Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone (AKUD)
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ClinicalTrials.gov Identifier: NCT01582724 |
Recruitment Status
:
Completed
First Posted
: April 23, 2012
Last Update Posted
: August 4, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menstrual Pain | Procedure: Self-care acupressure at three predefined points | Not Applicable |
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 |
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
|
- 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 ]
- Worst pain intensity (NRS) [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
- Duration of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
- Responder rate defined as 50% pain reduction at the days of pain [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
- Sick leave days [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
- Adverse effects [ Time Frame: After 1., 2., 3. and 6. menstruation ]
- Days with medication intake [ Time Frame: Baseline, after the 1., 2., 3. and 6. menstruation ]
- Bodily self-efficacy [ Time Frame: Baseline, after 1.,2.,3. and 6. menstruation ]
- Credibility of the intervention [ Time Frame: After 3. menstruation ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582724
Germany | |
Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center | |
Berlin, Germany |
Principal Investigator: | Claudia M Witt, MD | Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |