Clinical trial NCT03432611: A Smartphone App for Women With Primary Dysmenorrhea
Official title: Evaluation of a Smartphone Application for Self Care for Women With Menstrual Pain (Primary Dysmenorrhea): a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: mHealth
dysmenorrhea
acupressure
self-management
self-care
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2018-02-14
Enrollment: 594
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, three-armed pragmatic study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean pain intensity on the days with pain
timeFrame: Daily during the 6th menstruation after randomization
Secondary outcomes:
measure: Mean pain intensity on the days with pain
timeFrame: Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles)
measure: Responder
timeFrame: Daily during menstruation (1st to 12th menstrual cycles)
measure: Number of days with pain (duration of pain)
timeFrame: Daily during menstruation (1st to 12th menstrual cycles)
measure: Days with absence from work, training, or studies
timeFrame: Baseline, end of menstruation (1st to 12th menstrual cycles)
measure: Days with pain medication
timeFrame: Daily during menstruation (1st to 12th menstrual cycles)
measure: Adverse reaction
timeFrame: End of menstruation (1st to 12th menstrual cycles)
measure: Severe adverse events
timeFrame: End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)
measure: Frequency of acupressure application
timeFrame: 5 days before menstruation and during menstruation (1st to 12th menstrual cycles)
measure: User satisfaction
timeFrame: End of menstruation (1st to 12th menstrual cycles)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M. Witt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Daniel Pach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.