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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111861
• Other study ID #: 2019 RCHT 61
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: August 18, 2022

Study information

• Verified date: October 2021
• Source: Royal Cornwall Hospitals Trust
• Contact: Josephine Erwin
• Phone: 01872 256439
• Email: josephine.erwin[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Singing
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

Locations

Country	Name	City	State
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
Royal Cornwall Hospitals Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Focus Group	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
Primary	Completion rate	Measure of attendance at sessions	One year
Primary	Consent rate	Measure of those offered the programme who consent to take part	One year
Secondary	Self reported self efficacy	Pain Self-efficacy questionnaire	One year
Secondary	Self reported ability to self-manage pain	Patient Activation Measure questionnaire	One year
Secondary	Increased mindfulness Increased mindfulness Increased mindfulness	Frieburg Mindfulness questionnaire	One year
Secondary	Self reported well-being	Edinburgh Warwick Well-being questionnaire	One year
Secondary	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.	One year
Secondary	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).	One year