ClinicalTrials.gg
Status unknownNCT05999409Updated Nov 29, 2023

Normal Birth Management and Use of Simulation

An interventional study of practice on birth simulator in Obstetric, sponsored by Ondokuz Mayıs University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2022, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
Female
01

Study 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.

Read the detailed description

Introductory Information Form (IIF); It was created by the researchers by scanning the literature (11,25-28). This form includes the socio-demographic characteristics of the students, the presence of a health worker in the family, their normal birth practice status and their simulation training (age, graduated high school, monthly income, presence of a health worker in the family, normal birth practice monitoring and performance, simulation training). receiving status etc.) consists of a total of 10 questions.

Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the literature (29-31). In the form, there are 50 items about the steps that the student should do during the normal labor practice. Evaluation of the form is as "he did" and "did not" in relation to the student's implementation of the activities to be observed during the normal labor process steps. In the form, the student was given 2 points for each activity he did, while 0 points were given for the activities he did not do. The lowest score that can be obtained from the form is 0, and the highest score is 100. A high score will indicate high skill, and a low score will indicate low skill.

For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have researched on learning techniques related to the management of normal labor were consulted. The Lawshe technique was used to evaluate the content validity of the items in the form. According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35). No item with a content validity ratio below 0.99 was detected. In order to test the intelligibility of the items, a pilot study was conducted with 10 students from another class who had no knowledge of the content, and the form was given its final form.

Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of "Satisfaction with Current Learning" and "Self-Confidence in Learning". The sub-title of satisfaction with current learning consists of 5 items, the sub-title of self-confidence in learning consists of 7 items and there is no negative item. The cronbach alpha value of the scale for "Satisfaction with Current Learning" is .85, while it is .77 for "Self-Confidence in Learning", it is .89 for the total scale. Scale scores; It is obtained by dividing the sum of the sub-dimensions by the number of items. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase.

Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5 sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All statements in the scale are positive and there is no reverse coded item. Within the scope of the scale, the basic competencies that midwives and nurses should have; care process, patient safety, professional knowledge, communication and reflected behavior concepts are evaluated. An increase in the score obtained from the sub-dimensions in the scale means that the sub-dimension goal has been achieved for the student in the scenario (37).

02

Conditions studied

  • Obstetric
03

In context

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 275 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Having any of the above criteria
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    d1

    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

  • Experimental
    d2

    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

  • No intervention
    d3 (control)

    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

  • Otherpractice on birth simulator

    making attempts at labor

    Also known as: d2=medium reality birth simulator

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What researchers measure

Primary outcomes

  1. providing access to the number

    enough practice by students

    Time frame: through study completion, an average of 9 month

07

Study locations

1 site
  • Health Research and Training Hospital of Tokat Gaziosmanpaşa University
    Tokat Province, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Undecided — Data can be shared if requested from researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05999409
Responsible party
Serap Ozturk Altinayak (assistant professor, Ondokuz Mayıs University) — Principal investigator
First posted
Aug 21, 2023
Start date
Oct 10, 2022
Primary completion
Jul 20, 2023
Completion
Dec 10, 2023 (estimated)
Last update
Nov 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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