Mindfulness Meditation for Chronic Pelvic Pain Management

NCT02721108 | Completed

• 2 other identifiers: 010817QM10925965
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pelvic Pain

Keywords

Mindfulness; Headspace; Psychological approaches; Progressive muscle relaxation

Outcome Measures

Primary Outcomes (2)

• Duration of recruitment

  Length of time it will take to recruit 90 participant from the time recruitment starts

  6 months

• Patient adherence to app use

  first 8 weeks post-randomisation

Secondary Outcomes (12)

• 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

Study Arms (3)

Mindfulness: Group A

EXPERIMENTAL

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

Relaxation: Group B

ACTIVE COMPARATOR

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

Treatment as usual: Group C

NO INTERVENTION

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.

Interventions

Mindfulness meditation 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.

Mindfulness: Group A

Relaxation app 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.

Relaxation: Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• Headspace UK: collaborator

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32165549 DERIVED

• 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.

  PMID: 29335232 DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elizabeth Ball, PhD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: March 28, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2016-06

Locations

GB (1)