A Smartphone App for Women With Primary Dysmenorrhea

Charite University, Berlin, Germany594 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

594

Conditions

Primary Dysmenorrhea

Interventions

Self-care information featureOTHER

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 featureOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 34 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Daily during the 6th menstruation after randomization

Secondary Outcomes

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).

Time frame: 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

Time frame: Daily during menstruation (1st to 12th menstrual cycles)

Number of days with pain (duration of pain)

Number of days participants reported pain.

Time frame: 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.

Time frame: 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

Time frame: Daily during menstruation (1st to 12th menstrual cycles)

Adverse reaction

Characteristics of adverse reaction

Central Contacts

Daniel Pach, MD

CONTACT

004930450529068 daniel.pach@charite.de

Iris Bartsch

CONTACT

004930450529132 iris.bartsch@charite.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.