A Smartphone App for Women With Primary Dysmenorrhea (smartAID)

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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Self-care information feature; Other: Self-acupressure feature

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 Type: Interventional
• Enrollment (Anticipated): 594
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Pach, MD; Phone Number: 004930450529068; Email: daniel.pach@charite.de
• Study Contact Backup: Name: Iris Bartsch; Phone Number: 004930450529132; Email: iris.bartsch@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charite - Universitatsmedizin Berlin
    • Contact: Daniel Pach, MD; Phone Number: 030450529027; Email: luna-studie@charite.de
    • Contact: Email: luna-studie@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complete app; 198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.	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.
Active Comparator: Control intervention I; 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.	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.
Active Comparator: Control intervention II; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Responder	Responder defined as having at least 50% pain reduction on the days with pain	Daily during menstruation (1st to 12th menstrual cycles)
Number of days with pain (duration of pain)	Number of days participants reported pain.	Daily during menstruation (1st to 12th menstrual cycles)
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)
Days with pain medication	Days with intake of pain medication for menstrual pain during each menstruation	Daily during menstruation (1st to 12th menstrual cycles)
Adverse reaction	Characteristics of adverse reaction	End of menstruation (1st to 12th menstrual cycles)
Severe adverse events	Characteristics and duration of severe adverse events	End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)
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)
User satisfaction	User's satisfaction with app guided activity (NRS; 0=totally unsatisfied; 6=very satisfied)	End of menstruation (1st to 12th menstrual cycles)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Claudia M. Witt, MD, Charite University, Berlin, Germany; Principal Investigator: Daniel Pach, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Wang J, Rogge AA, Armour M, Smith CA, D'Adamo CR, Pischke CR, Yen HR, Wu MY, More AOO, Witt CM, Pach D. International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement. JMIR Mhealth Uhealth. 2020 Feb 11;8(2):e14661. doi: 10.2196/14661.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: self-management; mHealth; acupressure; self-care; dysmenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: smartAID-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No