Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
594 participants
INTERVENTIONAL
2018-02-19
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Complete app
198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.
Self-care information feature
The self-care feature offers information on self-care for menstrual pain. The following topics are shown: exercise, dietary supplementation, heating pad/hot water bottle, yoga, and information on when to consult a doctor and how primary dysmenorrhoea is often treated. Notifications from the app which can be deactivated remind women of surveys and activities.
Self-acupressure feature
The acupressure feature offers detailed written and multimedia descriptions of an acupressure used for menstrual pain. Three acupressure points are described, which should be massaged bilaterally twice a day up to five times a day on the 5 days before menstruation and during menstruation. Each point should be massaged for 2 minutes. A timer for the acupressure and notifications from the app which can be deactivated remind women of surveys and acupressure.
Control intervention I
198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-care information feature, but not the self-acupressure feature.
Self-care information feature
The self-care feature offers information on self-care for menstrual pain. The following topics are shown: exercise, dietary supplementation, heating pad/hot water bottle, yoga, and information on when to consult a doctor and how primary dysmenorrhoea is often treated. Notifications from the app which can be deactivated remind women of surveys and activities.
Control intervention II
198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-acupressure feature, but not the self-care information feature.
Self-acupressure feature
The acupressure feature offers detailed written and multimedia descriptions of an acupressure used for menstrual pain. Three acupressure points are described, which should be massaged bilaterally twice a day up to five times a day on the 5 days before menstruation and during menstruation. Each point should be massaged for 2 minutes. A timer for the acupressure and notifications from the app which can be deactivated remind women of surveys and acupressure.
Interventions
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Self-care information feature
The self-care feature offers information on self-care for menstrual pain. The following topics are shown: exercise, dietary supplementation, heating pad/hot water bottle, yoga, and information on when to consult a doctor and how primary dysmenorrhoea is often treated. Notifications from the app which can be deactivated remind women of surveys and activities.
Self-acupressure feature
The acupressure feature offers detailed written and multimedia descriptions of an acupressure used for menstrual pain. Three acupressure points are described, which should be massaged bilaterally twice a day up to five times a day on the 5 days before menstruation and during menstruation. Each point should be massaged for 2 minutes. A timer for the acupressure and notifications from the app which can be deactivated remind women of surveys and acupressure.
Eligibility Criteria
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Inclusion Criteria
* Dysmenorrhea, defined as self-reported menstrual cramps or pain during every menstrual cycle which started during the teenage years
* No prior history of a gynecological disease that is known to be a reason for the dysmenorrhea
* Not more than 5 days with menstrual pain outside the menstrual period itself
* Menstruation within the last six weeks and a cycle length of 3 to 6 weeks
* Moderate or severe pain, defined as a score equal to or higher than 6 on a numeric rating scale (NRS, 0 to 10) for the worst pain intensity during the last menstruation
* Informed consent
* Possession of an iPhone
* Willingness and ability to input and share anonymous data through the study app
* The willingness to see a doctor when 1) pain is getting worse than usual, 2) pain medication is not helping, and 3) when the pain is still present well before or well after the period.
Exclusion Criteria
* Pregnancy already planned for the forthcoming 12 months
18 Years
34 Years
FEMALE
No
Sponsors
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University of Zurich
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia M. Witt
Prof. Dr. med.
Principal Investigators
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Claudia M. Witt, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Daniel Pach, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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Wang J, Rogge AA, Armour M, Smith CA, D'Adamo CR, Pischke CR, Yen HR, Wu MY, More AOO, Witt CM, Pach D. International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement. JMIR Mhealth Uhealth. 2020 Feb 11;8(2):e14661. doi: 10.2196/14661.
Other Identifiers
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smartAID-18
Identifier Type: -
Identifier Source: org_study_id
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