Neurological ImpairmentNCT01456884
Music Therapy for Pain Modification in Pediatric Palliative Care
A study testing Live guitar and vocal music therapy and Vibroacoustic Music Therapy in people with Neurological Impairment, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 months to 19 years
- Conditions the study is for
- Neurological Impairment
- What is being tested?
- Live guitar and vocal music therapy and Vibroacoustic Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canuck Place Children's Hospice
Vancouver, British Columbia, V6J 2T2
About this study
Official title: Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions
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.
Read the 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.
- Conditions
- Neurological Impairment
- Being tested
- Live guitar and vocal music therapy, Vibroacoustic Music Therapy
- Keywords
- Music therapy, Infants, Children, Adolescents, pediatric, palliative care, neurological impairment, metabolic condition, pain management
- Medical subject headings
- Neurologic Manifestations, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live guitar and vocal music therapyBehavioural
Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
Vibroacoustic Music TherapyBehavioural
Also called Somatron
30 minutes using vibroacoustic mat.
| Study group | Role | What they receive |
|---|---|---|
| Live - Vibroacoustic | Experimental | Treatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two. Receives: Behavioral: Live guitar and vocal music therapy; Behavioral: Vibroacoustic Music Therapy |
| Vibroacoustic - Live | Experimental | Treatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two. Receives: Behavioral: Live guitar and vocal music therapy; Behavioral: Vibroacoustic Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural Pain Scores
Non-communicating children's pain checklist scores.
Measured: 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
Heart rate, oxygen saturation, skin conductance
Measured: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ImpairmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Music Therapy Association, Canuck Place Children's Hospice, Child and Family Research Institute, BC Women's Hospital and Health Centre
- Responsible party
- Principal investigator, Liisa Holsti, University of British Columbia
- Investigators
- Liisa Holsti, PhD, Principal investigator, University of British ColumbiaBeth Clark, MM, Study director, Canuck Place Children's HospiceHarold Siden, MD, Study director, Canuck Place Children's Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456884
- Sponsor's protocol ID
- H11-02440
- Status last verified
- Sep 2017
- First submitted
- 29 Sep 2011
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as a Pain Modifying Intervention in Children With Life-limiting Neurological Impairments and Metabolic Conditions
- ClinicalTrials.gov ID
- NCT01456884
- Acronym / sponsor ID
- H11-02440
- Conditions
- Neurological Impairment
- Keywords
- Music therapy, Infants, Children, Adolescents, pediatric, palliative care, neurological impairment, metabolic condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- American Music Therapy Association, Canuck Place Children's Hospice, Child and Family Research Institute, BC Women's Hospital and Health Centre
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live - Vibroacoustic | Experimental | Behavioral: Live guitar and vocal music therapy, Behavioral: Vibroacoustic Music TherapyTreatment order A: live guitar and vocal music therapy on day one, vibroacoustic music therapy on day two. |
| Vibroacoustic - Live | Experimental | Behavioral: Live guitar and vocal music therapy, Behavioral: Vibroacoustic Music TherapyTreatment order B: vibroacoustic music therapy live guitar on day one, and vocal music therapy on day two. |
Who may qualify
- Ages
- 12 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live guitar and vocal music therapyLive guitar and vocal music therapy. Subject is passive recipient for 30 minutes. | Behavioural | Live - Vibroacoustic, Vibroacoustic - Live |
| Vibroacoustic Music TherapyAlso: Somatron30 minutes using vibroacoustic mat. | Behavioural | Live - Vibroacoustic, Vibroacoustic - Live |
Primary outcome
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.
1 secondary outcome
Physiological measures
Time frame: Participants will be observed for a total of 3 hours during one hospice admission, an expected average of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liisa Holsti, PhD principal investigator
University of British Columbia
Beth Clark, MM study director
Canuck Place Children's Hospice
Harold Siden, MD study director
Canuck Place Children's Hospice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live guitar and vocal music therapy and Vibroacoustic Music Therapy in people with Neurological Impairment, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.