StudentsNCT06373874
The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection
A study testing Heel blood collection in a newborn simulation model in people with Students and Educational Problems, run by Manisa Celal Bayar University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 32 years, women only
- Conditions the study is for
- Students, Educational Problems, Anxiety
- What is being tested?
- Heel blood collection in a newborn simulation model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 32 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Students in younger grades who did not take the Maternal and Child Health Practice course were excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery
Manisa, 45140
Yonca çiçek okuyan
Manisa, 45140
About this study
Official title: 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.
Read the 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.
- Conditions
- Students, Educational Problems, Anxiety
- Being tested
- Heel blood collection in a newborn simulation model
- Keywords
- Skills training, high reality simulation environment, skills laboratory, midwifery training.
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel blood collection in a newborn simulation modelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Apr 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment experimental study with experimental and control group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonca Çiçek Okuyan, Manisa Celal Bayar University
- Investigators
- Yonca çiçek okuyan, PhD, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373874
- Sponsor's protocol ID
- MCBU-SBF-YC-04
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, Learning Satisfaction, Anxiety and Self-Efficacy in Newborn Heel Blood Collection
- ClinicalTrials.gov ID
- NCT06373874
- Acronym / sponsor ID
- MCBU-SBF-YC-04
- Conditions
- Students, Educational Problems, Anxiety
- Keywords
- Skills training, high reality simulation environment, skills laboratory, midwifery training.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment experimental study with experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental: group that practices in a high-reality simulation environment | Experimental | Behavioral: Heel blood collection in a newborn simulation modelThe 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. |
| control group | No intervention | –They took heel blood on a newborn model in the simulation room as routine training. |
Who may qualify
- Ages
- 21 to 32 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Students in younger grades who did not take the Maternal and Child Health Practice course were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heel blood collection in a newborn simulation modelThe 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. | Behavioural | Experimental: group that practices in a high-reality simulation environment |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonca çiçek okuyan, PhD principal investigator
Manisa Celal Bayar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heel blood collection in a newborn simulation model in people with Students and Educational Problems, run by Manisa Celal Bayar University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill checklist (time frame: during the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.