Vital SignsPedVitNCT06780761
Infant Simulator Training to Measure Pediatric Vital Signs
A study testing simulation training and Classical training in people with Vital Signs and Simulation Training, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Providing training to nursing students in the field of pediatric care requires having the competencies to care for the pediatric population. However, as the margin of error in pediatric care is quite narrow, nursing students need to undertake a comprehensive laboratory practice before implementing their care skills… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vital Signs, Simulation Training
- What is being tested?
- simulation training and Classical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 30 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having taken the Pediatric Nursing course
- Voluntarily participating in the study
- Criteria for exclusion from the study were as follows:
- Failure to complete the research process
- Filling out the necessary forms incompletely
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Providing training to nursing students in the field of pediatric care requires having the competencies to care for the pediatric population. However, as the margin of error in pediatric care is quite narrow, nursing students need to undertake a comprehensive laboratory practice before implementing their care skills unsupervised in the pediatric ward. Nursing students can develop their professional skills by gaining the necessary confidence and skills with simulation methods.
Read the detailed description
Simulation makes possible for students to feel a pulse, observe chest movements, hear respiration sounds, measure blood pressure, and evaluate results, thus allowing students to practice with concrete examples of various conditions. Hence simulation-based training, one of the important learning techniques, is assumed to help nursing students overcome the difficulties they will experience in measuring the children's vital signs
- Conditions
- Vital Signs, Simulation Training
- Being tested
- simulation training, Classical training
- Keywords
- vital sign, pediatric, nursing, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation trainingOther
The author further demonstrated taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111 to the students deployed in the intervention group. Furthermore the students were allowed to work individually on the infant simulator, their questions were answered and feedback was given to them. Students were also offered free time to work on the infant simulator. One week after the training, before proceeding with the clinical practice, the students were individually assessed on measuring the vital signs by 2 different observers and were administered the post-tests.
Classical trainingOther
Before proceeding with the clinical practice, the students deployed in the control group were trained on how to measure the five vital signs, which tools to use and why, and normal and abnormal vital sign values by demonstration and explaining on a pediatric nursing manikin. Then, volunteering students were given the opportunity to develop their vital sign measurement skills on a pediatric nursing manikin and feedback was provided to them. One week after the training, all students were individually assessed on measuring the vital signs by 2 different independent observers on the simulator neonatal used in the intervention group and they were administered the post-tests.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Students were trained about taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure, and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111. Receives: Other: simulation training |
| Control | Active comparator | Students were trained on how to measure the five vital signs, which tools to use and why, and normal and abnormal vital sign values by demonstration and explanation on a pediatric nursing manikin. Receives: Other: Classical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs Scale (V-Scale)
The scale, originally developed by Mok et al. in 2015, was further adapted to Turkish by Ertuğ (2018). The 5-point Likert-type scale consists of 16 items and 5 factors. The sub-scales are workload, technology, communication, knowledge and key indicators. The total score varies between 16 and 80. A low score indicates that nurses have a low attitude towards vital signs monitoring while a higher score indicates a positive attitude towards vital signs monitoring. T
Measured: It was assessed just before training as baseline. When all training was completed, ıt was assessed after 1 week again.
Secondary outcomes (1)
Student Satisfaction and Self-Confidence in Learning Scale
The scale originally published by the National Nursing Association was adapted to Turkish by Karaçay and Kara in 2017. The scale, widely used to measure students' attitudes and beliefs about simulation, consists of 13 items and 2 sub-scales
Measured: When simulation based training was completed, ıt was assessed after 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Mar 2023
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The author further demonstrated taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111 to the students deployed in the intervention group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
- Investigators
- Hatice Uzşen, Phd, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780761
- Sponsor's protocol ID
- 2022-577
- Acronym
- PedVit
- Status last verified
- Mar 2025
- First submitted
- 6 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Simulator Training to Measure Pediatric Vital Signs
- ClinicalTrials.gov ID
- NCT06780761
- Acronym / sponsor ID
- PedVit / 2022-577
- Conditions
- Vital Signs, Simulation Training
- Keywords
- vital sign, pediatric, nursing, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Jan 2025 (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.
Providing training to nursing students in the field of pediatric care requires having the competencies to care for the pediatric population. However, as the margin of error in pediatric care is quite narrow, nursing students need to undertake a comprehensive laboratory practice before implementing their care skills unsupervised in the pediatric ward. Nursing students can develop their professional skills by gaining the necessary confidence and skills with simulation methods.
Detailed description
Simulation makes possible for students to feel a pulse, observe chest movements, hear respiration sounds, measure blood pressure, and evaluate results, thus allowing students to practice with concrete examples of various conditions. Hence simulation-based training, one of the important learning techniques, is assumed to help nursing students overcome the difficulties they will experience in measuring the children's vital signs
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The author further demonstrated taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111 to the students deployed in the intervention group
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: simulation trainingStudents were trained about taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure, and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111. |
| Control | Active comparator | Other: Classical trainingStudents were trained on how to measure the five vital signs, which tools to use and why, and normal and abnormal vital sign values by demonstration and explanation on a pediatric nursing manikin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Having taken the Pediatric Nursing course
- Voluntarily participating in the study
- Failure to complete the research process
- Filling out the necessary forms incompletely
Key exclusion criteria (0 listed)
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 trainingThe author further demonstrated taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111 to the students deployed in the intervention group. Furthermore the students were allowed to work individually on the infant simulator, their questions were answered and feedback was given to them. Students were also offered free time to work on the infant simulator. One week after the training, before proceeding with the clinical practice, the students were individually assessed on measuring the vital signs by 2 different observers and were administered the post-tests. | Other | intervention |
| Classical trainingBefore proceeding with the clinical practice, the students deployed in the control group were trained on how to measure the five vital signs, which tools to use and why, and normal and abnormal vital sign values by demonstration and explaining on a pediatric nursing manikin. Then, volunteering students were given the opportunity to develop their vital sign measurement skills on a pediatric nursing manikin and feedback was provided to them. One week after the training, all students were individually assessed on measuring the vital signs by 2 different independent observers on the simulator neonatal used in the intervention group and they were administered the post-tests. | Other | Control |
Primary outcome
Vital Signs Scale (V-Scale)
Time frame: It was assessed just before training as baseline. When all training was completed, ıt was assessed after 1 week again.
The scale, originally developed by Mok et al. in 2015, was further adapted to Turkish by Ertuğ (2018). The 5-point Likert-type scale consists of 16 items and 5 factors. The sub-scales are workload, technology, communication, knowledge and key indicators. The total score varies between 16 and 80. A low score indicates that nurses have a low attitude towards vital signs monitoring while a higher score indicates a positive attitude towards vital signs monitoring. T
1 secondary outcome
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: When simulation based training was completed, ıt was assessed after 1 week.
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 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Hatice Uzşen, Phd principal investigator
Ondokuz Mayıs 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 and Classical training in people with Vital Signs and Simulation Training, run by Ondokuz Mayıs 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 5 inclusion and 0 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 Mar 2025. 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?
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?
Vital Signs Scale (V-Scale) (time frame: It was assessed just before training as baseline. When all training was completed, ıt was assessed after 1 week again.). 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 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.