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NCT06189300

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

Completed NA Last updated 20 November 2025
What this trial tests

NA trial testing Education and counseling intervention in Stoma Colostomy in 66 participants. Completed in 30 September 2025.

Timeline
1 August 2024
Primary endpoint
1 December 2024
30 September 2025

Quick facts

Lead sponsorCukurova University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposehealth services research
Enrollment66
Start date1 August 2024
Primary completion1 December 2024
Estimated completion30 September 2025
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Cukurova University

Who can join

18 and older, any sex, with Stoma Colostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size was found to be high, and the statistical power of the study was calculated as 2.955. Therefore, the power level was set at 0.80. The sample size for each group was calculated as 30 using the G\*Power 3.1.9.7 program with an effect size of 0.8, 5% margin of error and 80% power %. Considering the possibility of data loss, the number of samples for each group was increased by 20% and it was planned to include 36 patients for each 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Stoma Colostomy

Currently open trials in the same condition.

Other Cukurova University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing