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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01582724
Acronym
AKUD
Enrollment
220
Registered
2012-04-23
Start date
2012-12-31
Completion date
2015-03-31
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Pain

Keywords

Menstrual pain, Primary dysmenorrhea, Self-care acupressure

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.

Interventions

PROCEDURESelf-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

Sponsors

Karl and Veronica Carstens Foundation
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Duration of painBaseline, after the 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
Sick leave daysBaseline, after the 1., 2., 3. and 6. menstruation
Worst pain intensity (NRS)Baseline, after the 1., 2., 3. and 6. menstruation
Days with medication intakeBaseline, after the 1., 2., 3. and 6. menstruation
Bodily self-efficacyBaseline, after 1.,2.,3. and 6. menstruation
Credibility of the interventionAfter 3. menstruation
Adverse effectsAfter 1., 2., 3. and 6. menstruation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026