- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04111861
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Josephine Erwin
- 전화번호: 01872 256439
- 이메일: josephine.erwin@nhs.net
연구 장소
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Cornwall
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Truro, Cornwall, 영국, TR1 3HD
- 모병
- Royal Cornwall Hospital
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연락하다:
- Jo Erwin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intevention
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Completion rate
기간: One year
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Measure of attendance at sessions
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One year
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Consent rate
기간: One year
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Measure of those offered the programme who consent to take part
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One year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Self reported self efficacy
기간: One year
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Pain Self-efficacy questionnaire
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One year
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Self reported ability to self-manage pain
기간: One year
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Patient Activation Measure questionnaire
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One year
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Increased mindfulness Increased mindfulness Increased mindfulness
기간: One year
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Frieburg Mindfulness questionnaire
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One year
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Self reported well-being
기간: One year
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Edinburgh Warwick Well-being questionnaire
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One year
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Self reported anxiety depression
기간: One year
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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.
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One year
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Self reported quality of life
기간: One year
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient Focus Group
기간: One year
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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
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One year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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