NCT04111861

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

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 10, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

September 10, 2019

Last Update Submit

November 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Completion rate

    Measure of attendance at sessions

    One year

  • Consent rate

    Measure of those offered the programme who consent to take part

    One year

Secondary Outcomes (6)

  • Self reported self efficacy

    One year

  • Self reported ability to self-manage pain

    One year

  • Increased mindfulness Increased mindfulness Increased mindfulness

    One year

  • Self reported well-being

    One year

  • Self reported anxiety depression

    One year

  • +1 more secondary outcomes

Other Outcomes (1)

  • Patient Focus Group

    One year

Study Arms (1)

Intevention

EXPERIMENTAL

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

Other: Singing

Interventions

SingingOTHER

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

Intevention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3HD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Singing

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

October 1, 2019

Study Start

March 3, 2020

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

November 9, 2021

Record last verified: 2021-10

Locations