Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study

Abstract

ObjectivesThe aim of the study was to explore women's motivations for participating in a clinical trial and to evaluate how financial compensation impacts women's explanations for participation.Design, setting and participantsSemistructured interviews were conducted face to face or by telephone with 25 of 220 women who participated in a pragmatic randomised trial for app-administered self-care acupressure for dysmenorrhoea (AKUD). Of these 25 women, 10 had entered AKUD knowing they would receive a financial compensation of €30. A purposive sampling strategy was used.ResultsWomen had a long history of seeking help and were unsatisfied with the options available, namely painkillers and oral contraceptives. While interviewees were open to painkillers, they were uneasy about taking them on a monthly basis. The AKUD trial offered the possibility to find an alternative solution. A second reason for participation was the desire to add a new treatment to routine medical care, for which the interviewees considered randomised trials a prerequisite. The financial incentive was a subsidiary motivation in the interviewees' narratives.ConclusionsOur results contribute to the ongoing discussion of the impact of financial compensation on research participants' assessment of risk. The interviewed women considered all research participants able to make their own choices regarding trial participation, even in the face of financial compensation or payment of study participants. Furthermore, the importance of clinical trials providing new treatments that could change medical practice might be an overlooked reason for trial participation and could be used in future recruitment strategies.

Feasibility and acceptability of a proposed trial of acupuncture as an adjunct to lifestyle interventions for weight loss in Polycystic Ovary Syndrome: a qualitative study

“…Many women supported the use of a sham control. This is consistent with previous research indicating that in general, participants of complementary therapy trials understand the need for RCTs and the value of the scientific method [ 37 , 38 ]. Knowledge of placeboes may be relatively high amongst the general public, with a UK-based survey conducted on participants recruited from the community indicating that 68% of respondents had heard of or read about placeboes [ 39 ].…”

Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness

“…Content-wise, the examined apps utilized a variety of interventions. One of the studies used an app with instructions for self-acupressure [59], one included an optical imaging tool [55], one a digital music intervention [51], one daily reminders along with supportive messages [52], two utilized a mix of app-guided physiotherapy exercises, mindfulness, and education [46,49,53], one employed self-help chats moderated by experts [50], and one app had a medication management option [56]. Of the 12 RCTs, only one compared their app-based intervention with an assessment only group [43].…”

“…Of the 12 RCTs, only one compared their app-based intervention with an assessment only group [43]. The other 11 RCTs compared their app-based intervention with active control groups that received either physiotherapy [46,47], educational reading material or other such information [36,40,42,44], recommendations to stay active [37,38], access to a self-help website [41,59], a wearable activity tracker without smartphone application [45], or unspecified treatment as usual with mail reminders to complete assessments [39]. A table with a detailed description of the app content can be found in the Supplementary file (See in Table S2).…”

Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial

“…5 Moreover, self-care treatments such as rest, medication, heating pads, tea, exercise, and herbs are already used by women with menstrual pain. 10 Therefore an additional nondrug and self-care treatment option might fit well into women's perceptions of how to treat menstrual pain 39 and might further support selfempowerment of affected women.…”