Nursing EducationNCT05677477
The Effect of Hybrid Simulation on Evaluating Neonatal Jaundice
A study testing simulation training in people with Nursing Education, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice. Read more about this study
- Who is it for?
- Ages 19 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Education
- What is being tested?
- simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2022to 31 Mar 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 19 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in the course
- Had not taken this course before
- Accepted to participate in the research
Who cannot join
- Have any records of absence
- Taken this course before
- Graduate of health vocational high school
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çankırı Karatekin Üniversitesi
Çankiri, 18200
Aylin Pekyiğit, 05413528050
About this study
Official title: The Effect of Hybrid Simulation on Nursing Students' Ability to Evaluate Neonatal Physiological Jaundice: A Randomized Controlled Trial
This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.
- Conditions
- Nursing Education
- Being tested
- simulation training
- Keywords
- Nursing education, hyperbillirubinemia, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation trainingOther
A mother scenario with a baby with physiological jaundice will be implemented with the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | In the implementation process of the research, knowledge tests will be applied as pre-test and post-test, and training will be given to the mother who has a baby with physiological jaundice. In the study, the scenario of the mother with a baby with jaundice will be implemented only with the intervention group Receives: Other: simulation training |
| Control | No intervention | During the application process of the research, knowledge tests will be applied as pre-test and post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Information Form and First Knowledge Test
Student Information Form (First Knowledge Test-Before Simulation): In this form, which was created by the researcher by scanning the literature, did he choose the student's number, age, gender, graduated high school, nursing department willingly, did he get information about the simulation before, did he get information about neonatal jaundice? ? The questions are included. In the same survey, there is the "Newborn Physiological Jaundice Assessment Test" consisting of 25 questions created by the researchers. In this questionnaire, there are statements regarding the physiological jaundice of the newborn. Students were asked to mark one of the options "Yes", "No" or "I don't know" for these statements. This form was applied to the students as a pre-test. After the pretest, the subject was explained about the physiological jaundice of the newborn.
This form was filled by both the experimental and control groups.
Measured: One week before Simulation (First week)
Jaundice case checklist form
Jaundice case checklist form (During simulation): This checklist was created by the researcher. There are statements for learning objectives set to evaluate neonatal jaundice. These expressions are "did", "did not" and "partially did". The behavior of the student during the simulation was evaluated by the researcher and his peers. After the simulation, the student was asked to evaluate himself on this form and fill out the form.
Measured: During simulation (Second week)
Second Student Knowledge Test
Second Student Knowledge Test (After the Simulation): 2 weeks after the simulation application, the "Newborn Physiological Jaundice Assessment Test" was applied to both the control and experimental groups. In addition to this test, "Student Satisfaction and Self-Confidence Scale in Learning" and "Simulation Design Scale" were applied to the experimental group.
Measured: Two weeks after simulation (Fourth week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Dec 2022
- Primary completion20 Dec 2022
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin PEKYİGİT, Çankırı Karatekin University
- Investigators
- Müjgan Onarıcı, Study chair, Çankırı Karatekin UniversityTuğba Yıldırım, Study chair, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677477
- Sponsor's protocol ID
- CKU
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Choi YJ. Exploring experiences of psychiatric nursing simulations using standardized patients for undergraduate students. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Sep;6(3):91-5. doi: 10.1016/j.anr.2012.07.001. Epub 2012 Jul 20.
PubMed 25030974
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrid Simulation on Nursing Students' Ability to Evaluate Neonatal Physiological Jaundice: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05677477
- Acronym / sponsor ID
- CKU
- Conditions
- Nursing Education
- Keywords
- Nursing education, hyperbillirubinemia, simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | Experimental | Other: simulation trainingIn the implementation process of the research, knowledge tests will be applied as pre-test and post-test, and training will be given to the mother who has a baby with physiological jaundice. In the study, the scenario of the mother with a baby with jaundice will be implemented only with the intervention group |
| Control | No intervention | –During the application process of the research, knowledge tests will be applied as pre-test and post-test. |
Who may qualify
- Ages
- 19 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in the course
- Had not taken this course before
- Accepted to participate in the research
Key exclusion criteria (3 listed)
- Have any records of absence
- Taken this course before
- Graduate of health vocational high school
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 |
|---|---|---|
| simulation trainingA mother scenario with a baby with physiological jaundice will be implemented with the intervention group. | Other | Intervention/Treatment |
Primary outcome
Student Information Form and First Knowledge Test
Time frame: One week before Simulation (First week)
Student Information Form (First Knowledge Test-Before Simulation): In this form, which was created by the researcher by scanning the literature, did he choose the student's number, age, gender, graduated high school, nursing department willingly, did he get information about the simulation before, did he get information about neonatal jaundice? ? The questions are included. In the same survey, there is the "Newborn Physiological Jaundice Assessment Test" consisting of 25 questions created by the researchers. In this questionnaire, there are statements regarding the physiological jaundice of the newborn. Students were asked to mark one of the options "Yes", "No" or "I don't know" for these statements. This form was applied to the students as a pre-test. After the pretest, the subject was explained about the physiological jaundice of the newborn. This form was filled by both the experimental and control groups.
Jaundice case checklist form
Time frame: During simulation (Second week)
Jaundice case checklist form (During simulation): This checklist was created by the researcher. There are statements for learning objectives set to evaluate neonatal jaundice. These expressions are "did", "did not" and "partially did". The behavior of the student during the simulation was evaluated by the researcher and his peers. After the simulation, the student was asked to evaluate himself on this form and fill out the form.
Second Student Knowledge Test
Time frame: Two weeks after simulation (Fourth week)
Second Student Knowledge Test (After the Simulation): 2 weeks after the simulation application, the "Newborn Physiological Jaundice Assessment Test" was applied to both the control and experimental groups. In addition to this test, "Student Satisfaction and Self-Confidence Scale in Learning" and "Simulation Design Scale" were applied to the experimental group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 25030974Choi YJ. Exploring experiences of psychiatric nursing simulations using standardized patients for undergraduate students. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Sep;6(3):91-5. doi: 10.1016/j.anr.2012.07.001. Epub 2012 Jul 20.
- Individual participant dataSharing planned: Yes
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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.
Müjgan Onarıcı study chair
Çankırı Karatekin University
Tuğba Yıldırım study chair
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation training in people with Nursing Education, run by Çankırı Karatekin University at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin Pekyiğit (05396506489, aylinpekyigit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Information Form and First Knowledge Test (time frame: One week before Simulation (First week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677477, which also lists 1 linked publication.
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 10 Jan 2023.