A Smartphone App for Women With Primary Dysmenorrhea (smartAID)

Charité University Medicine Berlin

Status: Unknown

Conditions: Primary Dysmenorrhea

Treatments: Other: Self-care information feature; Other: Self-acupressure feature

Study type: Interventional

Funder types: Other

Identifiers

NCT03432611

smartAID-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 594 estimated patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

594 participants in 3 patient groups

Complete app

Experimental group

Description:

198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.

Treatment:

Other: Self-care information feature

Other: Self-acupressure feature

Control intervention I

Active Comparator group

Description:

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.

Treatment:

Other: Self-care information feature

Control intervention II

Active Comparator group

Description:

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.

Treatment:

Other: Self-acupressure feature