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

This study is currently recruiting participants.
Verified January 2013 by Charite University, Berlin, Germany
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: January 18, 2013
Last verified: January 2013
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 ]

Estimated Enrollment: 220
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582724

Contacts
Contact: Claudia M Witt, MD +4930450529132 claudia.witt@charite.de

Locations
Germany
Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center Recruiting
Berlin, Germany
Contact: Susanne Bloedt, Dipl. Biol.     +4930450529026     susanne.bloedt@charite.de    
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

No publications provided

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: January 18, 2013
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
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013