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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Menstrual Pain	Procedure: Self-care acupressure at three predefined points	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone
Study Start Date :	December 2012
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Worst pain intensity (NRS) [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
2. Duration of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
3. Responder rate defined as 50% pain reduction at the days of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
4. Sick leave days [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
5. Adverse effects [ Time Frame: After 1., 2., 3. and 6. menstruation ]
6. Days with medication intake [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
7. Bodily self-efficacy [ Time Frame: Baseline, after 1.,2.,3. and 6. menstruation ]
8. Credibility of the intervention [ Time Frame: After 3. menstruation ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 25 Years (Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	April 23, 2012
Last Update Posted:	August 4, 2015
Last Verified:	August 2015

Keywords provided by Claudia M. Witt, 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