NCT01456884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

September 29, 2011

Last Update Submit

September 6, 2017

Conditions

Neurological Impairment

Keywords

Music therapyInfantsChildrenAdolescentspediatricpalliative careneurological impairmentmetabolic conditionpain management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Physiological measures

    Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week

Study Arms (2)

Live - Vibroacoustic

EXPERIMENTAL

Treatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two.

Behavioral: Live guitar and vocal music therapyBehavioral: Vibroacoustic Music Therapy

Vibroacoustic - Live

EXPERIMENTAL

Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two.

Behavioral: Live guitar and vocal music therapyBehavioral: Vibroacoustic Music Therapy

Interventions

Live guitar and vocal music therapyBEHAVIORAL

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

Live - VibroacousticVibroacoustic - Live
Vibroacoustic Music TherapyBEHAVIORAL

30 minutes using vibroacoustic mat.

Also known as: Somatron
Live - VibroacousticVibroacoustic - Live

Eligibility Criteria

Age12 Months - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canuck Place Children's Hospice

Vancouver, British Columbia, V6J 2T2, Canada

Location

MeSH Terms

Conditions

Neurologic ManifestationsAgnosia

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Study Officials

  • Liisa Holsti, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Beth Clark, MM

    Canuck Place Children's Hospice

    STUDY DIRECTOR

  • Harold Siden, MD

    Canuck Place Children's Hospice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 21, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

CA(1)