NCT06103643

Brief Summary

The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 19, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

October 19, 2023

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Confidence/Efficacy Scale in Patient Intervention

    It was developed by Jekins in America in 1983 for nursing students. The scale is used to describe students' perceptions of clinical decision-making based on their own statements (Jenkins, 2001).It was adapted into Turkish by Durmaz-Edeer and Sarıkaya (2015). The sub-dimensions of the scale, which consists of 40 items and four sub-dimensions; "Exploring options and ideas", "Inquiring into goals and values", "Evaluating consequences", and "Searching for information and impartially adopting new information". Each subscale consists of 10 items. The total score of the scale is between 40 and 200, and each subscale is scored between 10 and 50. There is no cutoff point on the scale. A high score from the scale indicates that the perception of decision-making is high, and a low score indicates that the perception of decision-making is low.The scale is evaluated based on each subscale and scale total score (Jenkins, 2001).

    immediately before simulation and immediately after the training 2 months later

Study Arms (2)

High Reality Simulator

EXPERIMENTAL

Breech birth management training will be given by the responsible investigator, and then one of the groups will be allocated by randomization. Using High Reality Simulator will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Other: Using High Reality Simulator

control group

SHAM COMPARATOR

Using model will perform emergency breech birth. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Other: Using High Reality Simulator

Interventions

Using High Reality Simulator will perform emergency breech birth.

Also known as: model
High Reality Simulatorcontrol group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Agreeing to participate in the research and obtaining written permission,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Models, Biological

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Officials

  • Sümeyye BAL

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 27, 2023

Study Start

October 25, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations