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Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone (AKUD)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
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
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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 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 |
Resource links provided by NLM:
Further study details as provided by Claudia M. Witt, 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 ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01582724
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):
| 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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017