Evaluation of a Model-Based CBRN Training Program (CBRN)

February 19, 2024 updated by: Derya Aslan Huyar, Uludag University

The Effect of Chemical Biological Radiological and Nuclear Training Program Based on Mastery Learning Model on the Learning Outcome of Student Nurses

The aim of the study is to evaluate the effect of the Education Program based on the Mastery Learning Model for Chemical, Biological, Radiological, and Nuclear threats and hazards (MLM-CBRN Education Program) on student nurses' knowledge, attitude, self-efficacy, and skill development in chemical, biological, radiological and nuclear threats and hazards. The complete experimental design type was used in the study.

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 aim of the study is to evaluate the effect of the Education Program based on the Mastery Learning Model for Chemical, Biological, Radiological, and Nuclear threats and hazards (MLM-CBRN Education Program) on student nurses' knowledge, attitude, self-efficacy, and skill development in chemical, biological, radiological and nuclear threats and hazards. The complete experimental design type was used in the study. The study sample comprised 104 4th-year nursing students (52 in the experimental group, 52 in the control group). The MLM-CBRN Education Program was carried out with the students in the experimental group face-to-face as theoretical and practical education once a week for four weeks. As a criterion for starting a new unit, 80% of the participants needed to receive minimum 70 points from the unit follow-up tests in line with the "Learning Objective" determined within the scope of the Mastery Learning Model. The data were collected before and right after the intervention and in the 1st and 3rd months after the intervention using the "Personal Information Form," "Nursing Student CBRN Knowledge Test," "Nursing Student CBRN Attitude Scale," and "Nursing Student CBRN Self-Efficacy Scale." Moreover, only the knowledge scores of the students in the experimental group were collected using the unit follow-up tests, which enabled us to check whether the "Learning Objective" related to the unit taught was achieved. During the skill training, the "START Triage and JumpSTART Triage Skill Check List," Gas Mask Wearing-Removing Skill Check List, and Level C Clothes Wearing-Removing Skill Check List were scored for each student in the experimental group after observing the students twice.

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.
104

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 Locations

  • Turkey
    • Nilüfer
      • Bursa, Nilüfer, Turkey, 16285
        • Bursa Uludağ Üniversitesi

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 to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a senior nursing undergraduate student
  • Not having received CBRN training

Exclusion Criteria:

  • Be a full-time worker in a healthcare institution
  • Having taken courses on disaster and CBRN

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: None (Open Label)

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.
No Intervention: Control
No intervention
Experimental: Experimental

The Effect of the Education Based on the Mastery Learning Model on the Practical Skills of Student Nurses in Chemical, Biological, Radiological, and Nuclear Hazards.

The MLM-CBRN Education Program was carried out with the students in the experimental group face-to-face as theoretical and practical education once a week for four weeks.
Behavioral: Mastery Learning Model for Chemical, Biological, Radiological, and Nuclear threats and hazards (MLM-CBRN Education Program) on student nurses
The MLM-CBRN Education Program was carried out with the students in the experimental group face-to-face as theoretical and practical education once a week for four weeks. . The data were collected before and right after the intervention and in the 1st and 3rd months after the intervention using the "Personal Information Form," "Nursing Student CBRN Knowledge Test," "Nursing Student CBRN Attitude Scale," and "Nursing Student CBRN Self-Efficacy Scale." Moreover, only the knowledge scores of the students in the experimental group were collected using the unit follow-up tests, which enabled us to check whether the "Learning Objective" related to the unit taught was achieved. During the skill training, the "START Triage and JumpSTART Triage Skill Check List," Gas Mask Wearing-Removing Skill Check List, and Level C Clothes Wearing-Removing Skill Check List were scored for each student in the experimental group after observing the students twice.

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
Individual Information Form
Time Frame: up to 24 weeks
It consists of items questioning the students' demographic data, their school success, and whether they have received a CBRN education or not.
up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nursing Student CBRN Knowledge Test
Time Frame: up to 24 weeks
Knowledge Test used to determine the knowledge level of nursing students about CBRN consists of 31 items. The answer options of true and false statements. The score that can be obtained from the test varies between 0-31. The results get improve as the points are received.KR-20 was calculated as 0.82
up to 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nursing Student CBRN Attitude Scale
Time Frame: up to 24 weeks
To determine their attitudes about kbrn used it.Attitude Scale. The scale consists of 3 sub-factors. Individual attitude (factor 1), professional attitude (factor 2), and social attitude (factor 3). Scores related to the scale score and sub-dimensions are obtained by adding the scores given to the items and dividing them by the number of items. It is a Likert-type scale and is graded between "5" completely agree and "1" strongly disagree. The Cronbach Alpha is 0.92. The score that can be obtained from the test varies between 1-5. The results get improve as the points are received.
up to 24 weeks
Nursing Student CBRN Self-Efficacy Scale
Time Frame: up to 24 weeks
To determine their self-efficacy about kbrn used it. The Self-Efficacy Scale score is obtained by adding the scores given to the items and dividing them by the number of items. The CBRN attitude scale was grouped under a single factor structure. The scale consists of 9 items. Scores from the scale range from 1 to 5. It is a Likert-type scale. The Cronbach Alpha is 0.90. The score that can be obtained from the test varies between 1-5. The results get improve as the points are received.
up to 24 weeks

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.
Uludag University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Melek Nihal Esin, mnesin@istanbul.edu.tr

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.
January 1, 2020

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.
February 20, 2020

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.
March 12, 2020

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).
December 16, 2021

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.
June 5, 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.
June 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.
February 20, 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.
February 19, 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.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 982d71uk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

if requested; training plan, data collection forms used, presentation content used, checklists used, unit follow-up tests used, and case examples used can be shared.

IPD Sharing Time Frame

1-12 months

IPD Sharing Access Criteria

have ethics committee approval, Researchers who want to do meta-analysis or systematic review

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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