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Mindfulness Meditation for Chronic Pelvic Pain Management (MEMPHIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02721108
First Posted: March 28, 2016
Last Update Posted: September 20, 2017
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.
Collaborator:
Headspace UK
Information provided by (Responsible Party):
Queen Mary University of London
  Purpose

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 Intervention
Chronic Pelvic Pain Behavioral: Mindfulness meditation Behavioral: Relaxation app

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Actual Study Start Date: May 2016
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Males
  • 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
  Contacts and Locations
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): NCT02721108


Locations
United Kingdom
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Queen Mary University of London
Headspace UK
Investigators
Principal Investigator: Elizabeth Ball, PhD Barts & The London NHS Trust
  More Information

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02721108     History of Changes
Other Study ID Numbers: 010817QM
10925965 ( Registry Identifier: ISRCTN )
First Submitted: September 28, 2015
First Posted: March 28, 2016
Last Update Posted: September 20, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is a feasibility study. data will be used to inform design of a full-scale trial.

Keywords provided by Queen Mary University of London:
Mindfulness
Headspace
Psychological approaches
Progressive muscle relaxation

Additional relevant MeSH terms:
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms