The effect of corona personal protective equipment (PPE) on physiological indicators and Fatigue of nursing Intern students after cardiopulmonary resuscitation(CPCR)
Determining the effect of using corona personal protective equipment on physiological indicators and fatigue index of nursing students after cardiopulmonary resuscitation
Design
A clinical trial with a control group, double-blind, randomized, was conducted on 40 nursing intern students, and Randomizer 2016.6.0.56 software was used for randomization.
Settings and conduct
The double-blind study will be done only with the information of the statistical consultant. Intervention people wearing personal protective equipment and control people will perform 12 minutes of resuscitation in the clinical skills center of the nursing school.
Participants/Inclusion and exclusion criteria
Entry requirements :
1. Age 21 to 30 years.
2. No history of respiratory diseases and heart disorders.
3. Body mass index 18 to 30.
4. The resting heart rate is more than 50 or less than 120 beats per minute.
5. At rest, the oxygen saturation should be more than 95%.
6. Breathing rate at rest is more than 10 or less than 20 beats per minute.
7. At the time of conducting the study, they should not be infected with Covid-19 or during the recovery period.
8. Not participating in regular and professional sports activities.
Exit conditions:
1- Withdrawal from further study.
2- Inability to continue working until the end
Intervention groups
In the intervention group, 20 nursing intern students in groups of two wearing personal protective equipment and 20 people in the control group without wearing this equipment perform cardiopulmonary resuscitation for 12 minutes. Immediately after that, the physiological indicators and fatigue index of both groups are recorded.
Main outcome variables
Physiological indicators included heart rate, systolic blood pressure, diastolic blood pressure, arterial blood oxygen, oral temperature and Cr10 Borg fatigue index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220131053897N1
Registration date:2022-08-29, 1401/06/07
Registration timing:prospective
Last update:2022-08-29, 1401/06/07
Update count:0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Sahar Tavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 9605
Email address
s.tavan@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of corona personal protective equipment (PPE) on physiological indicators and Fatigue of nursing Intern students after cardiopulmonary resuscitation(CPCR)
Public title
The effect of personal protective equipment on physiological indicators and fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No history of respiratory diseases and heart disorders
Body mass index 18 to 30
Not participating in regular and professional sports activities
Passing the theoretical and practical unit of cardiopulmonary resuscitation in accordance with the educational curriculum of the field of nursing
Resting heart rate greater than 50 beats per minute or less than 120 beats per minute
At rest, oxygen saturation is more than 95%
Resting breathing rate should be more than 10 or less than 20 beats per minute
Do not have Covid 19 disease or have no symptoms at the time of the study
Do not recover from Covid 19
Absence of pregnancy or menstruation in women at the time of the study
Age 21 to 30 years
Exclusion criteria:
Students who did not pass the 7th nursing semester.
Lack of access to participant prior to randomization
Age
From 21 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of nursing students in the 8th semester will be done by census method. The list of students was prepared from the nursing faculty education unit, according to the conditions of entry into the study and based on the announcement of students' readiness to participate in the study, which was made after the call. Each student was assigned a code that These numbers were randomly selected using Excel software and random data generation, and by entering these codes in the random allocation software, they will be assigned to the intervention (20 people) and control (20 people) groups by the statistical consultant.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, due to the nature of the study, it is not possible to blind the participants, but the data collector and data analyst will be blinded and will not know how to allocate people to two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofJahrom University of Medical Sciences
Street address
Pardis site- Jahrom University of Medical Sciences -- after the Nursing Faculty-- Ostad Motahari St-Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.JUMS.REC.1400.117
Health conditions studied
1
Description of health condition studied
Comparison of physiological indices and students' fatigue index after cardiopulmonary resuscitation with and without personal protective equipment.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue score in Borg cr10 questionnaire
Timepoint
At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups.
Method of measurement
Pressure Borg CR10 Perception Scale Questionnaire
2
Description
Blood pressure score in mm Hg
Timepoint
At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups.
Method of measurement
Tensval digital blood pressure checker comfort model
3
Description
Arterial blood oxygen saturation percentage
Timepoint
At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups.
Method of measurement
New model blood oxygen check machine (onix Vantage)
4
Description
The number of heartbeats per minute
Timepoint
At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups.
Method of measurement
Tensval digital blood pressure checker comfort model
5
Description
Degree of oral fever
Timepoint
At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups.
Method of measurement
Imperial digital thermometer model 301
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. In the beginning, physiological indicators, including systolic and diaphragmatic blood pressure, heart rate, arterial blood saturation, and Borg's fatigue score are expressed by the group members. He performs basic cardiopulmonary resuscitation for 12 minutes, changing the position of two people every 2 minutes. After the recovery, the physiological indicators and the specified number are measured and recorded by the researchers.
Category
Diagnosis
2
Description
Control group: "Control group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. At first, physiological indicators including systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation and oral temperature are taken by the researcher, and the Borg fatigue score is expressed by the group members. They perform cardiopulmonary resuscitation exactly like the intervention group. Immediately after recovery, the physiological indicators and the fatigue index score are measured and recorded again by the researcher.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom University of Medical Science
Full name of responsible person
SaharTavan
Street address
Pardis WebsiteJahrom University of Medical Sciences,after the School of Nursing,Jahrom, Ostad Motahhari St.Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0405
Email
Centlib@jums.ac.ir
Web page address
https://www.jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Kavus solhju
Street address
Pardis site- Jahrom University of Medical Sciences -- after the Nursing Faculty-- Ostad Motahari St-Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
solhju@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
SaharTavan
Position
Internal Masters Student in Nursing Surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alamdar Alley 11,AlamdarKarbalaSt,Fatemieh Town
City
Jahrom
Province
Fars
Postal code
7411475997
Phone
+98 71 5433 9605
Email
S.Tavan@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
SaharTavan
Position
Internal Masters Student in Nursing Surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alamdar Alley 11,AlamdarKarbalaSt,Fatemieh Town
City
Jahrom
Province
Fars
Postal code
741147
Phone
009854339605
Email
S.Tavan@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
SaharTavan
Position
Internal Masters Student in Nursing Surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alamdar Alley 11,AlamdarKarbalaSt,Fatemieh Town
City
Jahrom
Province
Fars
Postal code
7414715997
Phone
+98 71 5433 9605
Email
S.Tavan@jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the individual data of the participants in the intervention groups and the control group, including demographic, biometric, and anthropometric information, after making the individuals unidentifiable by the researcher, can be published in the form of a thesis, printed article, and full and detailed information by accessing the researcher's email can be received.
When the data will become available and for how long
The access period starts 3 months after the results are published in the form of theses and articles.
To whom data/document is available
The data of this study will be available for researchers working in academic and scientific institutions and people working in the field of nursing.
Under which criteria data/document could be used
Applicants use this data after coordination with the researcher and for the purpose of use in the fields of medicine, nursing, sports physiology and with the consent for any analysis on the data required by the applicant.
From where data/document is obtainable
In order to receive the desired documents and data, the applicant can refer to the website of Jahrom University of Medical Sciences at the address /www.jums.ac.ir and enter the title of the thesis and the name of the researcher or via the e-mail of the researcher academy at the address S.Tavan@jums. ac.ir can access the information by contacting the researcher.
What processes are involved for a request to access data/document
The applicant can access the researcher's email three months after the publication of the article by visiting the website of Jahrom University of Medical Sciences and searching for the name of the researcher and the article, or send an email directly to the researcher's email address that is registered on the article, and if the researcher approves, it is complete. The information will be made available to him after making it unidentifiable.