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 Blödt,Nadine Mittring,Barbara Kirschbaum,Kirsten Kuhlmann,Sabine Müller,Carolina Pimpao-Niederle,Benno Brinkhaus,Jiang Zhu,Daniel Pach,Wenjing Huang,Anna Paul,Josef Hummelsberger,Stephanie Roll,Lena Schützler,Huangan Wu,Anna Mietzner,Fanrong Liang,Lixing Lao,Claudia M Witt

doi:10.1186/1745-6215-14-99

Abstract

BackgroundSelf-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.MethodsThe 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.ResultsStakeholder 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.ConclusionStakeholder 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 registrationClinicaltrials.gov identifier http://NCT01582724

Highlights

Self-care acupressure might be successful in treating menstrual pain, which is common among young women
The purpose of this article is to provide our practical experience with stakeholder engagement in designing a pragmatic study and to present the subsequent study which investigates the effectiveness of additional selfcare acupressure for women with menstrual pain compared to usual care alone
Design of the main study The study will be a two-armed, randomized pragmatic trial investigating the effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone

Summary

Introduction

Self-care acupressure might be successful in treating menstrual pain, which is common among young women. 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. Primary dysmenorrhea with an estimated prevalence of 43% to 90% is one of the most common health problems among women younger than 25 years [1] and one of the main reasons for short-term school [2] or work absence, resulting in a significant economic loss [3]. Acupuncture is widely used by patients suffering from pain [6,7], and a pragmatic trial came to the conclusion that additional acupuncture was associated with improvements in pain and quality of life when compared to usual care alone in women with dysmenorrhea [8]. Studies have been small and self-care acupressure has been investigated only in two studies from Taiwan [11] and from Iran [12]

Objectives

Methods

Results

Discussion

Conclusion