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Open Access 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

Susanne Blödt1, Lena Schützler1, Wenjing Huang12, Daniel Pach1, Benno Brinkhaus1, Josef Hummelsberger3, Barbara Kirschbaum4, Kirsten Kuhlmann5, Lixing Lao6, Fanrong Liang2, Anna Mietzner7, Nadine Mittring1, Sabine Müller8, Anna Paul9, Carolina Pimpao-Niederle10, Stephanie Roll1, Huangan Wu11, Jiang Zhu12 and Claudia M Witt16*

Author Affiliations

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

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Trials 2013, 14:99  doi:10.1186/1745-6215-14-99

Published: 11 April 2013

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.

Trial registration

Clinicaltrials.gov identifier http://NCT01582724 webcite

Keywords:
Comparative effectiveness research; Stakeholder engagement; Acupressure; Menstrual pain; Smartphone application