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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete app | Experimental | 198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Women with menstrual pain
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Pach, MD | Contact | 004930450529068 | daniel.pach@charite.de | |
| Iris Bartsch | Contact | 004930450529132 | iris.bartsch@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Claudia M. Witt, MD | Charite University, Berlin, Germany | Principal Investigator |
| Daniel Pach, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32058976 | Derived | 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. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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randomized, three-armed pragmatic study
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| 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. |
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| 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) |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |