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

Primary Purpose

Menstrual Pain

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Self-care acupressure at three predefined points

About this trial

This is an interventional treatment trial for Menstrual Pain focused on measuring Menstrual pain, Primary dysmenorrhea, Self-care acupressure

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-care acupressure

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)

Secondary Outcome Measures

Worst pain intensity (NRS)

Duration of pain

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

Sick leave days

Adverse effects

Days with medication intake

Bodily self-efficacy

Credibility of the intervention

Full Information

NCT ID

NCT01582724

First Posted

April 18, 2012

Last Updated

August 3, 2015

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01582724

Brief Title

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

Acronym

AKUD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menstrual Pain

Keywords

Menstrual pain, Primary dysmenorrhea, Self-care acupressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-care acupressure

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Self-care acupressure at three predefined points

Intervention Description

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 Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Worst pain intensity (NRS)

Time Frame

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

Title

Duration of pain

Time Frame

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

Title

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

Time Frame

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

Title

Sick leave days

Time Frame

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

Title

Adverse effects

Time Frame

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

Title

Days with medication intake

Time Frame

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

Title

Bodily self-efficacy

Time Frame

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

Title

Credibility of the intervention

Time Frame

After 3. menstruation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia M Witt, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Berlin

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24499425

Citation

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.

Results Reference

derived

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

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