NCT05864859

Brief Summary

Proving the empathy level and privacy protection effectiveness of the low-cost, high-reality and interactive education model constitutes the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its impact at the social level in terms of midwifery students in particular and positive birth experience and qualified midwifery care in general. It will also provide data for the comparison of innovative education methods with traditional education methods. Thus, it will help to improve, regulate or build capacity of future initiatives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 9, 2023

Last Update Submit

July 4, 2024

Conditions

Keywords

SimulationEmpathyPrivacy

Outcome Measures

Primary Outcomes (2)

  • Privacy

    Privacy Protection Scale in Obstetrics and Gynecology: The scale has 2 sections: awareness level and application frequency, 2 sub-dimensions: physical-social privacy (items 1-15) and psychological-information privacy (items 16-30) and the total It consists of 30 items. There are no items that need to be reversed in calculating the total scale score. The Cronbach Alpha reliability coefficient of the scale is 0.95 for the level of awareness section, 0.96 for the frequency of application section, 0.90 and 0.92 for the physical-social privacy sub-dimension, and 0.93 and 0.94 for the psychological-information privacy sub-dimension. was found as. The increase in the scores individuals receive from the scale indicates that their privacy awareness levels are high and their frequency of privacy-oriented practices is high.A minimum score of 30 and a maximum score of 150 is obtained from the scale.

    1 years

  • Empathy

    Empathic Tendency Scale (EES): Empathic Tendency A validity and reliability study of the scale was conducted and the reliability coefficient was found to be 0.82. This is what was done In the study, the Cronbach alpha coefficient was determined as 0.75. Individuals express their agreement with the opinion in the relevant article by marking one of the numbers from 1 to 5 next to each item. The marked numbers constitute the scores for that item. The highest total score that can be obtained is 100 and the lowest score is 20. A high total score means that the empathic tendency is high. Some expressions in the empathic tendency scale are written negatively and reversed to prevent people from saying "yes". To avoid the tendency to say yes, the statements in the 3rd, 6th, 7th, 8th, 11th, 12th, 13th, 15th rows are written backwards. The scoring for these items is; It was determined as completely inappropriate (5 points) and completely appropriate (1 point).

    1 years

Study Arms (3)

Normal birth group

EXPERIMENTAL

It consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario where there was no complication during labor.

Other: Simulation

Breech birth group

EXPERIMENTAL

It consisted of preliminary information (10 minutes), practice (10 minutes) and analysis (20 minutes) sessions with groups of 2 people (1 midwife, 1 pregnant) accompanied by a scenario that experienced complications during labor.

Other: Simulation

Control group

NO INTERVENTION

She continued her education in accordance with the (1+32) hour curriculum within the scope of the midwifery undergraduate program Integrated Practice I and EBE402 Integrated Practice II courses.

Interventions

In the simulation session, while 2 participants (1 midwife, 1 pregnant) performed the roles in accordance with the clinical scenario, the performance was recorded in the control room. A Wearable Pregnancy Simulator was worn by the student performing the pregnant role. During the simulation, the participants were able to interact with the facilitators when they had questions. The application time did not exceed 10 minutes.

Breech birth groupNormal birth group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a final year midwifery student,
  • Not being married
  • To be nulliparous
  • Volunteering to participate in research

You may not qualify if:

  • Having the ability to read, listen, write, speak and understand Turkish,
  • Repeating the course,
  • Unwilling to withdraw from research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

  • Karakoc H, Ozkan H. The effect of wearable simulated birth model on students' empathy and privacy protection levels: a randomised controlled trial. BMC Med Educ. 2026 Feb 5. doi: 10.1186/s12909-025-08441-8. Online ahead of print.

Study Officials

  • Hediye KARAKOÇ

    KTO Karatay University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

January 1, 2023

Primary Completion

February 1, 2024

Study Completion

July 1, 2024

Last Updated

July 8, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations