Plain English Summary
Background and study aims
Chronic pelvic pain (CPP) in women is where pain is felt in the pelvic region (the area below the belly button and between the hips) for at least 6 months. It is a relatively common condition, affecting around one million women in the UK every year, which is often painful and disabling, putting a great deal of strain on women’s lives and the NHS. The exact cause of CPP can vary, making it very difficult to treat. Mindfulness is a psychological treatment that works by teaching people to accept the sensations and emotions in the present moment. This can help people to accept their pain, allowing them to focus on daily activities and improve their quality of life. This type of treatment often takes place in eight-week face-to-face courses, however recently, smartphone applications have been used to deliver this type of treatment. The aim of this study is to investigate the effectiveness of a mindfulness-based smartphone app in the treatment of CPP in women, in order to find out whether a large-scale study is possible.
Who can participate?
Adult women with CPP who have access to a smartphone.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive access a smartphone app delivering mindfulness instructions for 60 days. Those in the second group receive access to a smartphone app delivering muscle relaxation instructions for 60 days, in addition to usual care. Those in the third group receive usual care alone for 60 days. At the end of the study, the amount of participants that have been recruited and the amount of those who actively took part are recorded. In addition, participants who received the mindfulness app complete a questionnaire at 60 days about how user friendly the app is, and all participants complete a range of questionnaires at the start of the study, and then after 60 days, 3 months and 6 months, to measure their mental wellbeing, quality of life and acceptance of pain.
What are the possible benefits and risks of participating?
There are not expected to be any direct benefits or risks for participants taking part in this study.
Where is the study run from?
1. Royal London Hospital (UK)
2. Whipps Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2015 to August 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Miss Sian Newton (public)
s.newton@qmul.ac.uk
2. Miss Elizabeth Ball (scientific)
Elizabeth.Ball@bartshealth.nhs.uk
Trial website
http://www.blizard.qmul.ac.uk/research-project/1368-memphis2.html
Contact information
Type
Public
Primary contact
Miss Sian Newton
ORCID ID
http://orcid.org/0000-0001-8035-0411
Contact details
Women’s Health Research Unit
Centre for Primary Care and Population Health
Blizard Institute
Barts and The London School of Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
Whitechapel
London
E1 2AB
United Kingdom
+44 (0)20 7882 5883
s.newton@qmul.ac.uk
Type
Scientific
Additional contact
Miss Elizabeth Ball
ORCID ID
http://orcid.org/0000-0001-8739-090X
Contact details
Gynaecology Department
Royal London Hospital
Whitechapel High Street
London
E1 1BB
United Kingdom
+44 (0)7501 980269
Elizabeth.Ball@bartshealth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02721108
Protocol/serial number
20814
Study information
Scientific title
Mindfulness meditation using a smart-phone application for women with chronic pelvic pain (MEMPHIS)
Acronym
Study hypothesis
The overall aim is to assess the feasibility of implementing a trial using psychological approaches delivered by a mobile phone app for patients with chronic pelvic pain (CPP).
The primary objectives are:
1. To provide feasibility data for a large multicentre RCT aimed at rigorously testing psychological approaches in CPP
2. To determine whether this app can be seamlessly integrated into clinical practice, especially CPP pathways
Ethics approval
London - Camden and Kings Cross Research Ethics Committee, 01/02/2016, ref: 15/LO/1967
Study design
Randomised; Interventional; Design type: Treatment, Psychological & Behavioural
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Reproductive health and childbirth, Primary sub-specialty: General gynaecology; UKCRC code/ Disease: Other/ Symptoms and signs involving the digestive system and abdomen
Intervention
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.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/11/2015
Overall trial end date
31/08/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 90; UK Sample Size: 90
Participant 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
Recruitment start date
13/05/2016
Recruitment end date
20/09/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom
Trial participating centre
Whips Cross Hospital
Whipps Cross Road
Leytonstone
London
E11 1NR
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29335232