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Obstetrics and gynaecology
Original research
MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial
  1. Gordon Forbes1,
  2. Sian Newton2,
  3. Clara Cantalapiedra Calvete3,
  4. Judy Birch4,
  5. Julie Dodds5,
  6. Liz Steed2,
  7. Carol Rivas6,
  8. Khalid Khan7,
  9. Frank Röhricht8,
  10. Stephanie Taylor9,
  11. Brennan C Kahan10,
  12. Elizabeth Ball3
  1. 1 IoPPN, King's College London, London, UK
  2. 2 Centre for Primary Care and Population Health, Queen Mary University of London, London, UK
  3. 3 Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK
  4. 4 Pelvic Pain Support Network, Poole, UK
  5. 5 Women’s Health Research Unit, Barts and The London School of Medicine and Dentistry, London, UK
  6. 6 Faculty of Health Sciences, University of Southampton, Southampton, UK
  7. 7 Department of Public Health, University of Granada, Granada, Spain
  8. 8 Wolfson Institute of Preventive Medicine, Centre for Psychiatry, Queen Mary University of London, London, UK
  9. 9 Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
  10. 10 Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK
  1. Correspondence to Dr Elizabeth Ball; elizabeth.ball9{at}nhs.net

Abstract

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

Design Three arm randomised feasibility trial.

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

Participants Women 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.

Interventions Daily 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.

Results The 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).

Conclusions Despite 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.

  • chronic pain
  • meditation
  • mindfulness
  • mobile applications
  • pelvic pain
  • Randomised controlled trial
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-030164

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    Footnotes

    • Twitter @ClaraClaraeCC, @wirebird50

    • Contributors EB conceived the research and lead the study. GF conducted the statistical analysis under the supervision of BCK. GF drafted the manuscript. GF, SN, CCC, JB, JD, LS, CR, KK, FR, ST, BCK and EB contributed to the design and conducted the study, and discussed and reviewed the final manuscript.

    • Funding This research was supported by the UK National Institute of Health Research, Research for Patient Benefit programme (RfPB PB-PG-1013-32025).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval Ethics approval was granted by Camden and Kings Cross Research Ethics Committee on 1 February 2016.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. Anonymised participant data are available upon reasonable request. Please contact pctu-data-sharing@qmul.ac.uk with any data sharing requests.

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