Primary DysmenorrheasmartAIDNCT03432611
A Smartphone App for Women With Primary Dysmenorrhea
A study testing Self-care information feature and Self-acupressure feature in people with Primary Dysmenorrhea, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Self-care information feature and Self-acupressure feature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2018to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Known pregnancy
- Pregnancy already planned for the forthcoming 12 months
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Daniel Pach, MD, 030450529027, luna-studie@charite.de
luna-studie@charite.de
About this study
Official title: Evaluation of a Smartphone Application for Self Care for Women With Menstrual Pain (Primary Dysmenorrhea): a Randomized Trial
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Self-care information feature, Self-acupressure feature
- Keywords
- mHealth, dysmenorrhea, acupressure, self-management, self-care
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Complete app | Experimental | 198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature. Receives: 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. Receives: 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. Receives: Other: Self-acupressure feature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Daily during the 6th menstruation after randomization
Secondary outcomes (9)
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).
Measured: 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
Measured: Daily during menstruation (1st to 12th menstrual cycles)
Number of days with pain (duration of pain)
Number of days participants reported pain.
Measured: 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.
Measured: 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
Measured: Daily during menstruation (1st to 12th menstrual cycles)
Adverse reaction
Characteristics of adverse reaction
Measured: End of menstruation (1st to 12th menstrual cycles)
Severe adverse events
Characteristics and duration of severe adverse events
Measured: End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)
Frequency of acupressure application
Number of times acupressure was applied during each cycle
Measured: 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)
Measured: End of menstruation (1st to 12th menstrual cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start19 Feb 2018
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, three-armed pragmatic study
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M. Witt, MD, Principal investigator, Charite University, Berlin, GermanyDaniel Pach, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432611
- Sponsor's protocol ID
- smartAID-18
- Acronym
- smartAID
- Status last verified
- Jul 2019
- First submitted
- 18 Jan 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32058976
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smartphone Application for Self Care for Women With Menstrual Pain (Primary Dysmenorrhea): a Randomized Trial
- ClinicalTrials.gov ID
- NCT03432611
- Acronym / sponsor ID
- smartAID / smartAID-18
- Conditions
- Primary Dysmenorrhea
- Keywords
- mHealth, dysmenorrhea, acupressure, self-management, self-care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, three-armed pragmatic study
| Arm | Type | Receives |
|---|---|---|
| Complete app | Experimental | Other: Self-care information feature, Other: Self-acupressure feature198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature. |
| Control intervention I | Active comparator | Other: Self-care information feature198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-care information feature, but not the self-acupressure feature. |
| Control intervention II | Active comparator | Other: Self-acupressure feature198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-acupressure feature, but not the self-care information feature. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Known pregnancy
- Pregnancy already planned for the forthcoming 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-care information featureThe 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. | Other | Complete app, Control intervention I |
| Self-acupressure featureThe 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. | Other | Complete app, Control intervention II |
Primary outcome
Mean pain intensity on the days with pain
Time frame: Daily during the 6th menstruation after randomization
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).
9 secondary outcomes
Mean pain intensity on the days with pain
Time frame: Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles)
Responder
Time frame: Daily during menstruation (1st to 12th menstrual cycles)
Number of days with pain (duration of pain)
Time frame: Daily during menstruation (1st to 12th menstrual cycles)
Days with absence from work, training, or studies
Time frame: Baseline, end of menstruation (1st to 12th menstrual cycles)
Days with pain medication
Time frame: Daily during menstruation (1st to 12th menstrual cycles)
Adverse reaction
Time frame: End of menstruation (1st to 12th menstrual cycles)
Severe adverse events
Time frame: End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles)
Frequency of acupressure application
Time frame: 5 days before menstruation and during menstruation (1st to 12th menstrual cycles)
User satisfaction
Time frame: End of menstruation (1st to 12th menstrual cycles)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Derived from this study: PubMed 32058976Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M. Witt, MD principal investigator
Charite University, Berlin, Germany
Daniel Pach, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care information feature and Self-acupressure feature in people with Primary Dysmenorrhea, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Pach, MD (004930450529068, daniel.pach@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity on the days with pain (time frame: Daily during the 6th menstruation after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.