Mindfulness Meditation for Chronic Pelvic Pain Management

Summary

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

Conditions

• Chronic Pelvic Pain

Interventions

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.

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.

Sponsors & Collaborators

• Headspace UK

  collaborator UNKNOWN

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Elizabeth Ball, PhD · Barts & The London NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2017-03-31

Completion

2017-03-31

Countries

• United Kingdom

Study Locations