A Smartphone App for Women With Primary Dysmenorrhea

Last updated: July 30, 2019
Sponsor: Charite University, Berlin, Germany
Overall Status: Active - Recruiting

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Severe Premenstrual Symptom

Menstrual Disorders

Treatment

N/A

Clinical Study ID

NCT03432611
smartAID-18
  • Ages 18-34
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female, aged 18-34 years

  • Dysmenorrhea, defined as self-reported menstrual cramps or pain during every menstrualcycle which started during the teenage years

  • No prior history of a gynecological disease that is known to be a reason for thedysmenorrhea

  • 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 numericrating 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) painmedication is not helping, and 3) when the pain is still present well before or wellafter the period.

Exclusion

Exclusion Criteria:

  • Known pregnancy

  • Pregnancy already planned for the forthcoming 12 months

Study Design

Total Participants: 594
Study Start date:
February 19, 2018
Estimated Completion Date:
March 31, 2021

Study 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 investigators aim to evaluate whether a smartphone app for women with menstrual pain is effective in reducing menstrual pain in 18-34-year-old women with primary dysmenorrhea. For this the investigators compare the complete smartphone app with two control versions of this app. The complete app provides evidence-based self-care information and instructions for self-acupressure in menstrual pain, the control intervention I includes self-care information, but no instructions for self-acupressure, and control intervention II includes instructions for self-acupressure, but no self-care information. The investigators aim to observe 594 women with primary dysmenorrhea over 12 menstruation cycles. The primary outcome is the mean pain intensity on the days with pain during the 6th menstruation after randomization using a numerical rating scale (NRS; 0=no pain; 10=strongest pain imaginable). Women are eligible when they suffer from primary dysmenorrhea, are between 18 and 34 years old, not pregnant and do not plan to be pregnant within the next 12 months.

Connect with a study center

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

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