Investigating the effect of visual attention on heart rate variability and respiratory rate variability in normal human during white noise
Design
80 participant will divide into four groups. In all four groups, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space
First group (control): After the first 20 minutes, it will be recorded in the same non-stimulating state.
Second group (white noise): After the first 20 minutes, the participant will receive a white noise sound (at a rate of about 70 dB) through the headphones for 20 minutes.
Third group (attention): After the first 20 minutes, in the same situation without sound, the participant will sit in the ANT test for 20 minutes.
Forth Group (attention + white noise): After the first 20 minutes, the participant sitting on the chair takes an ANT test for 20 minutes, and at the same time he receives hearing white noise through the headphones.
At all stages of the recording of the electrocardiogram and respiratory pattern through the analog to digital converter will be processed through the MATLAB program.
Settings and conduct
Alborz University of Medical Sciences, Laboratory of Physiology, one way blind
Participants/Inclusion and exclusion criteria
Medical Students of Alborz University, aged 18-25 years, have normal vision and hearing participant in the test.
Professional athletes, people with chronic illness, people taking medication or stimulants do not enter the test.
Intervention groups
White noise (to alter attention) and ANT (to attracting attention) will use.
Main outcome variables
Investigating the effects of visual attention on dynamic changes in heart rate and respiration in healthy humans during white noise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043176N1
Registration date:2019-04-08, 1398/01/19
Registration timing:prospective
Last update:2019-04-08, 1398/01/19
Update count:0
Registration date
2019-04-08, 1398/01/19
Registrant information
Name
Roham Mazloom
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3428 7315
Email address
rohammazloom@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Visual Attention on Heart Rate Variability and Respiratory Rate Variability During White Noise in Medical Students of Alborz University
Public title
The Effect of Visual Attention on Heart Rate Variability and Respiratory Rate Variability During White Noise
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-25 years
Medical students
Normal vision and audition
Exclusion criteria:
Chronic disease
Professional athletes
Using of treatment and stimulants
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Test participants are not aware of changes made independent variables.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
North Taleghani Boulevaed, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3146883811
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.ABZUMS.REC.1397.140
Health conditions studied
1
Description of health condition studied
Attention
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Heart rate variability
Timepoint
Measurement of dynamic heart rate changes in the first 20 minutes and the second 20 minutes with the research process in each group.
Method of measurement
Electrocardiogram recording via analog to digital conversion device the BIODAC ER21 model, Trita Healthcare Technology Company, will be analyzed through the MATLAB program.
2
Description
Respiratory rate variability
Timepoint
Measurement of dynamic respiratory rate changes in the first 20 minutes and the second 20 minutes with the research process in each group.
Method of measurement
Respiratory pattern recording via analog to digital conversion device the BIODAC ER21 model, Trita Healthcare Technology Company, will be analyzed through the MATLAB program.
Secondary outcomes
1
Description
Linear indices
Timepoint
First 20 minutes and second 20 minutes
Method of measurement
MATLAB Software
2
Description
Nonlinear indices
Timepoint
First 20 minutes and second 20 minutes
Method of measurement
MATLAB Software
Intervention groups
1
Description
Control group: First, for 20 minutes, the person taking the test is seated in the laboratory without any stimuli. In the second step, it will be recorded in the same non-stimulating state.
Category
Other
2
Description
First intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. Secondly, in the same state of sitting, the participant will receive a white noise sound (at a rate of about 70 dB) through the headphones for 20 minutes.
Category
Other
3
Description
Second intervention group: First, for 20 minutes, the person participating in the test will be seated in a laboratory without any stimuli in the laboratory space. Secondly, in the same situation without sound, the participant will sit in the ANT test for 20 minutes.
Category
Other
4
Description
Third intervention group: First, for 20 minutes, the person participating in the test will be seated without any stimuli in the laboratory space. In the second step, the participant sitting on the chair takes an ANT test for 20 minutes, and at the same time he receives hearing white noise through the headphones.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medicine School of Alborz University of Medical Sciences
Full name of responsible person
Roham Mazloom
Street address
Campus of Alborz University of medical Sciences, West Bouali Street, Moazen Boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3428 7315
Email
pezeshki@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Roham Mazloom
Street address
Deputy Director of Research and Technology, Saffarian Street, 45 meters Golshahr Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3922
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Roham Mazloom
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Campus of Alborz University of Medical Sciences, West Bouali Street, Moazen Boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3428 7315
Email
rohammazloom@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Roham Mazloom
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Campus of Alborz University of Medical Sciences, West Bouali street, Moazen Boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3428 7315
Email
rohammazloom@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Roham Mazloom
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Campus of Alborz University of Medical Sciences, West Bouali Street, Moazen Boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3428 7315
Email
rohammazloom@abzums.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
No - There is not a plan to make this available
Title and more details about the data/document
The total data is potentially unobtrusive after being unidentifiable
When the data will become available and for how long
There will be general accessibility after publication.
To whom data/document is available
The data for this research will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
These data can use for different analyzes of heartbeat or breathing pattern
From where data/document is obtainable
Roham Mazloom, Alborz University of Medical Sciences, Karaj, Iran.
rohammazloom@abzums.ac.ir
What processes are involved for a request to access data/document
After receiving the request, the information will be sent to the requesting person by e-mail