NCT03432611

A Smartphone App for Women With Primary Dysmenorrhea

Evaluation of a Smartphone Application for Self Care for Women With Menstrual Pain (Primary Dysmenorrhea): a Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Primary Dysmenorrhea

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2018-02-19
• Primary completion: 2020-09-01
• Completion: 2021-03-01
• First posted: 2018-02-14
• Last updated: 2019-07-31

Locations

1 site across 1 country: Germany