- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06373874
The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection
The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, Learning Satisfaction, Anxiety and Self-Efficacy in Newborn Heel Blood Collection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Manisa, Turkey, 45140
- Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery
-
Manisa, Turkey, 45140
- Yonca çiçek okuyan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
Sponsor
Investigators
- Principal Investigator: Yonca çiçek okuyan, PhD, Manisa Celal Bayar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU-SBF-YC-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Heel blood collection in a newborn simulation model
-
Hospices Civils de LyonBioMérieuxRecruiting
-
Imperial College LondonDexCom, Inc.; Bold insightRecruitingPregnancy Complications | Gestational DiabetesUnited Kingdom
-
University Hospital, AngersTerminatedDevelopment Delay | Cancer Childhood | Predisposition, GeneticFrance, Réunion
-
Institut CurieCompletedVolunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 InfectionFrance
-
Hospital General Universitario Gregorio MarañonFundación para la Investigación Biomédica del Hospital Gregorio MaranonCompletedAtherosclerosis | Acute Coronary SyndromeSpain
-
Hospices Civils de LyonRecruiting
-
University Hospital, MontpellierCompletedSimulation | Quality of Work Life | Burn-outFrance
-
University of PennsylvaniaEli Lilly and CompanyActive, not recruitingHealthyUnited States
-
Direction Centrale du Service de Santé des ArméesNot yet recruitingHypoxia | Hypoxia, Brain | Hypoxia in Healthy Individuals | Hypoxia, Altitude | Altitude Hypoxia | Altitude | Hypoxia Altitude Simulation Test | Hypoxia Brain | Normobaric HypoxiaFrance
-
Centre Hospitalier Metropole SavoieCompletedDiet Habit | Type I Diabetes | Activity, Motor | ControlFrance