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

This study is a single-blind, parallel-group randomized controlled trial designed to evaluate the effect of a mobile application-based education, counseling, and monitoring program on stoma adaptation and stoma-related quality of life in adults with a newly created ostomy.

The trial will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center in Ankara, Türkiye.

Participants and sample size: Adults (≥18 years) undergoing ostomy surgery for the first time and expected to have a permanent ostomy or an ostomy lasting ≥6 months will be screened. Additional inclusion criteria include Turkish literacy, no major mental/physical/communication barriers, ownership of an iOS/Android smartphone with internet access, ability to use mobile applications, and WhatsApp use for digital form submission.

Individuals receiving concurrent stoma education/counseling from another institution or professional during follow-up will be excluded.

Based on power analysis (mixed ANOVA, Cohen f=0.40, α=0.05, power=99.7%, r=0.50), a minimum of 60 participants is required; allowing for \~10% attrition, the target enrollment is 66 participants (1:1 allocation).

Randomization and masking: Participants will be randomized 1:1 to intervention (Group A) or control (Group B) using block randomization via SealedEnvelope.com. Eleven fixed blocks of six participants will be generated, with three participants assigned to each group per block.

Randomization will be performed by an independent person not involved in data collection. The trial is single-blind: participants will not be informed of their group assignment; researchers delivering the intervention will be unblinded.

Intervention: All participants will receive the unit's standard pre-discharge stoma education and routine follow-up guidance.

In the intervention group, the "Stomaterapi-M" mobile application will be installed on discharge day with researcher guidance. For six months, participants will access structured educational materials (text and videos), nurse counseling through in-app messaging and scheduled video appointments, and a planned monitoring module for symptom/complication tracking. Monitoring frequency is weekly during month 1, bi-weekly during month 2, and monthly during months 3-6, with reminder notifications sent before each planned entry.

Participants who miss three consecutive monitoring/counseling sessions, cannot actively use the app, withdraw consent, or submit incomplete outcome forms will be removed from the study.

Control: The control group will receive standard care only, including routine stomatherapy education, counseling, and clinic follow-ups. Outcomes will be collected digitally via

Outcome measures and timeline:

Primary outcomes are (1) stoma adaptation measured with the Ostomy Adjustment Inventory (OAI), and (2) stoma-related quality of life measured with the Adaptation of Quality of Life Scale (AQLS).

These outcomes will be assessed at post-discharge day 15 and at months 1, 3, and 6.

Secondary outcome is app usability measured with the Mobile Application Usability Scale (MAUS) in the intervention group at month 6.

To minimize loss to follow-up, reminder messages/notifications will be sent to both groups at each assessment point.

Data management and analysis: Participants will be coded as A/B without linking codes to personal identifiers. Analyses will follow the intention-to-treat principle.

Group×time effects on OAI and AQLS will be analyzed using mixed two-factor repeated measures ANOVA; non-parametric equivalents will be applied if assumptions are not met. Between-group comparisons at each time point will use independent samples t-test or Mann-Whitney U test, and within-group changes will use repeated measures ANOVA or Friedman test. Significance will be set at p\<0.05 (and p\<0.01 where appropriate).

Ethics and funding: Ethical approval has been obtained from the Gazi University Ethics Committee (Approval No. E-77082166-302.08.01-1018511) and institutional permission from Gazi University Health Research and Application Center.

Written informed consent will be obtained from all participants. The study is funded by Gazi University Scientific Research Projects (BAP) under grant TDK-2025-10011.

• Mobile Application Usability Scale (MAUS) Score [Time frame: Month 6 (intervention group only)]