Music Therapy for Pain Modification in Pediatric Palliative Care

Neurological Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456884
• Other study ID #: H11-02440
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: September 6, 2017
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurologic Manifestations
• Neurological Impairment

Intervention

Behavioral:
• Live guitar and vocal music therapy
Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
• Vibroacoustic Music Therapy
30 minutes using vibroacoustic mat.

Locations

Country	Name	City	State
Canada	Canuck Place Children's Hospice	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	American Music Therapy Association, BC Women's Hospital and Health Centre, Canuck Place Children's Hospice, Child and Family Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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