Ball Elizabeth, Newton Sian, Kahan Brennan C, Forbes Gordon, Wright Neil, Cantalapiedra Calvete Clara, Gibson Harry A L, Rogozinska Ewelina, Rivas Carol, Taylor Stephanie J C, Birch Judy, Dodds Julie
Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, United Kingdom.
Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
Female 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.
To 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.
Mindfulness 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.
Recruitment 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.
This 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.
ClinicalTrials.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).
女性慢性盆腔疼痛（CPP）被定义为女性间歇性或持续性盆腔或下腹部疼痛，持续至少6个月。据估计，全球多达四分之一的女性受CPP影响，在英国，它占妇科专科转诊病例的五分之一。心理干预被广泛应用。由于等待时间和资金能力阻碍了面对面咨询的机会，支持性自我管理（SSM）已成为一种可行的替代方案。正念冥想是一种潜在有价值的SSM工具，在移动技术时代，这可以通过智能手机应用程序提供给个体用户。
评估通过手机应用程序为CPP患者进行正念冥想干预试验的可行性。主要可行性目标是评估患者招募和应用程序依从性，获取用于未来试验样本量估计的信息，并获得关于应用程序可用性的反馈。
“慢性盆腔疼痛女性的正念冥想（MEMPHIS）”是一项三臂可行性试验，在英国的两家医院进行。符合条件的参与者按1:1:1的比例随机分配到三个治疗组之一：（1）干预组，由一个有引导语音的正念冥想应用程序组成；（2）积极对照组，由一个渐进性肌肉松弛应用程序组成；（3）常规护理组（无应用程序）。参与者随访6个月。关键可行性结果包括招募所有研究患者所需的时间、依从性以及用于后续全面试验样本量计算的估计值。在可行性试验完成后，我们将进行焦点小组讨论，以探讨应用程序的可用性和不依从的原因。
MEMPHIS的招募工作于2016年5月至2016年9月进行。该研究于2月关闭，报告于2017年10月26日提交给英国国家卫生研究院。
这项可行性试验将为一项大型多中心试验的设计提供信息，以评估通过智能手机应用程序进行正念冥想治疗CPP的临床效果。
ClinicalTrials.gov：NCT02721108；https://clinicaltrials.gov/ct2/show/NCT02721108（由WebCite存档于http://www.webcitation.org/6wLMAkuaU）；BioMed Central：ISRCTN10925965；https://www.isrctn.com/ISRCTN10925965（由WebCite存档于http://www.webcitation.org/6wLMVLuys）。
