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.
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.


CONCLUSIONS
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.


BACKGROUND
Clinicaltrials.gov identifier http://NCT01582724.
Susanne
S
Blödt
Lena
L
Schützler
Wenjing
W
Huang
Daniel
D
Pach
Benno
B
Brinkhaus
Josef
J
Hummelsberger
Barbara
B
Kirschbaum
Kirsten
K
Kuhlmann
Lixing
L
Lao
Fanrong
F
Liang
Anna
A
Mietzner
Nadine
N
Mittring
Sabine
S
Müller
Anna
A
Paul
Carolina
C
Pimpao-Niederle
Stephanie
S
Roll
Huangan
H
Wu
Jiang
J
Zhu
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin - Berlin, Luisenstraße 57, Berlin, D- 10117, Germany. claudia.witt@charite.de.
Claudia M
CM
Witt
D019050:Acupressure; D000328:Adult; D002985:Clinical Protocols; D004412:Dysmenorrhea / Q000628:therapy*; D005260:Female; D006801:Humans; D012107:Research Design; D012648:Self Care; D013223:Statistics as Topic