CompletedNot Applicable

The Effect of Education and Counseling Given to People With Stoma by Telephone on Stoma Compliance and Complications

Turkey (Türkiye)66 participantsStarted 2024-08-01

Plain-language 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. 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.

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: * Having undergone stoma surgery in a university hospital, * No vision or hearing problems, * Verbal communication is possible, * Without diagnosed psychiatric problems. Exclusion Criteria: * Want to leave the research

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

The effect of education and counseling given to individuals with stoma on complications.

Timeframe: 1 and 3 mounth

The effect of education and counseling given to individuals with stoma on stoma compliance.

Timeframe: 1 and 3 mounth

Trial details

NCT IDNCT06189300

SponsorCukurova University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

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