- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111861
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
The aim of the project is to determine the feasibility of delivering a Singing for Chronic Pain (SCP) programme to patients with chronic pain attending a pain clinic.
The investigator will also be looking to provide a preliminary estimate of the benefit of SCP on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Josephine Erwin
- Phone Number: 01872 256439
- Email: josephine.erwin@nhs.net
Study Locations
-
-
Cornwall
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Truro, Cornwall, United Kingdom, TR1 3HD
- Recruiting
- Royal Cornwall Hospital
-
Contact:
- Jo Erwin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.
Exclusion Criteria:
- Having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; Severe hearing impairment; Severe/profound cognitive impairment that may limit active engagement/participation in group sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intevention
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
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To investigate whether singing can help people to manage their chronic pain the applicants, working together with people with chronic pain, have developed a singing intervention, Singing for Chronic Pain (SCP).
The development of the programme has been supported by Snape Moultings, an international centre for the arts which offered the team a residency to develop the programme (https://snapemaltings.co.uk/music/residencies/).
The model takes a holistic approach using voice and singing, movement, sound, mindfulness and breath work to provide opportunities to connect body, voice, breath and mind.
This is important given that people often use body dissociation as a way to cope with physical pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion rate
Time Frame: One year
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Measure of attendance at sessions
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One year
|
Consent rate
Time Frame: One year
|
Measure of those offered the programme who consent to take part
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self reported self efficacy
Time Frame: One year
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Pain Self-efficacy questionnaire
|
One year
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Self reported ability to self-manage pain
Time Frame: One year
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Patient Activation Measure questionnaire
|
One year
|
Increased mindfulness Increased mindfulness Increased mindfulness
Time Frame: One year
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Frieburg Mindfulness questionnaire
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One year
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Self reported well-being
Time Frame: One year
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Edinburgh Warwick Well-being questionnaire
|
One year
|
Self reported anxiety depression
Time Frame: One year
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Hospital Anxiety and Depression questionnaire.The HADS is a fourteen item scale that generates ordinal data.
Seven of the items relate to anxiety and seven relate to depression.
Anxiety scores and depression scores can range for 0 -21 with a higher score being worse.
The separate depression and anxiety scores scores can be combined to give an overall score.
|
One year
|
Self reported quality of life
Time Frame: One year
|
EQ5D Quality of Life Questionnaire The EQ-5D questionnaire has two components: health state description and evaluation.Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).he answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Focus Group
Time Frame: One year
|
At week 10, participants will be invited to take part in a 60 minute focus group led by an experienced researcher.
The focus groups will explore participants' perception of the programme and its outcomes, reasons for noncompliance, instrument appropriateness and suggestions for programme improvement
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 RCHT 61
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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