NCT05999409

Brief Summary

The research; It is planned to evaluate the effectiveness of the use of simulation in the management of normal labor. The research was designed in a quasi-experimental randomized controlled type. The research is carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023 academic year. The sample of the study consists of all third-year students who enrolled in the Normal Birth and Postpartum Term course in the midwifery department for the first time (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year. These students are in the next 2022-2023 academic year. Registered for the Post Term Course). In the literature; In experimental studies, it has been reported that a sample size of at least 30 people is required in order to perform parametric tests (24). In this study, the number of students in the groups was determined as 32, considering that they may have lost. Students were divided into three groups as experimental (d1= High Reality simulator), (d2= Medium Reality simulator) group and control group (d3= slide and video presentation). The study is carried out with 96 students in total. The students who met the inclusion criteria were given a sequence number and then randomly divided into 3 groups using the https://www.randomizer.org online randomization program. Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

August 2, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • providing access to the number

    enough practice by students

    through study completion, an average of 9 month

Study Arms (3)

d1

EXPERIMENTAL

NBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.

Other: practice on birth simulator

d2

EXPERIMENTAL

An initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.

Other: practice on birth simulator

d3 (control)

NO INTERVENTION

Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment.

Interventions

making attempts at labor

Also known as: d2=medium reality birth simulator
d1d2

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The research includes all third-year students who registered for the first time to the Normal Birth and Postpartum Term course in the midwifery department in the 2022-2023 academic year in the Department of Midwifery at the Faculty of Health Sciences.

You may not qualify if:

  • Having any of the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Research and Training Hospital of Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 21, 2023

Study Start

October 10, 2022

Primary Completion

July 20, 2023

Study Completion

December 10, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations