Not Yet RecruitingNot Applicable

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

66 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age ≥18 years Able to read and write Turkish Undergoing ostomy surgery for the first time Permanent ostomy or expected to remain for at least 6 months No major mental, physical, or communication impairment Owns an iOS/Android smartphone with active internet access Able to use mobile applications Uses WhatsApp for digital form submission during follow-up Exclusion Criteria: Receiving stoma-related education or counseling from another institution or professional during the study period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ostomy Adjustment Inventory (OAI) Total Score

Timeframe: Post-discharge Day 15, Month 1, Month 3, Month 6

Adaptation of Quality of Life Scale (AQLS) Total and Subscale Scores

Timeframe: Post-discharge Day 15, Month 1, Month 3, and Month 6

Trial details

NCT IDNCT07260539

SponsorGazi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01

Contact for this trial

FERZAN KALAYCI EMEK, RESEARCH Asistan

+905436540498 ferzan.kalayciemek@ksbu.edu.tr

View on ClinicalTrials.gov More Intestinal Stoma trials