Stoma ColostomyNCT06189300
The Effect of Education and Counseling Given to People With Stoma by Telephone on Stoma Compliance and Complications
A study testing Education and counseling intervention in people with Stoma Colostomy, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size calculated based on the preliminary data was 2.955, indicating a very large effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy
- What is being tested?
- Education and counseling intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Having undergone stoma surgery in a university hospital,
- No vision or hearing problems,
- Verbal communication is possible,
- Without diagnosed psychiatric problems.
Who cannot join
- Want to leave the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study
The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size calculated based on the preliminary data was 2.955, indicating a very large effect. Therefore, to obtain a more conservative sample size estimate, an effect size of 0.80 was used for the a priori power analysis, in accordance with Cohen's convention for a large effect size. The sample size was calculated using G*Power version 3.1.9.7, with a significance level of α = 0.05 and a statistical power (1 - β) of 0.85. Accordingly, the required sample size was determined as 30 participants per group. The Ostomy Adjustment Inventory and Pittman Ostomy Complication Severity Index will be completed. The scales will be collected for both groups on the first day, first month, and third month postoperatively. Patients were contacted five times postoperatively to provide education and counseling. SPSS will be used for data analysis.
- Conditions
- Stoma Colostomy
- Being tested
- Education and counseling intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and counseling interventionOther
In addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Education | Experimental | Training and consultancy will be provided Receives: Other: Education and counseling intervention |
| Control | No intervention | Standard care will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of education and counseling given to individuals with stoma on complications.
Pittman Ostomy Complication Severity Index will be used. This valid and reliable index was developed by Joyce Pittman in 2014 to evaluate the frequency and severity of complications developing in the early postoperative period during the follow-up period of individuals with a stoma. A higher total score indicates more serious ostomy complications. The lowest score that can be obtained from the scale is 0, while the highest score is 92.
Measured: 1 and 3 mounth
The effect of education and counseling given to individuals with stoma on stoma compliance.
Ostomy Adjustment Inventory will be used. The lowest score that can be obtained from the scale is 0, while the highest score is 92.This valid and reliable scale was developed to determine the adaptation levels of individuals with stoma. A high score from the scale means that compliance is high.
Measured: 1 and 3 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Yurtseven, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189300
- Sponsor's protocol ID
- 5077606250
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06189300
- Acronym / sponsor ID
- 5077606250
- Conditions
- Stoma Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Jan 2024 (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 study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size calculated based on the preliminary data was 2.955, indicating a very large effect. Therefore, to obtain a more conservative sample size estimate, an effect size of 0.80 was used for the a priori power analysis, in accordance with Cohen's convention for a large effect size. The sample size was calculated using G*Power version 3.1.9.7, with a significance level of α = 0.05 and a statistical power (1 - β) of 0.85. Accordingly, the required sample size was determined as 30 participants per group. The Ostomy Adjustment Inventory and Pittman Ostomy Complication Severity Index will be completed. The scales will be collected for both groups on the first day, first month, and third month postoperatively. Patients were contacted five times postoperatively to provide education and counseling. SPSS will be used for data analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Education | Experimental | Other: Education and counseling interventionTraining and consultancy will be provided |
| Control | No intervention | –Standard care will be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having undergone stoma surgery in a university hospital,
- No vision or hearing problems,
- Verbal communication is possible,
- Without diagnosed psychiatric problems.
Key exclusion criteria (1 listed)
- Want to leave the research
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 |
|---|---|---|
| Education and counseling interventionIn addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month. | Other | Telephone Education |
Primary outcome
The effect of education and counseling given to individuals with stoma on complications.
Time frame: 1 and 3 mounth
Pittman Ostomy Complication Severity Index will be used. This valid and reliable index was developed by Joyce Pittman in 2014 to evaluate the frequency and severity of complications developing in the early postoperative period during the follow-up period of individuals with a stoma. A higher total score indicates more serious ostomy complications. The lowest score that can be obtained from the scale is 0, while the highest score is 92.
The effect of education and counseling given to individuals with stoma on stoma compliance.
Time frame: 1 and 3 mounth
Ostomy Adjustment Inventory will be used. The lowest score that can be obtained from the scale is 0, while the highest score is 92.This valid and reliable scale was developed to determine the adaptation levels of individuals with stoma. A high score from the scale means that compliance is high.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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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 Education and counseling intervention in people with Stoma Colostomy, run by Cukurova 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of education and counseling given to individuals with stoma on complications. (time frame: 1 and 3 mounth). The study lists 2 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 4 Aug 2026.