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

Not Applicable
Completed
Conditions
Menstrual Pain
Interventions
Procedure: Self-care acupressure at three predefined points
Registration Number
NCT01582724
Lead Sponsor
Charite University, Berlin, Germany
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
220
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Self-care acupressureSelf-care acupressure at three predefined points1
Primary Outcome Measures
NameTimeMethod
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)3rd menstruation after therapy start
Secondary Outcome Measures
NameTimeMethod
Adverse effectsAfter 1., 2., 3. and 6. menstruation
Bodily self-efficacyBaseline, after 1.,2.,3. and 6. menstruation
Responder rate defined as 50% pain reduction at the days of painBaseline, after the 1., 2., 3. and 6. menstruation
Worst pain intensity (NRS)Baseline, after the 1., 2., 3. and 6. menstruation
Sick leave daysBaseline, after the 1., 2., 3. and 6. menstruation
Days with medication intakeBaseline, after the 1., 2., 3. and 6. menstruation
Duration of painBaseline, after the 1., 2., 3. and 6. menstruation
Credibility of the interventionAfter 3. menstruation

Trial Locations

Locations (1)

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

🇩🇪

Berlin, Germany

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