• Elizabeth Ball, Sian Newton, Brennan C Kahan, Gordon Forbes, Neil Wright, Clara Cantalapiedra Calvete, Harry A L Gibson, Ewelina Rogozinska, Carol Rivas, TaylorStephanie J CSJChttp://orcid.org/0000-0001-7454-6354Centre for Primary Care and Population Health, Queen Mary University of London, London, United Kingdom., Judy Birch, and Julie Dodds.
• Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, United Kingdom.
• JMIR Res Protoc. 2018 Jan 15; 7 (1): e8.

BackgroundFemale chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app.ObjectiveTo assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app.MethodsMindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance.ResultsRecruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017.ConclusionsThis feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP.Trial RegistrationClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).©Elizabeth Ball, Sian Newton, Brennan C Kahan, Gordon Forbes, Neil Wright, Clara Cantalapiedra Calvete, Harry A L Gibson, Ewelina Rogozinska, Carol Rivas, Stephanie J C Taylor, Judy Birch, Julie Dodds. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.01.2018.

6 keywords...

hide…