Status:
UNKNOWN
A Smartphone App for Women With Primary Dysmenorrhea
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University of Zurich
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
With a randomized, pragmatic study the effectiveness of a smartphone app for menstrual pain in 18-34-year-old women with primary dysmenorrhea will be investigated.
Detailed Description
Smartphone apps may be useful to guide and support individuals in self-management strategies. Primary dysmenorrhea is a very common problem for women. With a randomized, pragmatic study the investigat...
Eligibility Criteria
Inclusion
- Female, aged 18-34 years
- 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
- Known pregnancy
- Pregnancy already planned for the forthcoming 12 months
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT03432611
Start Date
February 19 2018
End Date
March 1 2021
Last Update
July 31 2019
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany