Mindfulness Meditation for Chronic Pelvic Pain Management

NCT ID: NCT02721108

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-03-31

Brief 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

Detailed Description

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.

The investigators decided to undertake a systematic review on the effect of mindfulness meditation and extend the search to other chronic pain conditions (e.g. back pain, headache, fibromyalgia and diabetic neuropathy) because previous systematic reviews had number of limitations, such as not reporting effect size. Two independent reviewers assessed the risk of bias systematically using Review Manager (RevMan) 5.2 software. Out of 472 citations 9 RCTs were finally included. Most studies were of moderate quality; sample sizes were generally small.

Mindfulness meditation had positive effects on depression in chronic pain patients (SMD -0.28; 95%CI -0.53, -0.03; p = 0.03). A trend in reduction of anxiety and affective pain and a trend towards better QUOL, especially the mental health component and better pain acceptance was observed. Only one of the included studies reported the important measure of pain acceptance. If a larger sample size had been available it would have been likely that this and other health outcomes would have shown significant improvements, as was seen in depression (which was studied on n=259 patients), rather than trends. It is the investigators intention to add results to the body of research from a future full-scale trial.

Currently Mindfulness-based treatment is creating lively research interest. Two recent systematic reviews report positive effects on somatisation disorders and psychological stress. Although there is no ongoing study on patients with CPP, other chronic diseases with strong psychological components of depression and anxiety such as COPD and the RFPB-funded pilot study PATHWAYS on Pulmonary Arterial Hypertension are underway.

Of particular interest, due to the similarities in study design to MEMPHIS, is a recently closed pilot study, MIMS (UKCRN ID 13105) that investigated adjustment to multiple sclerosis.

In MIMS meditation teaching was delivered by videoconference. Web-based delivery has also been explored and shown to be feasible for reducing stress, anxiety and depression; both options are lacking the flexibility of a smartphone app, which is being proposed. There is evolving work on care pathways through primary secondary and tertiary levels for patients with CPP and recently mindfulness meditation has been introduced in Dorset, albeit delivered face-to-face. This could be replaced by cheaper and more flexible app-delivered meditation training.

This study will address the knowledge gaps and provide by:

1. Providing feasibility data for a large multicentre RCT aimed at rigorously testing Mindfulness meditation in CPP

2. Establishing whether this app could be seamlessly integrated into CPP pathways

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Mindfulness meditation

Intervention Type: BEHAVIORAL

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.

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

Group Type: ACTIVE_COMPARATOR

Relaxation app

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Headspace UK

UNKNOWN

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ball, PhD

Role: PRINCIPAL_INVESTIGATOR

Barts & The London NHS Trust

Locations

Barts Health NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

Forbes G, Newton S, Cantalapiedra Calvete C, Birch J, Dodds J, Steed L, Rivas C, Khan K, Rohricht F, Taylor S, Kahan BC, Ball E. MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial. BMJ Open. 2020 Mar 12;10(3):e030164. doi: 10.1136/bmjopen-2019-030164.

Reference Type: DERIVED

PMID: 32165549 (View on PubMed)

Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.

Reference Type: DERIVED

PMID: 29335232 (View on PubMed)

Other Identifiers

10925965

Identifier Type: REGISTRY

Identifier Source: secondary_id

010817QM

Identifier Type: -

Identifier Source: org_study_id