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
1 Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin - Berlin, Luisenstraße 57, Berlin, D- 10117, Germany
2 Chengdu University of Traditional Chinese Medicine, Chengdu, China
3 International Society for Chinese Medicine (Societas Medicinae Sinensis, SMS), Munich, Germany
4 TCM practice Hamburg, Mamma Center Hamburg, Jerusalem Hospital, Hamburg, Germany
5 TCM gynecological practice Berlin, Berlin, Germany
6 University of Maryland School of Medicine, Center for Integrative Medicine, Baltimore, MD, USA
7 TCM practice, Berlin, Germany
8 Competitive Sports Center and College Berlin, Berlin, Germany
9 Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Essen, Germany
10 Sophie-Charlotte High School, Berlin, Germany
11 University of Traditional Chinese Medicine, Shanghai, China
12 School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Trials 2013, 14:99 doi:10.1186/1745-6215-14-99Published: 11 April 2013
Self-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.
The 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.
Stakeholder 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.
Stakeholder 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.