Mindfulness Meditation for Chronic Pelvic Pain Management

CPP affects up to 24% women worldwide accounts for 20% of UK gynaecological clinic referrals and has a considerable impact on patients' quality of life and their income. CPP costs the NHS € 3.3bn per year. Despite costly interventions CPP is often resistant to surgical and medical treatment. Multifactorial psychological and somatic causes require a multidimensional approach. Psychological and somatic causes require a multidimensional approach, which is not routinely offered in gynaecology clinics.

Randomized Control Trial (RCT-) evidence suggests that primary inclusion of psychological interventions may be superior to primary surgery. Although psychological treatment is provided across the NHS, mostly in the context of primary care Improving Access to Psychological

Therapies there are problems with capacity, waiting times and overall number of patients being able to access services. Alternatively, patient self-management (PSM) is now recognised as a tool empowering patients to cope better with their condition.

Mindfulness meditation is a potentially valuable PSM tool in CPP.

The investigators conducted a systematic search of literature (07/2013, updated 12/2013) and found no RCTs on mindfulness meditation in CPP. However, two small pilot trials, one in CPP and one in endometriosis patients with promising results.

The investigators decided to undertake a systematic review on the effect of mindfulness meditation and extend the search to other chronic pain conditions (e.g. back pain, headache, fibromyalgia and diabetic neuropathy) because previous systematic reviews had number of limitations, such as not reporting effect size. Two independent reviewers assessed the risk of bias systematically using Review Manager (RevMan) 5.2 software. Out of 472 citations 9 RCTs were finally included. Most studies were of moderate quality; sample sizes were generally small.

Mindfulness meditation had positive effects on depression in chronic pain patients (SMD -0.28; 95%CI -0.53, -0.03; p = 0.03). A trend in reduction of anxiety and affective pain and a trend towards better QUOL, especially the mental health component and better pain acceptance was observed. Only one of the included studies reported the important measure of pain acceptance. If a larger sample size had been available it would have been likely that this and other health outcomes would have shown significant improvements, as was seen in depression (which was studied on n=259 patients), rather than trends. It is the investigators intention to add results to the body of research from a future full-scale trial.

Currently Mindfulness-based treatment is creating lively research interest. Two recent systematic reviews report positive effects on somatisation disorders and psychological stress. Although there is no ongoing study on patients with CPP, other chronic diseases with strong psychological components of depression and anxiety such as COPD and the RFPB-funded pilot study PATHWAYS on Pulmonary Arterial Hypertension are underway.

Of particular interest, due to the similarities in study design to MEMPHIS, is a recently closed pilot study, MIMS (UKCRN ID 13105) that investigated adjustment to multiple sclerosis.

In MIMS meditation teaching was delivered by videoconference. Web-based delivery has also been explored and shown to be feasible for reducing stress, anxiety and depression; both options are lacking the flexibility of a smartphone app, which is being proposed. There is evolving work on care pathways through primary secondary and tertiary levels for patients with CPP and recently mindfulness meditation has been introduced in Dorset, albeit delivered face-to-face. This could be replaced by cheaper and more flexible app-delivered meditation training.

This study will address the knowledge gaps and provide by:

• Providing feasibility data for a large multicentre RCT aimed at rigorously testing Mindfulness meditation in CPP
• Establishing whether this app could be seamlessly integrated into CPP pathways

Inclusion criteria

• Women with diagnosis of organic and non-organic chronic pelvic pain (CPP) for six months or more
• Age ≥ 18 years
• Be 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

Exclusion criteria

• Males
• Absence of diagnosis of organic and non-organic chronic pelvic pain (CPP)
• Diagnosis of organic and non-organic chronic pelvic pain (CPP) lasting for less than 3 months
• Age < 18 years
• No access to a Personal computer or smart phone
• Unable to speak / understand English
• Current users of the app content available to the public