MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.
Study Goal
The researchers aimed to evaluate the feasibility of a randomized trial testing a modified mindfulness meditation smartphone app for women with chronic pelvic pain, comparing it to an active control (muscle relaxation) and usual care.
Results Summary
The study found extremely low adherence to the mindfulness app (mean use: 1.8 days), with clinical outcomes showing no significant benefit over usual care or active control. Despite successful recruitment and follow-up rates, the low engagement suggested a definitive trial with this app was not warranted.
Population
Women over 18 with chronic pelvic pain (organic or non-organic) lasting ≥6 months, recruited from UK gynaecology clinics.
Effective Dosage
Daily mindfulness meditation via app (specific duration/frequency not detailed beyond 60-day intervention).
Duration
60 days
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
mindfulness meditation smartphone app | decrease | app use | women with chronic pelvic pain | mean app use 1.8 days | extremely low adherence | #1 |
active control app (muscle relaxation techniques) | decrease | app use | women with chronic pelvic pain | mean app use 7.0 days | extremely low adherence | #2 |
mindfulness meditation app | no change | pain acceptance scores | women with chronic pelvic pain | mean difference -2.3 (95% CI: -6.6 to 2.0) vs usual care | consistent with no benefit | #3 |
mindfulness meditation app | no change | pain acceptance scores | women with chronic pelvic pain | mean difference -4.0 (95% CI: -8.1 to 0.1) vs active control | consistent with no benefit | #4 |
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.