NCT07788079

Brief Summary

The aim of this study is to examine the effect of ostomy care education-delivered to patients who have undergone ostomy surgery using the Teach-back method on patients' self-care ability, ostomy compliance, and anxiety levels.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 10, 2026

Last Update Submit

August 23, 2026

Conditions

Keywords

ostomyself care powerostomy adjustmentnursingTeach-back methodpatient education

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)

    Ostomy adjustment will be assessed using the Ostomy Adjustment Inventory-23 (OAI-23), a 23-item self-report scale. Each item is scored on a 5-point Likert scale from 0 to 4, with a total score ranging from 0 to 92. Higher scores indicate better adjustment to living with an ostomy. The outcome will be the change in the total OAI-23 score from baseline to 2 months after the intervention.

    Baseline and 2 months after the intervention

Secondary Outcomes (1)

  • SELF-CARE POWER-SELF-CARE POWER SCALE SCORE

    From baseline to 2 months after the intervention

Other Outcomes (1)

  • ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE

    From baseline to 2 months after the intervention

Study Arms (1)

Who Have Undergone Ostomy Surgery

OSTOMY CARE EDUCATION APPLIED WİTH TEACH-BACK METHOD TO OSTOMY OPENED INDIVIDUALS ON SELF-CARE POWER OSTOMY ADJUSTMENT AND ANXIETY

Behavioral: TEACH BACK METHOD

Interventions

Providing Ostomy Education to Individuals Who Have Undergone Ostomy Surgery Using the "Teach-Back" Method

Who Have Undergone Ostomy Surgery

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-84 with ostomies who are hospitalized in the General Surgery Clinic at Sultan Abdulhamid II Han Training and Research Hospital, Health Sciences University

You may qualify if:

  • Having an ostomy
  • Being between 18 and 84 years of age
  • Speaking Turkish
  • Being literate
  • Voluntarily participating in the study
  • Having no hearing, visual, or mental disabilities
  • Being well-oriented to person, place, and time

You may not qualify if:

  • Having a poor general health condition
  • Having a neurological disorder
  • Having a psychiatric disorder
  • Providing incomplete responses to the study scales

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

IleusIntestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Şeyma Arslan

    Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 26, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS

Shared Documents
ICF

Locations