Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Duration of recruitment
研究概览
简要总结
Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on women's lives and the (National Health Service) NHS.
CPP may be related to internal organs, the nervous system or psychological factors and is often difficult to treat. Surgery and drugs have risks and side effects, are expensive and do not help all patients.
Psychological treatments have potential to improve CPP but are not consistently available. Mindfulness meditation teaches people to accept their sensations and emotions in the present moment. This can help to accept pain better, which enables patients to focus on daily activities and improve their quality of life. It has been shown to help in headache, back pain and depression. Usually mindfulness meditation is taught by attending courses for 8 weeks.
The investigators want to find out in a full-scale trial if mindfulness meditation, taught by using a smartphone app, can help CPP patients.
In preparation for this full-scale study the investigators will conduct the MEMPHIS study to answer the following questions:
- How many patients are willing to participate?
- How often they use the app?
- Reasons for not wanting to participate/not using the app -
- Which health questionnaires are the most useful ones?
- How many patients will be required for the full-scale trial?
Patients will receive the usual treatment and be divided into three groups
- using a 60-day mindfulness meditation app,
-- using comparison app with progressive muscle relaxation but no meditation
- no app
Patients will complete health questionnaires, may be asked to comment in a focus group and record pain, medication changes, surgery and emergency medical visits
详细描述
CPP affects up to 24% women worldwide accounts for 20% of UK gynaecological clinic referrals and has a considerable impact on patients' quality of life and their income. CPP costs the NHS € 3.3bn per year. Despite costly interventions CPP is often resistant to surgical and medical treatment. Multifactorial psychological and somatic causes require a multidimensional approach. Psychological and somatic causes require a multidimensional approach, which is not routinely offered in gynaecology clinics.
Randomized Control Trial (RCT-) evidence suggests that primary inclusion of psychological interventions may be superior to primary surgery. Although psychological treatment is provided across the NHS, mostly in the context of primary care Improving Access to Psychological
Therapies there are problems with capacity, waiting times and overall number of patients being able to access services. Alternatively, patient self-management (PSM) is now recognised as a tool empowering patients to cope better with their condition.
Mindfulness meditation is a potentially valuable PSM tool in CPP.
The investigators conducted a systematic search of literature (07/2013, updated 12/2013) and found no RCTs on mindfulness meditation in CPP. However, two small pilot trials, one in CPP and one in endometriosis patients with promising results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of organic and non-organic chronic pelvic pain (CPP) for six months or more
- •Age ≥ 18 years
- •Be capable of understanding the information provided, with use of an interpreter if required and being able to understand simple English as is used in the app
排除标准
- •Absence of diagnosis of organic and non-organic chronic pelvic pain (CPP)
- •Diagnosis of organic and non-organic chronic pelvic pain (CPP) lasting for less than 3 months
- •Age < 18 years
- •No access to a Personal computer or smart phone
- •Unable to speak / understand English
- •Current users of the app content available to the public
研究组 & 干预措施
Mindfulness: Group A
Using a 60-day mindfulness instruction meditation app: 60 days of 10 and 20 minute long app modules with a spoken guide to mindfulness meditation, to be used once a day, including modules on the basics of mindfulness and a module targeted to pain, which can re-revisited until the end of the study
干预措施: Mindfulness meditation (Behavioral)
Relaxation: Group B
Using comparison relaxation app with a series of non-meditative progressive muscle relaxation instructions: 60 days of 10 and 20 minute long app modules to be used once per day with spoken words and relaxing sounds, which can re-revisited until the end of the study
干预措施: Relaxation app (Behavioral)
Treatment as usual: Group C
No app: treatment as usual (watch and wait, medication and/or surgery) to investigate if any app intervention makes a difference to wellbeing and to ascertain dropout rates for the full-scale trial in patients who perceive that they are getting no intervention.
结局指标
主要结局
Duration of recruitment
时间窗: 6 months
Length of time it will take to recruit 90 participant from the time recruitment starts
Patient adherence to app use
时间窗: first 8 weeks post-randomisation
次要结局
- Pain acceptance score (as measured Chronic Pain Acceptance Questionnaire (CPAQ-8)(at 60 days, 3 months, and 6 months post-randomisation)
- Quality of life score-Physical Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)(at 60 days, 3 months, and 6 months post-randomisation)
- Quality of life score-Social Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)(at 60 days, 3 months, and 6 months post-randomisation)
- Quality of life score-Pain subscale (as measured by the RAND Short form Health Survey (SF-36)(at 60 days, 3 months, and 6 months post-randomisation)
- Quality of life score-General Health subscale (as measured by the RAND Short form Health Survey (SF-36)(at 60 days, 3 months, and 6 months post-randomisation)
- Depression score as measured by the Hospital Anxiety and Depression Scale (HADS)(at 60 days, 3 months, and 6 months post-randomisation)
- Anxiety score (as measured by HADS)(at 60 days, 3 months, and 6 months post-randomisation)
- Mindfulness score as measure by the Cognitive and Mindfulness - Revised (CAMS - R) scale(at 60 days, 3 months, and 6 months post-randomisation)
- Pain related disability score (as measured by the Chronic Pain Grade (CPG) disability subscale(at 60 days, 3 months, and 6 months post-randomisation)
- Self efficacy score (as measured by the Pain Self-Efficacy Questionnaire (PSEQ)(at 60 days, 3 months, and 6 months post-randomisation)
- Sexual Health Outcomes score (as measured by Sexual Health Outcomes in Women Questionnaire (SHOW-Q)(at 60 days, 3 months, and 6 months post-randomisation)
- Subjective outcome score (as measured by Measure Yourself Medical Outcome Profile (MYMOP)(at 60 days, 3 months, and 6 months post-randomisation)