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NOT YET RECRUITING
NCT07260539
NA

Effect of a Mobile Application on Stoma Adaptation and Quality of Life

Sponsor: Gazi University

View on ClinicalTrials.gov

Summary

This single-blind, parallel-group randomized controlled trial aims to evaluate the effects of a mobile app-based education, counseling, and follow-up program on stoma adaptation and quality of life in adults with a newly ostomy. The study will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center (Ankara, Turkey). Participants meeting the inclusion criteria (n=66) will be assigned to intervention (mobile app support + standard care) and control (standard care only) groups in a 1:1 ratio via block randomization; participants will be kept unaware of their group assignment. Participants in the intervention group will download the "Stomatherapy-M" app on the day of discharge and will access structured educational content, receive nurse counseling (messaging and scheduled video calls), and share scheduled follow-up records regularly for six months. Follow-up frequency will be weekly in the first month, biweekly in the second month, and monthly in the following months. Primary outcomes; Adaptation to the stoma (Ostomy Adjustment Inventory) and stoma-related quality of life (Quality of Life Adaptation Scale) assessed at 15 days and 1, 3, and 6 months after discharge. App usability (MAUS) will be measured at 6 months only in the intervention group.

Official title: The Effect of Education, Counseling, and Monitoring Provided to Individuals With Stoma Via a Mobile Application on Adaptation to Stoma and Quality of Lif

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-01-01

Completion Date

2026-12-30

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Stomaterapi-M Mobile Application Support

Participants will use the "Stomaterapi-M" mobile application for 6 months starting on discharge day. The app provides structured stoma education (texts and videos), nurse counseling via in-app messaging and scheduled video calls, and a planned monitoring module. Monitoring frequency is weekly during month 1, bi-weekly during month 2, and monthly during months 3-6, with reminder notifications before each planned entry.