stoma-group
Sponsor study identifier
interventional
48
1 country
1
Study Start
January 5, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to evaluate the effect of planned group interaction on ostomy adaptation, quality of life, and stoma care self-efficacy in adult individuals (aged 18 and older) living with a stoma. The main questions it aims to answer are: Does planned group interaction improve ostomy adaptation levels in individuals with a stoma? Does planned group interaction positively affect the quality of life in individuals with a stoma? Does planned group interaction positively affect stoma care self-efficacy in individuals with a stoma? Researchers will compare a control group receiving routine care and education to an experimental group receiving the intervention to see if planned group interactions lead to better adaptation, higher quality of life, and increased self-efficacy. Participants will: Attend weekly planned group interaction and education sessions lasting 60-90 minutes for a total of 5 weeks (Experimental group only). Engage in guided group discussions, under the supervision of faculty members and nurses, to share experiences and learn about physical, psychosocial, and sexual issues, as well as complications related to living with a stoma (Experimental group only). Continue to receive their routine stoma care and standard education without attending group sessions (Control group). Complete a set of questionnaires, including a Descriptive Characteristics Form, Ostomy Adjustment Inventory, Stoma Quality of Life Scale, and Stoma Self-Efficacy Scale, at the beginning of the study (pre-test) and at the end of the 5-week period (post-test).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2026
Actual (reported)October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Ostomy Adaptation Score
Evaluated using the "Ostomy Adjustment Inventory" (or Stoma Adaptation Scale). Items are scored on a 0-4 point Likert scale. Higher scores indicate better psychological and social adaptation to the stoma.
Baseline (Pre-test) and Week 5 (Post-test)
Change in Stoma Quality of Life Score
Evaluated using the "Stoma Quality of Life Scale". The scale consists of 19 items rated on a 5-point Likert scale. Higher total scores indicate a better quality of life for the individual.
Baseline (Pre-test) and Week 5 (Post-test)
Change in Stoma Care Self-Efficacy Score
Evaluated using the "Stoma Self-Efficacy Scale". It consists of 22 items and two subscales. Higher scores reflect higher self-efficacy and confidence in managing stoma care.
Baseline (Pre-test) and Week 5 (Post-test)
Participants will attend a 5-week planned group interaction program (60-90 minutes per week) to discuss physical, psychosocial, and sexual issues, and share experiences under the guidance of healthcare professionals.
Participants will continue to receive standard routine stoma care and standard education without attending any planned group interaction sessions.
A 5-week structured program consisting of weekly 60-90 minute group sessions. Facilitated by faculty members and nurses, these sessions involve peer interactions, experience sharing, and education regarding physical, psychosocial, and sexual issues related to living with a stoma, as well as strategies to facilitate social activities and manage complications.
Gazi University
Ankara, Turkey (Türkiye)
48 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
January 5, 2026
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
Individual participant data will not be shared due to institutional ethics committee regulations regarding participant privacy and data protection.
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Source: ClinicalTrials.gov.
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