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Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Singing
Sponsored by
Royal Cornwall Hospitals Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Cornwall HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intevention

Arm Description

To see if singing can be used as a detractive method from patients experiencing ongoing pain.

Outcomes

Primary Outcome Measures

Completion rate
Measure of attendance at sessions
Consent rate
Measure of those offered the programme who consent to take part

Secondary Outcome Measures

Self reported self efficacy
Pain Self-efficacy questionnaire
Self reported ability to self-manage pain
Patient Activation Measure questionnaire
Increased mindfulness Increased mindfulness Increased mindfulness
Frieburg Mindfulness questionnaire
Self reported well-being
Edinburgh Warwick Well-being questionnaire
Self reported anxiety depression
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.
Self reported quality of life
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).

Full Information

First Posted
September 10, 2019
Last Updated
November 8, 2021
Sponsor
Royal Cornwall Hospitals Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04111861
Brief Title
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
Official Title
Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
August 18, 2022 (Anticipated)
Study Completion Date
August 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Cornwall Hospitals Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intevention
Arm Type
Experimental
Arm Description
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
Intervention Type
Other
Intervention Name(s)
Singing
Intervention Description
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
Primary Outcome Measure Information:
Title
Completion rate
Description
Measure of attendance at sessions
Time Frame
One year
Title
Consent rate
Description
Measure of those offered the programme who consent to take part
Time Frame
One year
Secondary Outcome Measure Information:
Title
Self reported self efficacy
Description
Pain Self-efficacy questionnaire
Time Frame
One year
Title
Self reported ability to self-manage pain
Description
Patient Activation Measure questionnaire
Time Frame
One year
Title
Increased mindfulness Increased mindfulness Increased mindfulness
Description
Frieburg Mindfulness questionnaire
Time Frame
One year
Title
Self reported well-being
Description
Edinburgh Warwick Well-being questionnaire
Time Frame
One year
Title
Self reported anxiety depression
Description
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.
Time Frame
One year
Title
Self reported quality of life
Description
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).
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Patient Focus Group
Description
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
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josephine Erwin
Phone
01872 256439
Email
josephine.erwin@nhs.net
Facility Information:
Facility Name
Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Erwin

12. IPD Sharing Statement

Learn more about this trial

Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain

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