Planning and design of an intervention study together with stakeholders
Scientists of the research group "Complementary and Integrative Medicine" of the Institute for Social Medicine, Epidemiology and Health Economics of the Charité have investigated the effect of self-acupressure on the reduction of menstrual pain. Affected young women and other relevant stakeholders were already involved in the planning of the study. Originally, the researchers had the idea of using a relaxation technique as well, but the co-researchers rejected this: They desired an intervention that was easy to apply by themselves and that did not take too much time, so that they could easily integrate it into their daily routine. In addition, an app should be available to give instructions for acupressure as well as to record the data.
Multiple methods of stakeholder engagement were used: A focus group discussion and a cross-sectional survey were conducted among female co-researchers and participants who were affected by menstrual pain. In addition, a stakeholder advisory group was implemented to design the study, for example the criteria of the intervention. According to these criteria (e.g. only including easy-to-find acupressure points), acupressure experts developed the intervention with a Delphi consensus method. During the process, it became clear how much the stakeholder engagement influenced the design. It allowed the study to be more user-oriented, which can favour higher adherence and follow-up rates. In the acupressure group, a reduction in pain intensity and medication intake during menstruation was observed after six months compared to a control group.
The study protocol was published in Trials (1) in collaboration with stakeholders who were also part of the author team. After completion, the results of the study were published in the American Journal of Obstetrics & Gynecology (2). Because of the promising results, the app was revised and is currently being investigated in an evaluation study with longer follow-up times (3).
The article „Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial“ (2) received a QUEST Award for Patient & Stakeholder Engagement.
(1) Blödt, S., Schützler, L., Huang, W., Pach, D., Brinkhaus, B., Hummelsberger, J., Kirschbaum, B., Kuhlmann, K., Lao, L., Liang, F., Mietzner, A., Mittring, N., Müller, S., Paul, A., Pimpao-Niederle, C., Roll, S., Wu, H., Zhu, J., Witt, C.M. (2013). Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol. Trials, 14, 99. doi: 10.1186/1745-6215-14-99.
(2) Blödt, S., Pach, D., Eisenhart-Rothe, S. v., Lotz, F., Roll, S., Icke, K., & Witt, C.M. (2018). Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial. American Journal of Obstetrics & Gynecology, 218(227), e1-9. doi: 10.1016/j.ajog.2017.11.570
(3) Wang J., Rogge A.A., Armour, M., Smith C.A., D’Adamo, C.R., Pischke, C.R., Yen, H.R., Wu, M.Y., Moré, A.O.O., Witt, C.M., & Pach, D. (2020). International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement. JMIR mHealth and uHealth, 8(2), e14661. doi: 10.2196/14661