Chronic Pelvic PainMEMPHISNCT02721108
Mindfulness Meditation for Chronic Pelvic Pain Management
A study testing Mindfulness meditation and Relaxation app in people with Chronic Pelvic Pain, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on women's 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Mindfulness meditation and Relaxation app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain
Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on women's 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.
Read more
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 participate/not 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
Read the 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 € 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
- Conditions
- Chronic Pelvic Pain
- Being tested
- Mindfulness meditation, Relaxation app
- Keywords
- Mindfulness, Headspace, Psychological approaches, Progressive muscle relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
The meditation content is a structured and progressive course, layering in new techniques and concepts over successive sessions. The course was created and narrated by a former monk - Andy Puddicombe - drawing on a secularised version of the techniques he was taught over 10 years' experience in monasteries around the world. The first 30 days cover basic techniques, assuming no previous experience of meditation. The second 30 days focus specifically on the use of these techniques with respect to pain. The duration of individual sessions builds over time. Days 1-10 are 10 minutes in duration, days 11-20 are 15 minutes in duration, and days 21-60 are 20 minutes in duration.
Relaxation appBehavioural
The Active Control group will use the same app, but the app will be configured so that they will hear a series of non-meditative progressive muscle relaxation instructions, also narrated by Andy Puddicombe. These sessions will be identical every day, except that their duration will increase to mirror the increasing duration of the meditation content being listened to by the Intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness: Group A | Experimental | Using a 60-day mindfulness instruction meditation app: 60 days of 10 and 20 minute long app modules with a spoken guide to mindfulness meditation, to be used once a day, including modules on the basics of mindfulness and a module targeted to pain, which can re-revisited until the end of the study Receives: Behavioral: Mindfulness meditation |
| Relaxation: Group B | Active comparator | Using comparison relaxation app with a series of non-meditative progressive muscle relaxation instructions: 60 days of 10 and 20 minute long app modules to be used once per day with spoken words and relaxing sounds, which can re-revisited until the end of the study Receives: Behavioral: Relaxation app |
| Treatment as usual: Group C | No intervention | No app: treatment as usual (watch and wait, medication and/or surgery) to investigate if any app intervention makes a difference to wellbeing and to ascertain dropout rates for the full-scale trial in patients who perceive that they are getting no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of recruitment
Length of time it will take to recruit 90 participant from the time recruitment starts
Measured: 6 months
Patient adherence to app use
Measured: first 8 weeks post-randomisation
Secondary outcomes (12)
Quality of life score-Physical Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-Social Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-Pain subscale (as measured by the RAND Short form Health Survey (SF-36)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-General Health subscale (as measured by the RAND Short form Health Survey (SF-36)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Depression score as measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Anxiety score (as measured by HADS)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Mindfulness score as measure by the Cognitive and Mindfulness - Revised (CAMS - R) scale
Measured: at 60 days, 3 months, and 6 months post-randomisation
Pain related disability score (as measured by the Chronic Pain Grade (CPG) disability subscale
Measured: at 60 days, 3 months, and 6 months post-randomisation
Self efficacy score (as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Pain acceptance score (as measured Chronic Pain Acceptance Questionnaire (CPAQ-8)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Sexual Health Outcomes score (as measured by Sexual Health Outcomes in Women Questionnaire (SHOW-Q)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Subjective outcome score (as measured by Measure Yourself Medical Outcome Profile (MYMOP)
Measured: at 60 days, 3 months, and 6 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Headspace UK
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ball, PhD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721108
- Sponsor's protocol ID
- 010817QM
- Other IDs
- 10925965
- Acronym
- MEMPHIS
- Status last verified
- Jun 2016
- First submitted
- 28 Sep 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: This is a feasibility study. data will be used to inform design of a full-scale trial.
Publications
Forbes G, Newton S, Cantalapiedra Calvete C, Birch J, Dodds J, Steed L, Rivas C, Khan K, Rohricht F, Taylor S, Kahan BC, Ball E. MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial. BMJ Open. 2020 Mar 12;10(3):e030164. doi: 10.1136/bmjopen-2019-030164.
PubMed 32165549Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
PubMed 29335232
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT02721108
- Acronym / sponsor ID
- MEMPHIS / 010817QM
- Conditions
- Chronic Pelvic Pain
- Keywords
- Mindfulness, Headspace, Psychological approaches, Progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Headspace UK
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on women's 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 participate/not 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 € 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness: Group A | Experimental | Behavioral: Mindfulness meditationUsing a 60-day mindfulness instruction meditation app: 60 days of 10 and 20 minute long app modules with a spoken guide to mindfulness meditation, to be used once a day, including modules on the basics of mindfulness and a module targeted to pain, which can re-revisited until the end of the study |
| Relaxation: Group B | Active comparator | Behavioral: Relaxation appUsing comparison relaxation app with a series of non-meditative progressive muscle relaxation instructions: 60 days of 10 and 20 minute long app modules to be used once per day with spoken words and relaxing sounds, which can re-revisited until the end of the study |
| Treatment as usual: Group C | No intervention | –No app: treatment as usual (watch and wait, medication and/or surgery) to investigate if any app intervention makes a difference to wellbeing and to ascertain dropout rates for the full-scale trial in patients who perceive that they are getting no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationThe meditation content is a structured and progressive course, layering in new techniques and concepts over successive sessions. The course was created and narrated by a former monk - Andy Puddicombe - drawing on a secularised version of the techniques he was taught over 10 years' experience in monasteries around the world. The first 30 days cover basic techniques, assuming no previous experience of meditation. The second 30 days focus specifically on the use of these techniques with respect to pain. The duration of individual sessions builds over time. Days 1-10 are 10 minutes in duration, days 11-20 are 15 minutes in duration, and days 21-60 are 20 minutes in duration. | Behavioural | Mindfulness: Group A |
| Relaxation appThe Active Control group will use the same app, but the app will be configured so that they will hear a series of non-meditative progressive muscle relaxation instructions, also narrated by Andy Puddicombe. These sessions will be identical every day, except that their duration will increase to mirror the increasing duration of the meditation content being listened to by the Intervention group. | Behavioural | Relaxation: Group B |
Primary outcome
Duration of recruitment
Time frame: 6 months
Length of time it will take to recruit 90 participant from the time recruitment starts
Patient adherence to app use
Time frame: first 8 weeks post-randomisation
12 secondary outcomes
Quality of life score-Physical Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-Social Functioning subscale (as measured by the RAND Short form Health Survey (SF-36)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-Pain subscale (as measured by the RAND Short form Health Survey (SF-36)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Quality of life score-General Health subscale (as measured by the RAND Short form Health Survey (SF-36)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Depression score as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Anxiety score (as measured by HADS)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Mindfulness score as measure by the Cognitive and Mindfulness - Revised (CAMS - R) scale
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Pain related disability score (as measured by the Chronic Pain Grade (CPG) disability subscale
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Self efficacy score (as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Pain acceptance score (as measured Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Sexual Health Outcomes score (as measured by Sexual Health Outcomes in Women Questionnaire (SHOW-Q)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Subjective outcome score (as measured by Measure Yourself Medical Outcome Profile (MYMOP)
Time frame: at 60 days, 3 months, and 6 months post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 32165549Forbes G, Newton S, Cantalapiedra Calvete C, Birch J, Dodds J, Steed L, Rivas C, Khan K, Rohricht F, Taylor S, Kahan BC, Ball E. MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial. BMJ Open. 2020 Mar 12;10(3):e030164. doi: 10.1136/bmjopen-2019-030164.
- Derived from this study: PubMed 29335232Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
- Individual participant dataSharing planned: Undecided. This is a feasibility study. data will be used to inform design of a full-scale trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Ball, PhD principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation and Relaxation app in people with Chronic Pelvic Pain, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of recruitment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721108, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.