Clinical trial NCT01456884: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Impairment
Keywords: Music therapy
Infants
Children
Adolescents
pediatric
palliative care
neurological impairment
metabolic condition
pain management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: American Music Therapy Association
name: Canuck Place Children's Hospice
name: Child and Family Research Institute
name: BC Women's Hospital and Health Centre
First posted: 2011-10-21
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Behavioural Pain Scores
timeFrame: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Secondary outcomes:
measure: Physiological measures
timeFrame: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Canuck Place Children's Hospice
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Liisa Holsti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canuck Place Children's Hospice
name: Beth Clark, MM
role: STUDY_DIRECTOR
affiliation: Canuck Place Children's Hospice
name: Harold Siden, MD
role: STUDY_DIRECTOR
References: