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The Effect of Practical Training Program Using Various Feedbacks on Nurse´s Personal Protective Equipment

Status Approved

First Submitted Date

2018/10/31
Registered Date

2019/01/18
Last Updated Date

2019/01/08

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003438
Unique Protocol ID	NHIMC2018-04-031-001
Public/Brief Title	A randomized controlled study to test the effects of education on nurses' wearing of personal protective equipment
Scientific Title	The Effect of Practical Training Program Using Various Feedbacks on Nurse´s Personal Protective Equipment
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	NHIMC2018-04-031-001
Approval Date	2018-06-08
Institutional Review Board Name	National Health Insurance Service Ilsan Hospital Institutional Review Board
Institutional Review Board Address	100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-900-0657
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	yeon jeong hwa
Title	nurse
Telephone	+82-31-900-0061
Affiliation	National Health Insurance Service Ilsan Hospital
Address	Ilsan-ro 100, Ilsan-gu, Goyang-si, Gyeonggi-do,
Contact Person for Public Queries
Name	yeon jeong hwa
Title	nurse
Telephone	+82-31-900-0061
Affiliation	National Health Insurance Service Ilsan Hospital
Address	Ilsan-ro 100, Ilsan-gu, Goyang-si, Gyeonggi-do,
Contact Person for Updating Information
Name	yeon jeong hwa
Title	nurse
Telephone	+82-31-900-0061
Affiliation	National Health Insurance Service Ilsan Hospital
Address	Ilsan-ro 100, Ilsan-gu, Goyang-si, Gyeonggi-do,

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2018-07-04 Actual
Target Number of Participant	60
Primary Completion Date
Study Completion Date
Name of Study	National Health Insurance Service Ilsan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-07-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Health Insurance Service Ilsan Hospital
Organization Type	Medical Institute
Project ID	NHIMC 2018-04-031-00

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	National Health Insurance Service Ilsan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Infection control Personal education should be systematically educated through hands-on experience, and accurate and proficient through effective and immediate feedback methods The effectiveness of the feedback exercises shows that a group of feedback practitioners is more satisfied with the lesson and can improve their self-confidence and interpersonal skills as well as improve their clinical performance (Clynes & Raftery, 2008). If the intensive feedback is given to the nurses through feedback using the smartphone as well as the oral feedback method in the on-the-job training, it can be used effectively as an efficient learning strategy for the nurse. In order to recognize the importance of infectious disease management, infection management education based on field practice similar to actual situation is required and various education programs to be directly applied to the field are required The purpose of this study is to verify the effectiveness of realistic education program using practical training and intensive feedback using real - time clinical room isolation room to improve nurse 's ability to perform personal protective services.

Study Summary Information

Lay Summary

Infection control Personal education should be systematically educated through hands-on experience, and accurate and proficient through effective and immediate feedback methods
The effectiveness of the feedback exercises shows that a group of feedback practitioners is more satisfied with the lesson and can improve their self-confidence and interpersonal skills as well as improve their clinical performance (Clynes & Raftery, 2008). If the intensive feedback is given to the nurses through feedback using the smartphone as well as the oral feedback method in the on-the-job training, it can be used effectively as an efficient learning strategy for the nurse.
In order to recognize the importance of infectious disease management, infection management education based on field practice similar to actual situation is required and various education programs to be directly applied to the field are required

The purpose of this study is to verify the effectiveness of realistic education program using practical training and intensive feedback using real - time clinical room isolation room to improve nurse &#39;s ability to perform personal protective services.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Health Services Research
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others (education)
Intervention Description	After the training, the control group and the experimental group were surveyed about knowledge and attitude about wearing personal protective clothing. The survey took about 10 minutes. The performance of the control group and the experimental group was evaluated in the same manner. First, wear personal protective equipment, apply fluorescent material and remove it. After setting up a dark room environment, check fluorescent pollution using ultraviolet rays. Secondly, the degree of success of the tuberculosis mask is evaluated by performing the adhesion test. The performance evaluation takes about 20 minutes.
Number of Arms	2
Arm 1	Arm Label Experimental group
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description After the training, the control group and the experimental group were surveyed about knowledge and attitude about wearing personal protective clothing. The survey took about 10 minutes. The performance of the control group and the experimental group was evaluated in the same manner. First, wear personal protective equipment, apply fluorescent material and remove it. After setting up a dark room environment, check fluorescent pollution using ultraviolet rays. Secondly, the degree of success of the tuberculosis mask is evaluated by performing the adhesion test. The performance evaluation takes about 20 minutes
Arm 2	Arm Label Contol group
	Target Number of Participant 30
	Arm Type Active comparator
	Arm Description In the control group, the basic education of 'hand hygiene', 'quarantine disease and personal protective equipment' which is the basis of infection control is carried out in the same way. A lecture including video was conducted for 60 minutes as a teaching method.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (Z00-Z99)Factors influencing health status and contact with health services (Z00.6)Examination for normal comparison and control in clinical research programme healthcare personal
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~45Year
	Description (818 beds) in Gyeonggi province. The selection criteria were for nurses who had less than three years of clinical experience who wanted to participate and announce their training schedule
Exclusion Criteria	The exclusion criteria were nurses who had more than 3 years experience
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Knowledge, attitude, performance(Check for contamination)
Timepoint	After practice
Secondary Outcome(s) 1
Outcome	Mask tightness inspection
Timepoint	After practice

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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