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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06189300
Enrollment
66
Registered
2024-01-03
Start date
2024-08-01
Completion date
2025-09-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Colostomy

Brief 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.

Interventions

OTHEREducation and counseling intervention

In addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The effect of education and counseling given to individuals with stoma on complications.1 and 3 mounthPittman 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.1 and 3 mounthOstomy 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026