NCT06397534

Brief Summary

This study is planned as a randomized controlled trial to determine the effect of education provided through the flipped learning model on students' levels of knowledge and self-efficacy regarding stoma care. The research will be conducted on 100 first-year nursing students between 05.2024-06.2024. Randomization will be ensured for students who meet the inclusion criteria, and they will be divided into two random groups: the experimental group (n=50) and the control group (n=50). All participating students will be administered the "Introductory Characteristics Form," "Stoma Care Knowledge Assessment Form (pre-test)," and "General Self-Efficacy Scale (pre-test)." For students in the experimental group, digital materials required for preparedness for the course based on the flipped learning model (such as course presentation materials and demonstration videos) will be prepared by the researchers. After the implementation and 4 weeks later, the 'Stoma Care Knowledge Assessment Form (post-test)' and the 'General Self-Efficacy Scale (post-test)' will be administered online. All students in the control group will be administered the 'Introductory Characteristics Form,' the 'Stoma Care Knowledge Assessment Form (pre-test),' and the 'General Self-Efficacy Scale (pre-test).' Subsequently, stoma care will be provided to the control group solely through traditional teaching methods. No additional resources will be provided. After the implementation and 4 weeks later, the 'Stoma Care Knowledge Assessment Form (post-test)' and the 'General Self-Efficacy Scale (post-test)' will be administered online.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet 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

First Submitted

Initial submission to the registry

April 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

April 30, 2024

Last Update Submit

January 16, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stoma Care Knowledge Evaluation Form

    This form includes 20 statements related to stoma care, such as what a stoma is, the characteristics of a stoma, emptying a stoma bag, changing a stoma bag, and skin care around the stoma. The statements were developed based on the literature (ASCN Stoma Care Clinical Guidelines 2016, Tuzer, Elbas, 2016). Each statement is evaluated on a 100-point scale, with options for "Correct," "Incorrect," and "I don't know." Correct responses are scored as 1, incorrect responses as 0, and the total score is calculated out of 100. 12 statements are correct and 8 statements are incorrect.

    just before education, just after education, just 1 month after education

  • General Self-Efficacy Scale

    The scale, developed by Sherer et al. (1982) and validated and reliability-tested in Turkish by Yıldırım and İlhan (2010), consists of three sub-dimensions and 17 items. The scale's sub-dimensions include "Starting" (items 2, 4, 5, 6, 7, 10, 11, 12, and 17; min-max: 9-45), "Persistence" (items 3, 13, 14, 15, and 16; min-max: 5-25), and "Effort Sustainment-Insistence" (items 1, 8, and 9; min-max: 3-15). The scale is a 5-point Likert-type scale, with response options ranging from "5: describes me very well" to "1: does not describe me at all" for each item. The scale includes 11 reverse-scored items (items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17). The maximum score that can be obtained from the scale is 85 and the minimum score is 17. An increase in score indicates an increase in self-efficacy belief.

    just before education, just after education, just 1 month after education

Study Arms (2)

Flipped Learning

EXPERIMENTAL

In the experimental group, students will be administered the "Introduction Characteristics Form," "Stoma Care Knowledge Assessment Form (pre-test)," and the "General Self-Efficacy Scale (pre-test)." Subsequently, digital materials (such as stoma care presentation materials and stoma care demonstration videos) will be prepared by the researchers. The video content will be uploaded to the 'Edpuzzle' program, which is accessible via internet connection or downloadable to devices. The video content in the 'Edpuzzle' program will consist of stoma care procedural steps. Following this, students will apply the "stoma care" skill in the skills laboratory under the supervision of instructors. To reinforce the implementation in the experimental group, online activities such as word clouds and quizzes will be sent. After the implementation and 4 weeks later, the 'Stoma Care Knowledge Assessment Form (post-test)' and the 'General Self-Efficacy Scale (post-test)' will be administered online.

Other: Education

Control

NO INTERVENTION

All students in the control group will be administered the 'Introductory Characteristics Form,' the 'Stoma Care Knowledge Assessment Form (pre-test),' and the 'General Self-Efficacy Scale (pre-test).' Subsequently, stoma care will be provided to the control group solely through traditional teaching methods. No additional resources will be provided. The stoma care topic will be taught to the control group for 2 hours theoretically and for 4 hours practically. Teaching in the control group will be conducted through PowerPoint presentations, question-and-answer sessions, demonstrations, and discussions. After the lesson, students will practice 'stoma care' in the skills laboratory under the supervision of instructors. After the implementation and 4 weeks later, the 'Stoma Care Knowledge Assessment Form (post-test)' and the 'General Self-Efficacy Scale (post-test)' will be administered online.

Interventions

In the experimental group, students will be administered the "Introduction Characteristics Form," "Stoma Care Knowledge Assessment Form (pre-test)," and the "General Self-Efficacy Scale (pre-test)." Subsequently, digital materials (such as stoma care presentation materials and stoma care demonstration videos) will be prepared by the researchers. The video content will be uploaded to the 'Edpuzzle' program, which is accessible via internet connection or downloadable to devices. The video content in the 'Edpuzzle' program will consist of stoma care procedural steps. Following this, students will apply the "stoma care" skill in the skills laboratory under the supervision of instructors. To reinforce the implementation in the experimental group, online activities such as word clouds and quizzes will be sent. After the implementation and 4 weeks later, the 'Stoma Care Knowledge Assessment Form (post-test)' and the 'General Self-Efficacy Scale (post-test)' will be administered online.

Flipped Learning

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First-year nursing students,
  • Volunteer to participate in the research,
  • Have smartphones/computers
  • Have continuous Internet Access

You may not qualify if:

  • Have previously studied in a health-related field
  • Have previously taken the fundamentals of nursing course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Tuba Yilmazer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ankara Yildirim Beyazit University

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 3, 2024

Study Start

January 17, 2025

Primary Completion

January 17, 2025

Study Completion

January 18, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share