A Smartphone App for Women With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

— smartAID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432611
• Other study ID #: smartAID-18
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: March 2021

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: Daniel Pach, MD
• Phone: 004930450529068
• Email: daniel.pach[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 594
• Est. completion date: March 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	University of Zurich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain intensity on the days with pain	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).	Daily during the 6th menstruation after randomization
Secondary	Mean pain intensity on the days with pain	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).	Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles)
Secondary	Responder	Responder defined as having at least 50% pain reduction on the days with pain	Daily during menstruation (1st to 12th menstrual cycles)
Secondary	Number of days with pain (duration of pain)	Number of days participants reported pain.	Daily during menstruation (1st to 12th menstrual cycles)
Secondary	Days with absence from work, training, or studies	Days with absence from work or education because of menstrual pain during previous period.	Baseline, end of menstruation (1st to 12th menstrual cycles)
Secondary	Days with pain medication	Days with intake of pain medication for menstrual pain during each menstruation	Daily during menstruation (1st to 12th menstrual cycles)
Secondary	Adverse reaction	Characteristics of adverse reaction	End of menstruation (1st to 12th menstrual cycles)
Secondary	Severe adverse events	Characteristics and duration of severe adverse events	End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)
Secondary	Frequency of acupressure application	Number of times acupressure was applied during each cycle	5 days before menstruation and during menstruation (1st to 12th menstrual cycles)
Secondary	User satisfaction	User's satisfaction with app guided activity (NRS; 0=totally unsatisfied; 6=very satisfied)	End of menstruation (1st to 12th menstrual cycles)