: Somatron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural Pain Scores | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Infants, Music therapy, Adolescents, pediatric, palliative care, neurological impairment, metabolic condition, pain management