Evidence map›Paper›PMID 32165549›Full record

Trial reportBMJ open2020

MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.

Gordon Forbes, Sian Newton, Clara Cantalapiedra Calvete, Judy Birch, Julie Dodds, Liz Steed, Carol Rivas, Khalid Khan, Frank Röhricht, Stephanie Taylor and 2 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02721108 nacompletednot on this map

Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain

TypeinterventionalSponsorQueen Mary University of LondonRan2016 to 2017Enrolled90ConditionsChronic Pelvic PainArmsMindfulness meditation, Relaxation app
NCT04773925 nacompletednot on this mapstarted 2021, after this paper: background citation

The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

TypeinterventionalSponsorMayo ClinicRan2021 to 2021Enrolled15ConditionsChronic Female Pelvic Pain Syndrome (Disorder)ArmsMindfulness counseling
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  6. Systematic Review for the Medical Applications of Meditation in Randomized Controlled Trials.International journal of environmental research and public health · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Gordon ForbesIoPPN, King's College London, London, UK.
Sian NewtonCentre for Primary Care and Population Health, Queen Mary University of London, London, UK.
Clara Cantalapiedra CalveteDepartment of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.
Judy BirchPelvic Pain Support Network, Poole, UK.
Julie DoddsWomen's Health Research Unit, Barts and The London School of Medicine and Dentistry, London, UK.
Liz SteedCentre for Primary Care and Population Health, Queen Mary University of London, London, UK.
Carol RivasFaculty of Health Sciences, University of Southampton, Southampton, UK.ORCID 0000-0002-0316-8090
Khalid KhanDepartment of Public Health, University of Granada, Granada, Spain.
Frank RöhrichtWolfson Institute of Preventive Medicine, Centre for Psychiatry, Queen Mary University of London, London, UK.
Stephanie TaylorCentre for Primary Care and Public Health, Queen Mary University of London, London, UK.
Brennan C KahanPragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
Elizabeth BallDepartment of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK elizabeth.ball9@nhs.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain.

designThree arm randomised feasibility trial.

settingWomen were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing.

participantsWomen were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised.

interventionsDaily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days. PRIMARY AND SECONDARY OUTCOME MEASURES: Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months.

resultsThe target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1).

conclusionsDespite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement. TRIAL REGISTRATION NUMBERS: NCT02721108; ISRCTN10925965; Results.

Indexed as

Mobile ApplicationsSmartphoneAdultChronic PainFeasibility StudiesFemaleFollow-Up StudiesHumansMeditationMindfulnessPatient CompliancePelvic PainRelaxation TherapySingle-Blind MethodTreatment Outcomechronic painmeditationmindfulnessmobile applicationspelvic painRandomised controlled trial

Identifiers

PMID32165549
PMCPMC7069270

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.