A Smartphone App for Women With Primary Dysmenorrhea

Not Applicable

• Conditions: Primary Dysmenorrhea
• Interventions: Other: Self-care information feature; Other: Self-acupressure feature

• Registration Number: NCT03432611
• Lead Sponsor: Charite University, Berlin, Germany

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 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.

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-14
• Study Start: 2018-02-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-09
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 594

Inclusion Criteria

• 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 Criteria

• Known pregnancy
• Pregnancy already planned for the forthcoming 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete app	Self-care information feature	198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.
Control intervention I	Self-care information feature	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.
Complete app	Self-acupressure feature	198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.
Control intervention II	Self-acupressure feature	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.

Primary Outcome Measures

Name	Time	Method
Mean pain intensity on the days with pain	Daily during the 6th menstruation after randomization	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).

Secondary Outcome Measures

Name	Time	Method
Adverse reaction	End of menstruation (1st to 12th menstrual cycles)	Characteristics of adverse reaction
User satisfaction	End of menstruation (1st to 12th menstrual cycles)	User's satisfaction with app guided activity (NRS; 0=totally unsatisfied; 6=very satisfied)
Days with pain medication	Daily during menstruation (1st to 12th menstrual cycles)	Days with intake of pain medication for menstrual pain during each menstruation
Responder	Daily during menstruation (1st to 12th menstrual cycles)	Responder defined as having at least 50% pain reduction on the days with pain
Days with absence from work, training, or studies	Baseline, end of menstruation (1st to 12th menstrual cycles)	Days with absence from work or education because of menstrual pain during previous period.
Number of days with pain (duration of pain)	Daily during menstruation (1st to 12th menstrual cycles)	Number of days participants reported pain.
Severe adverse events	End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)	Characteristics and duration of severe adverse events
Frequency of acupressure application	5 days before menstruation and during menstruation (1st to 12th menstrual cycles)	Number of times acupressure was applied during each cycle
Mean pain intensity on the days with pain	Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles)	The mean pain intensity on the days with pain during the menstruation 1 to 5 and 7 to 12 after randomization using a numerical rating scale (NRS; 0=no pain; 10=strongest pain imaginable).

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany