NCT06406738

Brief Summary

The aim of this study is to determine the effects of using high-fidelity simulators in newborn first care training on the knowledge, skills, satisfaction and self-confidence of midwifery students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 6, 2024

Last Update Submit

July 7, 2024

Conditions

Newborn; Vitality

Outcome Measures

Primary Outcomes (1)

  • First Care of the Newborn Information Form

    t is a material developed by Karaçam Z, Çoban A, Taşpınar A (2018), consisting of 25 questions, to measure the student's knowledge level about newborn care. the minimum score is 0 and maximum score is 75.

    immediately before simulation and immediately after the training and 6 weeks later

Study Arms (2)

High Reality Simulator

EXPERIMENTAL

Newborn first-care 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 Newborn first-care. 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

NO INTERVENTION

Using model will perform Newborn first-care. 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.

Interventions

Using High Reality SimulatorOTHER

Using High Reality Simulator will perform newborn first-care.

Also known as: model
High Reality Simulator

Eligibility Criteria

Age18 Years - 35 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)

Sumeyye

Ilkadim, Samsun, 55100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Models, Biological

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Officials

  • Sumeyye BAL, Ph.D.

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 15, 2024

Primary Completion

June 29, 2024

Study Completion

June 30, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations

TU(1)