Clinical Trials Directory

Trials / Completed

CompletedNCT06189300

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

The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Cukurova University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHEREducation and counseling interventionIn addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month.

Timeline

Start date
2024-08-01
Primary completion
2024-12-01
Completion
2025-09-30
First posted
2024-01-03
Last updated
2025-11-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06189300. Inclusion in this directory is not an endorsement.