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16/02/2022,
Nellore

From
Dr. B. Chandini Reddy,
CRRI
Narayana Medical College,
Nellore.

To,
The Member secretary,
Institutional Ethics Committee,
Narayana medical college,
Chintareddy palem,
Nellore.

THROUGH PROPER CHANNEL

Respected Sir,

Sub: Submission of Research proposal for Ethical committee approval – Regd…

I, Dr. B. Chandini Reddy, completed MBBS and working as an Intern in Narayana Medical
College and Hospital. I would like to participate in a research program in collaboration with the
Department of Physiology, Narayana Medical College and Hospital. I am submitting my
Research proposal to IEC “Evaluation of cognitive and Psychomotor abilities in Covid-19
infected medical students – A cross sectional study”. So kindly consider and do the needful.

Thanking you,

Yours sincerely,

( B. CHANDINI REDDY)

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PROFORMA APPLICATION FOR APPROVAL OF

RESEARCH PROJECT BY INSTITUTIONAL
ETHICAL COMMITTEE, NMC, NELLORE.

SECTION
a. Title of the study
EVALUATION OF COGNITIVE AND PSYCHOMOTOR ABILITIES IN
COVID-19 INFECTED MEDICAL STUDENTS – A CROSS SECTIONAL
STUDY
b. Principal Investigator (Name and designation).

Dr. B. CHANDINI REDDY, CRRI, Narayana Medical College

Dr. B. V. BHARATH KUMAR REDDY, CRRI, Narayana Medical College

c. Co- Investigator (S) (Name and designation).

1. Dr. RAZIYA Associate Professor, Department of Physiology, NMC.

2.Dr. K.N.MARUTHY. Professor, Department of Physiology, NMC.

3. Dr. A. V. SIVA KUMAR, Assistant Professor, Department of Physiology,

NMC.

d. Names of the collaborating departments/ institutions.

No

e. Whether permission has been obtained from the head of the

Collaborating departments/institutions. –
NA

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SECTION B
Summary of the project :
Coronavirus disease (COVID-19) is an infectious disease caused by SARS-CoV-2
virus, which is an airborne infection. The “World Health Organization” had
declared Covid -19 as “pandemic” in 2020 which was spread to all over the
countries. Many people have experienced mild to moderate systemic illness and
recovered without any special treatment. However, some have become seriously ill
and required medical attention. As the medical students are front line warriors who
have been exposed to Covid-19 infection which may have long term unidentified
complications(1). These changes can be attributed to the massive steroid therapy and
mutation of virus. Most of the medical students are experiencing decline in cognition
and psychomotor skills which were not reported. There is paucity in the literature to
provide the association between Covid-19 infection and cognitive impairment.
Therefore, we have aimed to evaluate the Covid-19 infected medical students for their
cognitive functions and psychomotor skills among young medical students in our
institute.
SECTION C
Objectives of the Study:
1. To evaluate cognitive and psychomotor abilities of young medical students.
2. To compare the cognitive and psychomotor skills between infected and non –
infected medical students.
3. To find out association of age, gender, and other demographic variables on
cognitive impairment.
4. To find out frequency of Covid -19 infection and effect of vaccination
cognitive and psychomotor skills.
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SECTION D

Methodology

Materials:-

1. PC -1000 Hz device for Auditory & Visual Reaction Times

Nethra CFF device
2. Audacity software
3. Self designed trail sheet for trail making test
4. Dr Trust weighing machine that calculates muscle mass and body water
5. Dr Trust digital Blood Pressure apparatus
6. Pulse oximeter
7. Buzz wire
8. 100 pins dexterity tool
10. Computer to acquire the data

Method :-
Inclusion Criteria in Test group:-

1. Age group : 18-26 years

2. Gender : Male and female

Apparent healthy volunteers aged between 18-

26 years who had been infected with Covid 19 infection based on RT-PCR result.

Exclusion criteria in Test group :-

1. Age group :- less than 18 & more than 27

2. Gender : Males and Females.

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1.Patients who are suffering with Covid 19 at present.

2.Subjects with neurological defects.
3.Non vaccinated subjects.
4.Those who are not willing to participate in the study
Inclusion Criteria in Control group:-

1. Age group : - 18- 26years.

2. Gender : - Male and Female.

3. Apparent healthy volunteers who have not been infected with Covid 19 and

undergone recently through Master health check up.

Exclusion criteria in control groups:-

1. Age group :- Less than 18 & more than 26

2. History of any communicable and non communicable diseases that cause
neurological comorbidities.

a. Where the proposed study will be undertaken.

Narayana Medical College & Hospital, Nellore.

b. Duration of Project:
Around Six Months.
c. Nature of Subjects:
i. Does the study involve adult patients? No
ii. Does the study involve children No
iii. Does the study involve normal volunteers? Yes
iv. Does the study involve psychiatric patients? No

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v. Does the study involve pregnant women? No

d. If the study involves healthy volunteers:

i. Will they be institute students? Yes
ii. Will they be institute employees? No
iii. Will they be paid? No
iv. If they are to be paid, how much per session? No

e. Is the study a part of a multicentric trial? No

f. If yes, who is the co-ordinator? (Name and designation).

Has the trial been approved by the ethics committees of the other centers?
No

g. If the study involves the use of drugs, please indicated whether,

i. The drug is marketed in India for the indication in which it will be used
in
the study No
ii. The drug is marketed in India, but not for the indication in which it is
Proposed to be used No
iii. The drug is only used for experimental use in humans No
iii. Clearance from the drugs controller of India has been obtained for:
- Use of drug in healthy volunteers No
- Use of drug in patients for a new indication No
- Phase one and two clinical trials
- Experimental use in patients and healthy volunteers No
h. How do you propose to obtain the drugs to be used in the study?
i) Gift from a drug company No
ii) Hospital supplies No
iii) Patient will be asked to purchase No
iv) Other sources (explain) No
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i. Funding (if any) for the project. Please state NA

i) None
ii) Amount
iii) Source
iv) To whom payable

j. Does any agency have a vested interest in the outcome of the project?
No
If yes, Name the agency

k. Will data relating to subjects/controls be stored in a computer? Yes

If yes, can you ensure confidentiality? Yes

l. Will the data analysis be done by?

i) The researcher? Yes
ii) The funding agency? No

m. Will technical/nursing help be required from the staff of the hospital?

Yes
If yes, will it interfere with their duties No
Will you recruit other staff for the duration of the study? No
If yes, give details of:
i. Designation
ii. Qualification
iii. Number
iv. Duration of employment
n. Will informed consent be taken? Yes
If yes:
Will it be written with informed consent?
Yes
Will it be oral consent? Yes

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Will it be taken from the subject themselves? Yes

Will it be taken from the legal guardian? No

If no, give reasons: Subjects chosen for the study are adults. So, a legal
guardian is not required. As the cognitive and psychomotor tests to be conducted
are non-invasive, informed oral consent is to be taken.
TITLE: EVALUATION OF COGNITIVE AND PSYCHOMOTOR ABILITIES IN
COVID-19 INFECTED MEDICAL STUDENTS – A CROSS SECTIONAL STUDY
Design, Methodology and Techniques :-
Study Design:-
It is a cross sectional study that will be carried out in 60 young medical students aged
between 18 – 26 years who have been either infected and non infected with Covid -
19. All participants will be subjected for preliminary evaluation of Covid -19 related
signs and symptoms. A structured questionnaire was developed to update their
information to the investigators. Later, All participants will be evaluated for
Cognitive functions and psychomotor skills.

Requirements:-
1. PC -1000 Hz device for Auditory & Visual Reaction Times
2. Nethra CFF device
3. Audacity software
4. Self designed trail sheet for trail making test
5. Dr Trust weighing machine that calculates muscle mass and body water
6. Dr Trust digital Blood Pressure apparatus
7. Pulse oximeter
8. Buzz wire
9. 100 pins dexterity tool
Methodology:

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Demographic Variables – Age, Gender, Height, Weight, BMI, Vital signs and
Body fat percentage using standard instruments.
Cognitive Variables –
1. Auditory Reaction Time (ART)
2. Visual Reaction Time (VRT)
3. Critical Flicker Fusion Frequency (CFFF)
Psychomotor variables -
1. Buzz wire test
2. 100 pin dexterity test
3. Number countdown test
4. Phonemic memory test
5. Self designed trail sheet for trail making test

1. Critical Flicker Fusion Frequency (CFFF)

The time resolving ability of the eye is determined by measuring the critical fusion
frequency. It is one of the cognitive function tests, which is used to measure the
central nervous system activity and arousal.
● Proper instructions are given to the subject regarding the experiment and
reassure that the test would not do any harm to him.
● Make the subject sit comfortably in a less illuminated room.
● Ask the subject to observe carefully the series of light stimuli at different
frequencies coming from the device.
● Change the frequency of light stimuli on Nethra software until the subject is
unable to perceive the light is flickering.
● Record the last frequency at which, where the subject is reported.
2. Number count down test:
The Number count down test is a neuropsychological test that examines decision
making process.

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● Proper instructions are given to the subject regarding the experiment and
reassure that the test would not do any harm to him/her.
● Make the subject sit comfortably in a less illuminated room.
● Ask the subject to ascend and descend the numbers with a difference of 2.
● The time taken for this protocol indicates the neural circuit decision making
Process(2).
3. Auditory reaction time:
Requirement: PC 1000 Hz Reaction timer.
Procedure:
● Proper instructions are given to the subject regarding the experiment and
reassure that the test would not do any harm to him.
● Make the subject sit comfortably in a less illuminated room.
● Investigator provides the auditory stimulus (sound) by pressing the START
button in the initial component which is out of the view of the subject.
● As soon as the subject hears the sound in the headphone, they are asked to press
the STOP button in their component.
● ART will be recorded in Audacity software in wave format.
4. Visual reaction time:
Requirement: PC1000Hz Reaction timer.
Procedure:
● Proper instructions are given to the subject regarding the experiment and
reassure that the test would not do any harm to him.
● Make the subject sit comfortably in a less illuminated room.
● Investigator provides a visual stimulus (LED) by pressing the START button in
the initial component which is outside the view of the subject.
● As soon as the subject perceives the red light in the instrument, they are asked
to press the STOP button in their component.
● VRT will be recorded in Audacity in wave format(3).
5. 100 Pin Dexterity test:

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This test assesses the number of pins placed in the module. The subjects will be
instructed to place the pins and their score will be counted based on their
number of pins assembled within stipulated time(4).

REFERENCES
1. Hutahayan B. The effect of changes of learning systems on learning outcomes
in COVID-19 pandemic conditions. The Journal of Asian Finance, Economics
and Business. 2021;8(3):695-704.
2. Kumar CK, Kumar AS, Madhurima P, Maruthy KN, Preetham GJ. Assessment
of psychomotor skills using finger pulse guided biofeedback tool in young
medical students: psychomotor skills using heart rate as biofeedback tool.
Annals of Medical Physiology. 2018 Dec 31;2(4):36-9.
3. Kumar AP, Kumar KM, Padmavathi R. Validation of PC 1000 Hz reaction
timer with Biopac® MP 36 for recording simple reaction time. Indian J Physiol
Pharmacol. 2019;63(2):138-44.
4. Srinag L, Maruthy KN, Kareem SK, Kumar AS, Kumar K, Gurja JP. Impact of
overweight on cognition and psychomotor skills among children with
overweight. Obesity Medicine. 2020 Jun 1;18:100191.

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NARAYANA MEDICAL COLLEGE & HOSPITAL

CHINTHAREDDYPALEM, NELLORE.

DEPARTMENT OF PHYSIOLOGY

CONSENT FORM

I am willing to volunteer for the “EVALUATION OF COGNITIVE AND

PSYCHOMOTOR ABILITIES IN COVID-19 INFECTED MEDICAL
STUDENTS – A CROSS SECTIONAL STUDY”, undertaken by
Dr.B.V.Bharath Kumar Reddy and Dr. B. CHANDINI REDDY, CRRI in
collaboration with Department of Physiology. I am fully aware of the procedures,
which I will be undergoing during the study. I volunteer to study.

OP/IP NO. : ______________________

Volunteer Name: __________________ Name of the investigator: ________

Signature : ______________________ Signature: ____________________

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Date : ______________________

Place : _______________________

1.Dr Trust blood pressure monitoring apparatus

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2.PC -1000 Hz device for Auditory & Visual Reaction Times

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3.Nethra CFF device

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4.Dr Trust weighing machine that calculates muscle mass and body water

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5.Buzz wire test

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