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

Abstract

BackgroundSelf-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement.MethodsThe study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design.ResultsStakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start.ConclusionStakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group.Trial registrationClinicaltrials.gov identifier http://NCT01582724

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

“…This qualitative study was nested in the AKUD trial,25 and was conducted by the Institute for Social Medicine, Epidemiology and Health Economics at the Charité—Universitätsmedizin Berlin. Qualitative, semi-structured interviews were conducted with trial participants after they had completed all questionnaires for the AKUD trial, in order to avoid influencing the results of AKUD.…”

“…The randomised pragmatic trial AKUD25 was set up to assess the effectiveness of self-acupressure supported by a smartphone app (intervention), compared to usual care (control group), for 220 women with menstrual pain (trial registered at clinicaltrials.gov under NCT01582724). All women received the AKUD app, which provided questionnaires, diaries and, for the women in the intervention group, guidance on self-acupressure.…”

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

“…We performed a 2-armed, randomized, pragmatic trial with a treatment duration and observation time of 6 menstruation cycles per woman. The design of the trial and the development of the smartphone app "AKUD" were shaped by stakeholder engagement (see previous publication 29 ). A statistician not involved in the study used "ranuni" random number generator of the SAS/STAT software version 9.2 (SAS Institute, Cary, NC) to generate the randomization list (1:1 ratio).…”

“…The trial was registered at clinicaltrials.gov (NCT01582724), and the study protocol was published. 29…”

“…The acupressure intervention (points, duration, setting) resulted from a written Delphi consensus with international acupuncture experts from China, Germany, and the United States. 29 The acupuncture points SP6 (Sanyinjiao), LI4 (Hegu), and LR3 (Taichong) were used on both sides. In the acupressure group, a health care professional introduced the acupressure based on the instruction of the app at the baseline visit ( Table 1).…”