Preliminary Exploration of Applying Multi-person Simulation Training to Improve Nurse-led Burn and Scald Nursing Care

August 28, 2024 updated by: Ying-Li Lee, Chimei Medical Center
The purpose of this study was to compare the learning performance of trainees before and after learning burns and scald nursing care by applying the burns and scald virtual reality (VR) training module multi-person interactive training in different places and the traditional training model with a high-fidelity patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The clinical instructors, standard practice nurses, training content, and assessment process were the same for the experimental and control groups, except for the training methods of the interventions. A pre-recorded instructional video on burn care was provided to each participant one week prior to the experiment for self-study. The experiment procedure includes research description, pre-test and pre-test questionnaire (about 10 minutes), VR hands-on teaching or environment familiarization phase (about 10 minutes), multi-person simulation training (about 15 minutes) and post-test debrief (about 5 minutes), post-test and questionnaire (about 10 minutes). After completing all experiments, the collected data will be analyzed by the researcher using SPSS version 22.0 for descriptive, t-test, and other statistical analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. people who are above 20 years old, with a nurse practitioner certificate and an ACLS or AHA certificate within the validity period.
  2. people who are interested in learning the role of a team leader in burn and scald care.
  3. people who have never used an interactive virtual reality (VR) environment device.

Exclusion Criteria:

  1. people who are prone to vertigo or poor balance and are prone to motion sickness.
  2. people with a history of epilepsy.
  3. eye surgery or injury within the past 6 months.
  4. people with facial wounds that prevent them from wearing VR glasses.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Virtual reality
Other: Multi-person virtual reality simulation scenario training
Using multi-person virtual reality simulation scenario training to evaluate the learning effectiveness of nursing care for emergency burn and scald patients.
Active Comparator: Control group
High Fidelity Simulation Training
Other: Multi-person high-fidelity simulation scenario training
Using multi-person high-fidelity simulation scenario training to evaluate the learning effectiveness of nursing care for emergency burn and scald patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in knowledge of burn and scald nursing care scale
Time Frame: Pre- and post-instructional design (immediately before conducting and after completing simulation scenario training)
There were 10 items to evaluate the participants' knowledge of the burn and scald nursing care scale. Each item had four response options. The total score ranged from 0 to 10 and a higher score indicates a higher level of knowledge of burn and scalds nursing care.
Pre- and post-instructional design (immediately before conducting and after completing simulation scenario training)
Change in motivation and attitude toward learning and personal self-efficacy scale
Time Frame: Pre- and post-instructional design (before conducting and immediately after completing simulation scenario training)
The motivation and attitude toward learning and personal self-efficacy scale included 21 items. Each item was scored on a five-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranged from 21 to 105 and a higher score indicated a positive motivation and attitude toward learning and a higher level of personal self-efficacy in burn and scald nursing care.
Pre- and post-instructional design (before conducting and immediately after completing simulation scenario training)
Self-reported measure of satisfaction of learning
Time Frame: Post-instruction (immediately after completing simulation scenario training)
The satisfaction of learning scale included 9 items. Each item was scored on a five-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranged from 9 to 45 and a higher score indicated a higher level of satisfaction with the learning intervention in burns and scald nursing care.
Post-instruction (immediately after completing simulation scenario training)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chimei Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11105-012

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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