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
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- 作者：Susanne Bl?dt (1)
Lena Schützler (1)
Wenjing Huang (1) (2)
Daniel Pach (1)
Benno Brinkhaus (1)
Josef Hummelsberger (3)
Barbara Kirschbaum (4)
Kirsten Kuhlmann (5)
Lixing Lao (6)
Fanrong Liang (2)
Anna Mietzner (7)
Nadine Mittring (1)
Sabine Müller (8)
Anna Paul (9)
Carolina Pimpao-Niederle (10)
Stephanie Roll (1)
Huangan Wu (11)
Jiang Zhu (12)
Claudia M Witt (1) (6) - 关键词：Comparative effectiveness research ; Stakeholder engagement ; Acupressure ; Menstrual pain ; Smartphone application
- 刊名：Trials
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：14
- 期：1
- 全文大小：305KB
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Lena Schützler (1)
Wenjing Huang (1) (2)
Daniel Pach (1)
Benno Brinkhaus (1)
Josef Hummelsberger (3)
Barbara Kirschbaum (4)
Kirsten Kuhlmann (5)
Lixing Lao (6)
Fanrong Liang (2)
Anna Mietzner (7)
Nadine Mittring (1)
Sabine Müller (8)
Anna Paul (9)
Carolina Pimpao-Niederle (10)
Stephanie Roll (1)
Huangan Wu (11)
Jiang Zhu (12)
Claudia M Witt (1) (6)
1. Institute for Social Medicine, Epidemiology and Health Economics, Charité Universit?tsmedizin - Berlin, Luisenstra?e 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
文摘
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 NCT01582724