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

NCT ID: NCT01582724

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Menstrual Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-care acupressure

1

Group Type: EXPERIMENTAL

Self-care acupressure at three predefined points

Intervention Type: 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

Usual care

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia M. Witt

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia M Witt, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 24499425 (View on PubMed)

Other Identifiers

AKUD-12

Identifier Type: -

Identifier Source: org_study_id