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Completed

NCT Number: NCT01456884

Music Therapy for Pain Modification in Pediatric Palliative Care

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.

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Key information

Age range

12 month–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canuck Place Children's Hospice

Vancouver, British Columbia, V6J 2T2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live guitar and vocal music therapy

Behavioral

Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.

Vibroacoustic Music Therapy

Behavioral

30 minutes using vibroacoustic mat.

Other names: Somatron

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • American Music Therapy Association
  • BC Women's Hospital and Health Centre
  • Canuck Place Children's Hospice
  • Child and Family Research Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2011
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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