A Smartphone App for Women With Primary Dysmenorrhea

NCT03432611 | Unknown

• 1 other identifier: smartAID-18
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

mHealth; dysmenorrhea; acupressure; self-management; self-care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean pain intensity on the days with pain

  Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles)

• Responder

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

• Number of days with pain (duration of pain)

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

• Days with absence from work, training, or studies

  Baseline, end of menstruation (1st to 12th menstrual cycles)

• Days with pain medication

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

Study Arms (3)

Complete app

EXPERIMENTAL

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; Other: Self-acupressure feature

Control intervention I

ACTIVE COMPARATOR

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

Control intervention II

ACTIVE COMPARATOR

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

Interventions

Self-care information feature OTHER

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.

Complete app; Control intervention I

Self-acupressure feature OTHER

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.

Complete app; Control intervention II

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Women with menstrual pain
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University of Zurich: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 32058976 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Claudia M. Witt, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Daniel Pach, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Pach, MD

CONTACT

004930450529068; daniel.pach@charite.de

Iris Bartsch

CONTACT

004930450529132; iris.bartsch@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: randomized, three-armed pragmatic study

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 14, 2018
• Study Start: February 19, 2018
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

DE (1)