Extrait

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) [email protected] 2. Miss Elizabeth Ball (scientific) [email protected]

Critère d'inclusion

• Specialty: Reproductive health and childbirth, Primary sub-specialty: General gynaecology; UKCRC code/ Disease: Other/ Symptoms and signs involving the digestive system and abdomen

Liens

• ictrp
• isrctn