Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111861
Recruitment Status : Suspended (COVID-19 - unable to bring patients for intervention due to C-19 restrictions at present)
First Posted : October 1, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Royal Cornwall Hospitals Trust

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: Singing Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : August 18, 2021
Estimated Study Completion Date : August 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intevention
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
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




Primary Outcome Measures :
  1. Completion rate [ Time Frame: One year ]
    Measure of attendance at sessions

  2. Consent rate [ Time Frame: One year ]
    Measure of those offered the programme who consent to take part


Secondary Outcome Measures :
  1. Self reported self efficacy [ Time Frame: One year ]
    Pain Self-efficacy questionnaire

  2. Self reported ability to self-manage pain [ Time Frame: One year ]
    Patient Activation Measure questionnaire

  3. Increased mindfulness Increased mindfulness Increased mindfulness [ Time Frame: One year ]
    Frieburg Mindfulness questionnaire

  4. Self reported well-being [ Time Frame: One year ]
    Edinburgh Warwick Well-being questionnaire

  5. Self reported anxiety depression [ Time Frame: One year ]
    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.

  6. 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).



Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111861


Locations
Layout table for location information
United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3HD
Sponsors and Collaborators
Royal Cornwall Hospitals Trust
Layout table for additonal information
Responsible Party: Royal Cornwall Hospitals Trust
ClinicalTrials.gov Identifier: NCT04111861    
Other Study ID Numbers: 2019 RCHT 61
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations