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Completed

NCT Number: NCT01582724

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-care acupressure at three predefined points

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Official study title

Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone

Acronym: AKUD

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 23, 2012
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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