Ostomy - Ileostomy or Colostomystoma-groupNCT07894757
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
A study testing Planned Group Interaction Program in people with Ostomy - Ileostomy or Colostomy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy
- What is being tested?
- Planned Group Interaction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and older.
- Individuals who have a temporary or permanent stoma.
- Individuals who volunteer to participate in the study and provide written informed consent.
Who cannot join
- Individuals with cognitive, psychiatric, or communication disorders that prevent them from participating in group interactions or completing the self-report questionnaires.
- Individuals with severe physical illnesses or acute complications that prevent them from attending the 5-week planned group sessions.
- Individuals who decline to participate or withdraw their consent during the study.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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).
Read the detailed description
Living with a stoma introduces significant physical, psychological, and social challenges that can adversely affect an individual's quality of life and self-efficacy in stoma care. Adapting to a stoma often requires comprehensive support and education beyond standard routine care. This non-randomized controlled interventional study aims to investigate the effects of a planned group interaction program on stoma adaptation, quality of life, and stoma care self-efficacy among individuals living with a stoma.
The study will be conducted with a targeted sample of 48 stoma patients, allocated evenly into an experimental group (n=24) and a control group (n=24) based on specific inclusion and exclusion criteria.
Participants assigned to the experimental group will engage in a structured "Planned Group Interaction" program. These interaction and education sessions will be held once a week, consistently on the same day and time, with each session lasting approximately 60 to 90 minutes over a consecutive 5-week period. The sessions will be systematically facilitated and guided by faculty members and nursing professionals from the research team.
The curriculum of the group interactions will cover essential topics directly impacting the patients' daily lives and stoma adaptation. Discussions will address physiological and psychological challenges, sexual health issues, strategies to facilitate participation in social activities, and the prevention and management of stoma-related complications. A primary mechanism of this intervention is the peer-to-peer dynamic; the sessions are actively designed to foster a supportive environment where participants can exchange ideas, share personal coping strategies, and discuss their lived experiences with others facing similar health conditions.
Participants in the control group will continue to receive their standard routine medical care and standard stoma education provided by their healthcare institution. They will not be exposed to the planned group interaction sessions.
Data collection will be conducted symmetrically for both groups at two main time points: at baseline (pre-test) immediately before the intervention period begins, and at the conclusion of the 5-week period (post-test). The baseline assessment will include a researcher-developed descriptive characteristics form detailing socio-demographic data and stoma-specific clinical history. Both the pre-test and post-test assessments will utilize validated psychometric scales to measure the core dimensions of the study: ostomy adaptation, quality of life, and stoma care self-efficacy.
- Conditions
- Ostomy - Ileostomy or Colostomy
- Being tested
- Planned Group Interaction Program
- Keywords
- ostomy, stoma, Group Interaction, Quality of Life, Self-Efficacy, Ostomy Adaptation, Stoma Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned Group Interaction ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Behavioral: Planned Group Interaction Program |
| Control Group | No intervention | Participants will continue to receive standard routine stoma care and standard education without attending any planned group interaction sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Pre-test) and Week 5 (Post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start5 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Eyikara, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894757
- Sponsor's protocol ID
- E-77082166-604.01-1410278
- Acronym
- stoma-group
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional ethics committee regulations regarding participant privacy and data protection.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
- ClinicalTrials.gov ID
- NCT07894757
- Acronym / sponsor ID
- stoma-group / E-77082166-604.01-1410278
- Conditions
- Ostomy - Ileostomy or Colostomy
- Keywords
- ostomy, stoma, Group Interaction, Quality of Life, Self-Efficacy, Ostomy Adaptation, Stoma Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Living with a stoma introduces significant physical, psychological, and social challenges that can adversely affect an individual's quality of life and self-efficacy in stoma care. Adapting to a stoma often requires comprehensive support and education beyond standard routine care. This non-randomized controlled interventional study aims to investigate the effects of a planned group interaction program on stoma adaptation, quality of life, and stoma care self-efficacy among individuals living with a stoma.
The study will be conducted with a targeted sample of 48 stoma patients, allocated evenly into an experimental group (n=24) and a control group (n=24) based on specific inclusion and exclusion criteria.
Participants assigned to the experimental group will engage in a structured "Planned Group Interaction" program. These interaction and education sessions will be held once a week, consistently on the same day and time, with each session lasting approximately 60 to 90 minutes over a consecutive 5-week period. The sessions will be systematically facilitated and guided by faculty members and nursing professionals from the research team.
The curriculum of the group interactions will cover essential topics directly impacting the patients' daily lives and stoma adaptation. Discussions will address physiological and psychological challenges, sexual health issues, strategies to facilitate participation in social activities, and the prevention and management of stoma-related complications. A primary mechanism of this intervention is the peer-to-peer dynamic; the sessions are actively designed to foster a supportive environment where participants can exchange ideas, share personal coping strategies, and discuss their lived experiences with others facing similar health conditions.
Participants in the control group will continue to receive their standard routine medical care and standard stoma education provided by their healthcare institution. They will not be exposed to the planned group interaction sessions.
Data collection will be conducted symmetrically for both groups at two main time points: at baseline (pre-test) immediately before the intervention period begins, and at the conclusion of the 5-week period (post-test). The baseline assessment will include a researcher-developed descriptive characteristics form detailing socio-demographic data and stoma-specific clinical history. Both the pre-test and post-test assessments will utilize validated psychometric scales to measure the core dimensions of the study: ostomy adaptation, quality of life, and stoma care self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Planned Group Interaction ProgramParticipants 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. |
| Control Group | No intervention | –Participants will continue to receive standard routine stoma care and standard education without attending any planned group interaction sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 years and older.
- Individuals who have a temporary or permanent stoma.
- Individuals who volunteer to participate in the study and provide written informed consent.
Key exclusion criteria (3 listed)
- Individuals with cognitive, psychiatric, or communication disorders that prevent them from participating in group interactions or completing the self-report questionnaires.
- Individuals with severe physical illnesses or acute complications that prevent them from attending the 5-week planned group sessions.
- Individuals who decline to participate or withdraw their consent during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planned Group Interaction ProgramA 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. | Behavioural | Experimental Group |
Primary outcome
Change in Ostomy Adaptation Score
Time frame: Baseline (Pre-test) and Week 5 (Post-test)
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.
Change in Stoma Quality of Life Score
Time frame: Baseline (Pre-test) and Week 5 (Post-test)
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.
Change in Stoma Care Self-Efficacy Score
Time frame: Baseline (Pre-test) and Week 5 (Post-test)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional ethics committee regulations regarding participant privacy and data protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned Group Interaction Program in people with Ostomy - Ileostomy or Colostomy, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ostomy Adaptation Score (time frame: Baseline (Pre-test) and Week 5 (Post-test)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.