Mindfulness meditation for chronic pelvic pain management

• Register: ISRCTN
• Last refreshed on: 6 April 2020
• Main ID: ISRCTN10925965
• Date of registration: 28/06/2016
• Prospective Registration: No
• Primary sponsor: Barts Health NHS Trust
• Public title: Mindfulness meditation for chronic pelvic pain management
• Scientific title: Mindfulness meditation using a smart-phone application for women with chronic pelvic pain (MEMPHIS)
• Date of first enrolment: 13/05/2016
• Target sample size: 90
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10925965
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment, Psychological & Behavioural (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Elizabeth Ball

• Name: Sian Newton

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 or over
2. Women with organic and non-organic chronic pelvic pain lasting for six months or more
3. 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
4. Give written informed consent
5. Access to a personal computer or smartphone

Exclusion criteria:
1. Males
2. Absence of diagnosis of organic and non-organic chronic pelvic pain (CPP)
3. Diagnosis of organic and non-organic chronic pelvic pain (CPP) lasting for less than 3 months
4. Aged under 18 years
5. No access to a Personal computer or smart phone
6. Unable to speak / understand English

Added 28/10/2016:
7. Current users of the Headspace app content available to the public


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Specialty: Reproductive health and childbirth, Primary sub-specialty: General gynaecology; UKCRC code/ Disease: Other/ Symptoms and signs involving the digestive system and abdomen
Signs and Symptoms
Chronic pelvic pain (CPP)

Intervention(s)

Following provision of informed consent, patients will be randomised to one of three groups. Randomisation will be performed using a centralised internet service.

Group A - “Intervention”: Participants receive access to a smartphone app delivering mindfulness instructions for 60 days.
Group B - “Active control”: Participants receive access to a smartphone app delivering muscle relaxation instructions for 60 days, in addition to usual care.
Group C - Treatment as usual: Participants receive usual care

Clinical outcome data will be collected at 60 days, 3 months and 6 months post randomisation. App usability data will be collected at 60 days for the intervention and active control groups.

Primary Outcome(s)

1. Recruitment rate is measured at the end of follow up
2. Adherence rate is measured using data provided by Headspace during the intervention (first 60 days)
3. Usability of the app measured using a questionnaire at 60 days post randomisation

Secondary Outcome(s)

Secondary outcome measures as of 02/12/2016:
1. Quality of life-Physical Functioning subscale measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
2. Quality of life-Social Functioning subscale measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
3. Quality of life-Pain subscale measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
4. Quality of life-General Health subscale measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
5. Depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 60 days, 3 months, and 6 months post-randomisation
6. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) at v60 days, 3 months, and 6 months post-randomisation
7. Pain Acceptance is measured using the Chronic Pain Acceptance Questionnaire (CPAQ-8) at baseline, 60 days, 3 months, and 6 months post-randomisation
8. Sexual health outcomes are measured using the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) at baseline, 60 days, 3 months, and 6 months post-randomisation

Original secondary outcome measures:
1. Quality of life is measured using the Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
2. Depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 60 days, 3 months, and 6 months post-randomisation
3. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) at v60 days, 3 months, and 6 months post-randomisation
4. Pain Acceptance is measured using the Chronic Pain Acceptance Questionnaire (CPAQ-8) at baseline, 60 days, 3 months, and 6 months post-randomisation
5. Sexual health outcomes are measured using the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) at baseline, 60 days, 3 months, and 6 months post-randomisation

Secondary ID(s)

NCT02721108

20814

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

London - Camden and Kings Cross Research Ethics Committee, 01/02/2016, ref: 15/LO/1967

Results

• Results available: Yes
• Date Completed: 31/08/2017