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

NCT ID: NCT06189300

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stoma Colostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telephone Education

Training and consultancy will be provided

Group Type EXPERIMENTAL

Education and counseling intervention

Intervention Type OTHER

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

Control

Standard care will be given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education and counseling intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Seyma Yurtseven

Clinic Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, Adana, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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5077606250

Identifier Type: -

Identifier Source: org_study_id

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