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

Stoma Colostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189300
• Other study ID #: 5077606250
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Cukurova University
• Contact: Seyma Yurtseven, Dr.
• Phone: +9005077606254
• Email: ssumer01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. Based on the f values of the methods to be studied in the literature review, the total sample size found using the GPOWER program with an effect size of 0.4 (Cohen), 90% power and 0.05% margin of error was found to be n = 44. The sample of the research was determined as 52 in this direction. "Informed Consent Form, State-Trait Anxiety Scale, Adaptation Scale for Individuals with Ostomies" will be filled out. Scales will be collected for both groups on postoperative day 1, day 15, and 1 month after surgery. The patients were called by phone on the 7th, 14th and 21st postoperative days and education and counseling services were provided. SPSS package program will be used to analyze the data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Colostomy

Intervention

Other:
• Education and counseling intervention
In addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 mounth
Primary	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 mounth