Pilot Study to Investigate the Effect of a Dysmenorrhoea App

NCT06283225 | Not Yet Recruiting DMC

• 1 other identifier: RCT004_PilotPia
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dysmenorrhea

Keywords

digital; app; dysmenorrhea; quality of life

Outcome Measures

Primary Outcomes (7)

• Dysmenorrhea Symptom Interference Scale (DSI)

  Questionnaire

  12 weeks

• Moos Menstrual Distress Questionnaire, Form C (MDQ)

  Questionnaire

  12 weeks

• Visual analog scale (VAS)

  Questionnaire

  12 weeks

• Depression Anxiety Stress Scale mit 21 Items (DASS-21)

  Questionnaire

  12 weeks

• German Version of Pain Self-Efficacy Questionnaire (FESS)

  Questionnaire

  12 weeks

• Fatigue Severity Scale (FSS)

  Questionnaire

  12 weeks

• Pain Disability Index (PDI)

  Questionnaire

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

the intervention group has access to the dysmenorrhoea app and its functions in addition to normal regular care.

Device: Pia-App

Control group

NO INTERVENTION

the intervention group has access to normal regular care only.

Interventions

Pia-App DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Health GmbH: lead

MeSH Terms

Conditions

Dysmenorrhea; Alzheimer Disease

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nadine Rohloff, Dr. med.

  Endo Health GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Rohloff, Dr. med.

CONTACT

+491789888896; nadine@endometriose.app

Teresa Götz, M. Sc.

CONTACT

+49 371 33560304; teresa@endometriose.app

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: intervention group and control group

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share