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Pilot Study to Investigate the Effect of a Dysmenorrhoea App

NCT06283225 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-01

No results posted yet for this study

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

Interventions

DEVICE

Pia-App

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.

Sponsors & Collaborators

  • Endo Health GmbH

    lead INDUSTRY

Principal Investigators

  • Nadine Rohloff, Dr. med. · Endo Health GmbH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-07-31
Completion
2024-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283225 on ClinicalTrials.gov