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

NCT06189300 | Completed

• 1 other identifier: 5077606250
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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

Stoma Colostomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 and 3 mounth

Study Arms (2)

Telephone Education

EXPERIMENTAL

Training and consultancy will be provided

Other: Education and counseling intervention

Control

NO INTERVENTION

Standard care will be given

Interventions

Education and counseling intervention OTHER

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

Telephone Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having undergone stoma surgery in a university hospital,
• No vision or hearing problems,
• Verbal communication is possible,
• Without diagnosed psychiatric problems.

You may not qualify if:

• Want to leave the research

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Adana, 0101011, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status; Counseling

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Nurse

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

TU (1)