NCT06373874

Brief Summary

The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 8, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

Skills traininghigh reality simulation environmentskills laboratorymidwifery training.

Outcome Measures

Primary Outcomes (4)

  • Skill checklist

    The heel prick skill (20 tasks/step) is based on checklists for evaluating student management, recommendations of the Ministry of Health and WHO, and training materials and guides prepared by the Ministry of Health. Each task/step was evaluated as "outstanding" if performed completely and correctly, and as "needs improvement" if performed incompletely and incorrectly. Needs improvement is rated as 1 point, sufficient as 2 points. As a result of the skill checklist, the lowest score is 1 and the highest score is 40

    during the intervention

  • State and Trait Anxiety Scales

    It is used to determine state and trait anxiety levels in individuals. State-Trait Anxiety Scale consists of a total of 40 items, 20 items each. The State Anxiety Scale requires the individual to describe how he or she feels at a particular moment and under certain circumstances. The total score of the scale varies between 20-80. A high score from the scale indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    one hour before and one hour after interventions

  • Self-Efficacy Scale

    The scale was developed to determine behavior and behavioral changes. The scale consisting of 23 items is a 5-point Likert type self-evaluation scale. It includes the options 1-"does not describe me at all", 2-"describes me a little", 3-"undecided", 4-"describes me well", 5-"describes me very well" and the score given for each item is taken as basis. Scores between 23 and 115 are obtained from the scale. A minimum of 23 and a maximum of 115 points can be obtained from the entire scale. A high total score from the scale indicates that the individual's perception of SEM is at a good level.

    one hour before and one hour after interventions

  • Student Satisfaction and Self-Confidence in Learning Questionnaire

    It evaluates student satisfaction and self-confidence in learning. The total number of items is 12. The scale is a 5-point Likert type and consists of the subscales "Satisfaction with Current Learning" and "Self-Confidence in Learning". The satisfaction with current learning subscale consists of 5 items, the self-confidence in learning subscale consists of 7 items, and there are no negative items. The sum of the subdimensions of the scale does not give the total score. Scale scores; It is obtained by dividing the sum of the sub-dimensions by the number of items. As the total score from the scale increases, student satisfaction and self-confidence in learning also increases.

    one month after intervention

Study Arms (2)

Experimental: group that practices in a high-reality simulation environment

EXPERIMENTAL

The researcher showed the student how to take heel blood on the model. The researcher introduced both high-reality simulation environment. As a pre-test, the student was asked to fill out the Introductory Information Form, Self-Efficacy-Efficacy Scale and State and Trait Anxiety Scales surveys. Midwifery students in the experimental group were asked to take heel blood on a model in a high-reality simulation environment.Heel blood collection skill evaluation form was filled out by the researcher.As a post-test, the student was asked to fill out the Introductory Information Form, Self-Efficacy Scale and State and Trait Anxiety Scales surveys.

Behavioral: Heel blood collection in a newborn simulation model

control group

NO INTERVENTION

They took heel blood on a newborn model in the simulation room as routine training.

Interventions

The person who will take heel blood in the newborn simulation model can prepare the materials. Firstly, the blood sample can fill in all the information on the filter paper. Knows where the baby's face should be. It can determine the area where a heel blood sample can be taken.It can gently warm the heel area for a few minutes. The area can be cleaned with alcoholic preparation (cotton/swab, etc.). He can squeeze the heel with his thumb and index finger in front. The other 3 fingers can be rubbed at the back. May stroke the heel three times. The heel can be pierced once with a lancet at a suitable location. He can relax his hand. He can wipe away the first drop of blood. It can create a large thick drop of blood to be collected on filter paper. It can make the drop fill the entire ring on the filter paper with one touch. After the procedure is completed, the heel can be pressed.

Experimental: group that practices in a high-reality simulation environment

Eligibility Criteria

Age21 Years - 32 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMidwifery students
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • th grade students (n=49) who took the Maternal and Child Health Practice course of the Midwifery Department and agreed to participate in the study voluntarily were included in the study.

You may not qualify if:

  • Students in younger grades who did not take the Maternal and Child Health Practice course were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery

Manisa, 45140, Turkey (Türkiye)

Location

Yonca çiçek okuyan

Manisa, 45140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yonca çiçek okuyan, PhD

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment experimental study with experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Celal Bayar University, Midwifery Department, Research Assistant Dr.

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 18, 2024

Study Start

April 1, 2023

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations