Mindfulness Meditation for Chronic Pelvic Pain Management (MEMPHIS)
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|ClinicalTrials.gov Identifier: NCT02721108|
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : September 20, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pelvic Pain||Behavioral: Mindfulness meditation Behavioral: Relaxation app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: 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
Behavioral: Mindfulness meditation
The meditation content is a structured and progressive course, layering in new techniques and concepts over successive sessions. The course was created and narrated by a former monk - Andy Puddicombe - drawing on a secularised version of the techniques he was taught over 10 years' experience in monasteries around the world. The first 30 days cover basic techniques, assuming no previous experience of meditation. The second 30 days focus specifically on the use of these techniques with respect to pain. The duration of individual sessions builds over time. Days 1-10 are 10 minutes in duration, days 11-20 are 15 minutes in duration, and days 21-60 are 20 minutes in duration.
Active Comparator: 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
Behavioral: Relaxation app
The Active Control group will use the same app, but the app will be configured so that they will hear a series of non-meditative progressive muscle relaxation instructions, also narrated by Andy Puddicombe. These sessions will be identical every day, except that their duration will increase to mirror the increasing duration of the meditation content being listened to by the Intervention group.
No Intervention: 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.
- Duration of recruitment [ Time Frame: 6 months ]Length of time it will take to recruit 90 participant from the time recruitment starts
- Patient adherence to app use [ Time Frame: first 8 weeks post-randomisation ]
- Quality of life score-Physical Functioning subscale (as measured by the RAND Short form Health Survey (SF-36) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Depression score as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Anxiety score (as measured by HADS) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Mindfulness score as measure by the Cognitive and Mindfulness - Revised (CAMS - R) scale [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Pain related disability score (as measured by the Chronic Pain Grade (CPG) disability subscale [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Self efficacy score (as measured by the Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Pain acceptance score (as measured Chronic Pain Acceptance Questionnaire (CPAQ-8) [ Time Frame: 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) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
- Subjective outcome score (as measured by Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: at 60 days, 3 months, and 6 months post-randomisation ]
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): NCT02721108
|Barts Health NHS Trust|
|London, United Kingdom, E1 1BB|
|Principal Investigator:||Elizabeth Ball, PhD||Barts & The London NHS Trust|