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

Study Overview
=================
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.

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

Conditions
-----------------
Menstrual Pain

Intervention / Treatment
-----------------
* Procedure: Self-care acupressure at three predefined points


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-care acupressure<br>1 | Procedure: Self-care acupressure at three predefined points<br>* 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<br>|
| No Intervention: Usual care<br>2 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Days with medication intake |  | Baseline, after the 1., 2., 3. and 6. menstruation | 
| Bodily self-efficacy |  | Baseline, after 1.,2.,3. and 6. menstruation | 
| Credibility of the intervention |  | After 3. menstruation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menstrual pain, Primary dysmenorrhea, Self-care acupressure