Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin - Berlin, Luisenstraße 57, Berlin, D- 10117, Germany.
Trials. 2013 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.
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.
Clinicaltrials.gov identifier http://NCT01582724.
自我穴位按压可能对治疗年轻女性常见的经期疼痛有效。需要进行具有利益相关者参与的比较有效性研究，在所有阶段都要努力满足决策者的需求。我们的目的是设计一项研究，比较单独常规护理与额外自我穴位按压对经期疼痛的效果，使用不同的利益相关者参与方法。
该研究采用多种混合方法进行利益相关者参与。基于调查和焦点小组讨论的结果，利益相关者咨询小组制定了研究设计。
利益相关者的参与促成了一项具有两臂的实用随机试验。将纳入 220 名年龄在 18 至 25 岁之间有经期疼痛的女性。使用特定于研究的移动应用程序（App）提供的电子问卷进行结果测量。主要结果将是治疗开始后第三次月经期间疼痛日的平均疼痛强度。
利益相关者的参与有助于制定出更能满足决策者需求的研究设计，包括将 App 作为一种现代工具，用于年轻目标群体的干预和数据收集。
Clinicaltrials.gov 标识符：http://NCT01582724。
