Chronic PainNCT04111861
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
A study testing Singing in people with Chronic Pain, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Singing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2020to 18 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Cornwall Hospital
Truro, Cornwall, TR1 3HD
Jo Erwin
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Singing
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intevention | Experimental | To see if singing can be used as a detractive method from patients experiencing ongoing pain. Receives: Other: Singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
Measure of attendance at sessions
Measured: One year
Consent rate
Measure of those offered the programme who consent to take part
Measured: One year
Secondary outcomes (6)
Self reported self efficacy
Pain Self-efficacy questionnaire
Measured: One year
Self reported ability to self-manage pain
Patient Activation Measure questionnaire
Measured: One year
Increased mindfulness Increased mindfulness Increased mindfulness
Frieburg Mindfulness questionnaire
Measured: One year
Self reported well-being
Edinburgh Warwick Well-being questionnaire
Measured: One year
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.
Measured: One year
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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Mar 2020
- Primary completion18 Aug 2022 (estimated)
- Study completion18 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111861
- Sponsor's protocol ID
- 2019 RCHT 61
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT04111861
- Acronym / sponsor ID
- 2019 RCHT 61
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 18 Aug 2022 (estimated)
- Study completion
- 18 Aug 2022 (estimated)
- First posted
- 1 Oct 2019 (actual)
- 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intevention | Experimental | Other: SingingTo see if singing can be used as a detractive method from patients experiencing ongoing pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| SingingTo 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 | Other | Intevention |
Primary outcome
Completion rate
Time frame: One year
Measure of attendance at sessions
Consent rate
Time frame: One year
Measure of those offered the programme who consent to take part
6 secondary outcomes
Self reported self efficacy
Time frame: One year
Self reported ability to self-manage pain
Time frame: One year
Increased mindfulness Increased mindfulness Increased mindfulness
Time frame: One year
Self reported well-being
Time frame: One year
Self reported anxiety depression
Time frame: One year
Self reported quality of life
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing in people with Chronic Pain, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josephine Erwin (01872 256439, josephine.erwin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: One year). The study lists 2 primary outcomes in all. 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 9 Nov 2021.