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

2021年11月8日 更新者:Royal Cornwall Hospitals Trust

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (预期的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Cornwall
      • Truro、Cornwall、英国、TR1 3HD
        • 招聘中
        • Royal Cornwall Hospital
        • 接触:
          • Jo Erwin

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intevention
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Completion rate
大体时间:One year
Measure of attendance at sessions
One year
Consent rate
大体时间:One year
Measure of those offered the programme who consent to take part
One year

次要结果测量

结果测量
措施说明
大体时间
Self reported self efficacy
大体时间:One year
Pain Self-efficacy questionnaire
One year
Self reported ability to self-manage pain
大体时间:One year
Patient Activation Measure questionnaire
One year
Increased mindfulness Increased mindfulness Increased mindfulness
大体时间:One year
Frieburg Mindfulness questionnaire
One year
Self reported well-being
大体时间:One year
Edinburgh Warwick Well-being questionnaire
One year
Self reported anxiety depression
大体时间: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.
One year
Self reported quality of life
大体时间: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).

One year

其他结果措施

结果测量
措施说明
大体时间
Patient Focus Group
大体时间: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
One year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月3日

初级完成 (预期的)

2022年8月18日

研究完成 (预期的)

2022年8月18日

研究注册日期

首次提交

2019年9月10日

首先提交符合 QC 标准的

2019年9月30日

首次发布 (实际的)

2019年10月1日

研究记录更新

最后更新发布 (实际的)

2021年11月9日

上次提交的符合 QC 标准的更新

2021年11月8日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2019 RCHT 61

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研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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