DysmenorrheaNCT06283225
Pilot Study to Investigate the Effect of a Dysmenorrhoea App
A study testing Pia-App in people with Dysmenorrhea, run by Endo Health GmbH.
Trial summary
The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Pia-App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jul 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal capacity
- Resident in Germany
- Female
- Age ≥18 years of age
- Known and medically confirmed dysmenorrhoea
- Ownership of an internet-enabled mobile phone and ability to use it
Show all 12Show fewer
- Internet access for the app application and questionnaire
- Answering email address for registration
- Willingness to complete questionnaires online
- Motivation to use the app regularly
- Sufficient knowledge of the German language
- Absence of exclusion criteria
Who cannot join
- Pregnancy existing at the time of interview
- Gynaecological abdominal surgery planned in the next 12 weeks or gynaecological abdominal surgery performed within the last 8 weeks before study start
- Previous or existing access to the Endo app or other comparable digital health applications or current active prescription
- Current participation in other clinical studies
- Non-compliance with inclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Investigate the Influence of a Dysmenorrhoea App on the Quality of Life and Symptoms of Patients
The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants.
Read the detailed description
The pilot study aims to investigate the effect of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. Dysmenorrhoea, defined as painful menstruation, is a widespread and distressing health problem that can significantly affect the quality of life and well-being of affected women. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the dysmenorrhoea app over a 12-week period in addition to usual care (intervention group) or only usual care as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints, which were completed at T0 (baseline) and after 4 (T1), 8 (T2) and 12 weeks (T3).
The DSI, MDQ, VAS pain, FSS, FESS, PDI and DASS-21 questionnaires are defined as endpoints. The difference between the intervention group and the control group is compared in terms of the changes (change score) between the time points T0 (baseline) and T3 (post-treatment: twelve weeks). The aim was to show the superiority of the intervention. The evaluation was carried out additionally at the time points T0 and T1 (4 weeks after the start of the study) and T0 and T2 (8 weeks after the start of the study).
The hypotheses for the individual endpoints are defined as follows, whereby the respective hypothesis is to be analysed using an ANCOVA with baseline values as covariates:
Null hypothesis (H0): There is no difference between the intervention group and the control group.
Alternative hypothesis (HA): There is a difference between the intervention and control group.
In addition, this study should provide important insights for the planning of future studies. This includes aspects such as the selection of suitable endpoints, hypothesis formation and statistical analysis methods.
The planned duration of the study is expected to be seven months, starting in February 2024 and ending in August 2024. The study intends to enrol between 100 and 200 participants, aiming for an adequate sample size to ensure statistically significant results.
Overall, this pilot study is expected to provide important insights into whether and to what extent a dysmenorrhoea app can have a positive impact on the quality of life and symptoms of women with dysmenorrhoea. These results may not only help to improve patient care, but also lay the foundation for further research activities in the field of digital health applications and gynaecological health.
- Conditions
- Dysmenorrhea
- Being tested
- Pia-App
- Keywords
- digital, app, dysmenorrhea, quality of life
- Medical subject headings
- Dysmenorrhea, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pia-AppDevice
The dysmenorrhoea app (Pia-App) is evidence-based and helps patients to implement continuous multimodal (pain) treatment that is integrated into everyday life. Symptoms, events, influencing factors and examinations can be recorded in a specialised diary. Diary evaluations and learning modules on dysmenorrhoea and other relevant topics promote understanding of the condition and self-efficacy. An intelligent evaluation suggests suitable evidence-based and appropriate exercises. In the learning modules, patients can learn about the menstrual cycle, menstrual pain and self-management methods in a structured way. For example, there are structured courses on physiotherapy, yoga, stress reduction and relaxation methods such as progressive muscle relaxation and autogenic training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | the intervention group has access to the dysmenorrhoea app and its functions in addition to normal regular care. Receives: Device: Pia-App |
| Control group | No intervention | the intervention group has access to normal regular care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrhea Symptom Interference Scale (DSI)
Questionnaire
Measured: 12 weeks
Moos Menstrual Distress Questionnaire, Form C (MDQ)
Questionnaire
Measured: 12 weeks
Visual analog scale (VAS)
Questionnaire
Measured: 12 weeks
Depression Anxiety Stress Scale mit 21 Items (DASS-21)
Questionnaire
Measured: 12 weeks
German Version of Pain Self-Efficacy Questionnaire (FESS)
Questionnaire
Measured: 12 weeks
Fatigue Severity Scale (FSS)
Questionnaire
Measured: 12 weeks
Pain Disability Index (PDI)
Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group and control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endo Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadine Rohloff, Dr. med., Principal investigator, Endo Health GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283225
- Sponsor's protocol ID
- RCT004_PilotPia
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing of individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Influence of a Dysmenorrhoea App on the Quality of Life and Symptoms of Patients
- ClinicalTrials.gov ID
- NCT06283225
- Acronym / sponsor ID
- RCT004_PilotPia
- Conditions
- Dysmenorrhea
- Keywords
- digital, app, dysmenorrhea, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Endo Health GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants.
Detailed description
The pilot study aims to investigate the effect of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. Dysmenorrhoea, defined as painful menstruation, is a widespread and distressing health problem that can significantly affect the quality of life and well-being of affected women. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the dysmenorrhoea app over a 12-week period in addition to usual care (intervention group) or only usual care as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints, which were completed at T0 (baseline) and after 4 (T1), 8 (T2) and 12 weeks (T3).
The DSI, MDQ, VAS pain, FSS, FESS, PDI and DASS-21 questionnaires are defined as endpoints. The difference between the intervention group and the control group is compared in terms of the changes (change score) between the time points T0 (baseline) and T3 (post-treatment: twelve weeks). The aim was to show the superiority of the intervention. The evaluation was carried out additionally at the time points T0 and T1 (4 weeks after the start of the study) and T0 and T2 (8 weeks after the start of the study).
The hypotheses for the individual endpoints are defined as follows, whereby the respective hypothesis is to be analysed using an ANCOVA with baseline values as covariates:
Null hypothesis (H0): There is no difference between the intervention group and the control group.
Alternative hypothesis (HA): There is a difference between the intervention and control group.
In addition, this study should provide important insights for the planning of future studies. This includes aspects such as the selection of suitable endpoints, hypothesis formation and statistical analysis methods.
The planned duration of the study is expected to be seven months, starting in February 2024 and ending in August 2024. The study intends to enrol between 100 and 200 participants, aiming for an adequate sample size to ensure statistically significant results.
Overall, this pilot study is expected to provide important insights into whether and to what extent a dysmenorrhoea app can have a positive impact on the quality of life and symptoms of women with dysmenorrhoea. These results may not only help to improve patient care, but also lay the foundation for further research activities in the field of digital health applications and gynaecological health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Pia-Appthe intervention group has access to the dysmenorrhoea app and its functions in addition to normal regular care. |
| Control group | No intervention | –the intervention group has access to normal regular care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Legal capacity
- Resident in Germany
- Female
- Age ≥18 years of age
- Known and medically confirmed dysmenorrhoea
Key exclusion criteria (5 listed)
- Pregnancy existing at the time of interview
- Gynaecological abdominal surgery planned in the next 12 weeks or gynaecological abdominal surgery performed within the last 8 weeks before study start
- Previous or existing access to the Endo app or other comparable digital health applications or current active prescription
- Current participation in other clinical studies
- Non-compliance with inclusion criteria
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 |
|---|---|---|
| Pia-AppThe dysmenorrhoea app (Pia-App) is evidence-based and helps patients to implement continuous multimodal (pain) treatment that is integrated into everyday life. Symptoms, events, influencing factors and examinations can be recorded in a specialised diary. Diary evaluations and learning modules on dysmenorrhoea and other relevant topics promote understanding of the condition and self-efficacy. An intelligent evaluation suggests suitable evidence-based and appropriate exercises. In the learning modules, patients can learn about the menstrual cycle, menstrual pain and self-management methods in a structured way. For example, there are structured courses on physiotherapy, yoga, stress reduction and relaxation methods such as progressive muscle relaxation and autogenic training. | Device | Intervention group |
Primary outcome
Dysmenorrhea Symptom Interference Scale (DSI)
Time frame: 12 weeks
Questionnaire
Moos Menstrual Distress Questionnaire, Form C (MDQ)
Time frame: 12 weeks
Questionnaire
Visual analog scale (VAS)
Time frame: 12 weeks
Questionnaire
Depression Anxiety Stress Scale mit 21 Items (DASS-21)
Time frame: 12 weeks
Questionnaire
German Version of Pain Self-Efficacy Questionnaire (FESS)
Time frame: 12 weeks
Questionnaire
Fatigue Severity Scale (FSS)
Time frame: 12 weeks
Questionnaire
Pain Disability Index (PDI)
Time frame: 12 weeks
Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. There will be no sharing of individual participant data to other researchers.
Related trials for Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
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.
Nadine Rohloff, Dr. med. principal investigator
Endo Health GmbH
Questions about this trial
What is this clinical trial studying?
A study testing Pia-App in people with Dysmenorrhea, run by Endo Health GmbH.
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 12 inclusion and 5 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Nadine Rohloff, Dr. med. (+491789888896, nadine@endometriose.app), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysmenorrhea Symptom Interference Scale (DSI) (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.