Published in:
Open Access
01-12-2013 | Research
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
Authors:
Susanne Blödt, Lena Schützler, Wenjing Huang, Daniel Pach, Benno Brinkhaus, Josef Hummelsberger, Barbara Kirschbaum, Kirsten Kuhlmann, Lixing Lao, Fanrong Liang, Anna Mietzner, Nadine Mittring, Sabine Müller, Anna Paul, Carolina Pimpao-Niederle, Stephanie Roll, Huangan Wu, Jiang Zhu, Claudia M Witt
Published in:
Trials
|
Issue 1/2013
Login to get access
Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
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.