Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone (AKUD)

This study has been completed.

Sponsor:

Collaborator:

Karl and Veronica Carstens Foundation

Information provided by (Responsible Party):

Claudia M. Witt, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01582724

First received: April 18, 2012

Last updated: August 3, 2015

Last verified: August 2015

History of Changes

Purpose

The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.

Condition	Intervention
Menstrual Pain	Procedure: Self-care acupressure at three predefined points


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS) [ Time Frame: 3rd menstruation after therapy start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Worst pain intensity (NRS) [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: No ]
Duration of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: No ]
Responder rate defined as 50% pain reduction at the days of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: No ]
Sick leave days [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: After 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: Yes ]
Days with medication intake [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ] [ Designated as safety issue: No ]
Bodily self-efficacy [ Time Frame: Baseline, after 1.,2.,3. and 6. menstruation ] [ Designated as safety issue: No ]
Credibility of the intervention [ Time Frame: After 3. menstruation ] [ Designated as safety issue: No ]


Enrollment:	220
Study Start Date:	December 2012
Study Completion Date:	March 2015
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Self-care acupressure 1	Procedure: Self-care acupressure at three predefined points Self-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times
No Intervention: Usual care 2

Detailed Description:

Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.

Eligibility


Ages Eligible for Study:	18 Years to 25 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
Age: 18 to 25 years
Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
Written and oral informed consent
Women must be able to complete the baseline questionnaire in paper form, the electronic questionnaire via App and a electronic diary via App.
Presence of a Smartphone and agreement to do data entry through the App

Exclusion Criteria:

Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
Known or planned pregnancy in the next 8 months.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582724

Locations


Germany
Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center
Berlin, Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Karl and Veronica Carstens Foundation

Investigators


Principal Investigator:	Claudia M Witt, MD	Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blödt S, Schützler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Müller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt CM. 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. Trials. 2013 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.


Responsible Party:	Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01582724 History of Changes
Other Study ID Numbers:	AKUD-12
Study First Received:	April 18, 2012
Last Updated:	August 3, 2015
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:


Menstrual pain Primary dysmenorrhea Self-care acupressure

Additional relevant MeSH terms:


Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain	Pain Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016

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