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

NCT01582724 | Completed

• 1 other identifier: AKUD-12
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Pain

Keywords

Menstrual pain; Primary dysmenorrhea; Self-care acupressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Worst pain intensity (NRS)

  Baseline, after the 1., 2., 3. and 6. menstruation

• Duration of pain

  Baseline, after the 1., 2., 3. and 6. menstruation

• Responder rate defined as 50% pain reduction at the days of pain

  Baseline, after the 1., 2., 3. and 6. menstruation

• Sick leave days

  Baseline, after the 1., 2., 3. and 6. menstruation

• Adverse effects

  After 1., 2., 3. and 6. menstruation

Study Arms (2)

Self-care acupressure

EXPERIMENTAL

1

Procedure: Self-care acupressure at three predefined points

Usual care

NO INTERVENTION

2

Interventions

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

Self-care acupressure

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

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

Berlin, Germany

Location

Related Publications (1)

• Blodt S, Schutzler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Muller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt CM. Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol. Trials. 2013 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.

  PMID: 24499425 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Claudia M Witt, MD

  Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 23, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

DE (1)