The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection

April 16, 2024 updated by: Yonca Çiçek Okuyan, Celal Bayar University

The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, Learning Satisfaction, Anxiety and Self-Efficacy in Newborn Heel Blood Collection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The population of the research consisted of 4th grade midwifery students studying in the fall semester of the 2022-2023 academic year (N = 98). 6 students could not continue studying. No sample selection was made and an attempt was made to reach the entire universe. The sample of the research consisted of a total of 92 midwifery students, n=46 in the control group and n=46 in the experimental group. Verbal and written permission was obtained from the students included in the research. Both the experimental and control groups were given theoretical training on heel blood collection on a model using the show-and-tell technique.Then, those in the experimental group were asked to take heel blood on a newborn model in a high-reality simulation environment. The control group was asked to take heel blood on a newborn model in the simulation laboratory. Self-Efficacy-Efficacy scale for both the experimental group and the control group. State and Trait Anxiety Scale was applied as pre-test and post-test. Student Satisfaction and Self-Confidence in Learning Scale was applied only as a posttest. The heel prick skill evaluation form was filled out by a researcher. Pre-test and post-test results, Student tudent Satisfaction and Self-Confidence in Learning scores , and Heel Blood Skill scores were compared between the experimental and control groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Manisa, Turkey, 45140
        • Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery
      • Manisa, Turkey, 45140
        • Yonca çiçek okuyan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 4th 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: group that practices in a high-reality simulation environment
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

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.
No Intervention: control group
They took heel blood on a newborn model in the simulation room as routine training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skill checklist
Time Frame: during the intervention
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
Time Frame: one hour before and one hour after interventions
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
Time Frame: one hour before and one hour after interventions
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
Time Frame: one month after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celal Bayar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yonca çiçek okuyan, PhD, Manisa Celal Bayar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCBU-SBF-YC-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings