Infant Simulator Training to Measure Pediatric Vital Signs (PedVit)

March 17, 2025 updated by: Hatice Uzşen, Ondokuz Mayıs University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • 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
      • Samsun, Turkey, 55100
        • Black Sea Zone

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
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.
Other: simulation training
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.
Active Comparator: Control
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.
Other: Classical training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
It was assessed just before training as baseline. When all training was completed, ıt was assessed after 1 week again.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: When simulation based training was completed, ıt was assessed after 1 week.
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
When simulation based training was completed, ıt was assessed after 1 week.

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Hatice Uzsen, Phd, Ondokuz Mayıs 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)

March 15, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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