Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02721108
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2015-09-28
Brief Title:
Mindfulness Meditation for Chronic Pelvic Pain Management
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEMPHIS
Brief Summary:
Chronic pelvic pain CPP in women is common painful and disabling and puts much strain on womens lives and the National Health Service NHS
CPP may be related to internal organs the nervous system or psychological factors and is often difficult to treat Surgery and drugs have risks and side effects are expensive and do not help all patients
Psychological treatments have potential to improve CPP but are not consistently available Mindfulness meditation teaches people to accept their sensations and emotions in the present moment This can help to accept pain better which enables patients to focus on daily activities and improve their quality of life It has been shown to help in headache back pain and depression Usually mindfulness meditation is taught by attending courses for 8 weeks
The investigators want to find out in a full-scale trial if mindfulness meditation taught by using a smartphone app can help CPP patients
In preparation for this full-scale study the investigators will conduct the MEMPHIS study to answer the following questions
How many patients are willing to participate
How often they use the app
Reasons for not wanting to participatenot using the app -
- Which health questionnaires are the most useful ones
How many patients will be required for the full-scale trial
Patients will receive the usual treatment and be divided into three groups
using a 60-day mindfulness meditation app
-- using comparison app with progressive muscle relaxation but no meditation
no app
Patients will complete health questionnaires may be asked to comment in a focus group and record pain medication changes surgery and emergency medical visits
CPP may be related to internal organs the nervous system or psychological factors and is often difficult to treat Surgery and drugs have risks and side effects are expensive and do not help all patients
Psychological treatments have potential to improve CPP but are not consistently available Mindfulness meditation teaches people to accept their sensations and emotions in the present moment This can help to accept pain better which enables patients to focus on daily activities and improve their quality of life It has been shown to help in headache back pain and depression Usually mindfulness meditation is taught by attending courses for 8 weeks
The investigators want to find out in a full-scale trial if mindfulness meditation taught by using a smartphone app can help CPP patients
In preparation for this full-scale study the investigators will conduct the MEMPHIS study to answer the following questions
How many patients are willing to participate
How often they use the app
Reasons for not wanting to participatenot using the app -
- Which health questionnaires are the most useful ones
How many patients will be required for the full-scale trial
Patients will receive the usual treatment and be divided into three groups
using a 60-day mindfulness meditation app
-- using comparison app with progressive muscle relaxation but no meditation
no app
Patients will complete health questionnaires may be asked to comment in a focus group and record pain medication changes surgery and emergency medical visits
Detailed Description:
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 33bn 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 072013 updated 122013 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 eg 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 52 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 -028 95CI -053 -003 p 003 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 n259 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
1 Providing feasibility data for a large multicentre RCT aimed at rigorously testing Mindfulness meditation in CPP
2 Establishing whether this app could be seamlessly integrated into CPP pathways
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 072013 updated 122013 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 eg 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 52 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 -028 95CI -053 -003 p 003 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 n259 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
1 Providing feasibility data for a large multicentre RCT aimed at rigorously testing Mindfulness meditation in CPP
2 Establishing whether this app could be seamlessly integrated into CPP pathways
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10925965 | REGISTRY | ISRCTN | None |