TITLE OF THE RESEARCH PROPOSAL:
“Assessment
and correlation of adverse drug reactions following COVID vaccination with
blood group and dietary style -A pilot study.†HYPOTHESIS/
RESEARCH QUESTION: What are the percentages of different adverse events
experienced by the individuals? Whether AEFI are related to blood groups and
dietary styles of an individual? OBJECTIVES OF THE STUDY: To assess different
types of adverse drug reactions following COVID vaccination and to correlate
with blood groups and dietary style. METHODOLOGY Study design: Questionnaire based
pilot study Materials and methods: This is an online questionnaire
(English version) based cross-sectional study. The validated questionnaire is
prepared using Google forms. This questionnaire will be sent by mail/WhatsApp
to all the students and Staffs of Yenepoya Medical College Hospital, Mangalore.
The responses along with the demographic
data of the participants will be collected, analyzed and interpreted. Ethical clearance will be obtained from the Institutional Ethical
Committee before starting the study. Informed consent will be obtained (in
google form) from the participants
after describing the
purpose of the study and the assurance to maintain the anonymity and
confidentiality This is an online questionnaire (English
version) based cross-sectional study. a)
Study setting: Yenepoya Medical College, Yenepoya deemed to be University, Mangalore,
Dakshina Kannada. b)
Study Population: Health care professionals of various colleges
of Yenepoya (Deemed to be University), Mangalore. c) Study
period: This study shall be
conducted from 20th April 2021 to 20th July 2021 (3months) Source of data/sampling method:
|
Variables
|
Method
of collection
|
Source
|
|
Age, Gender, Blood group & dietary style
|
Questionnaire
form
|
Google
survey
|
|
Questions
of adverse events, time duration etc
|
Questionnaire
form
|
Google
survey
|
Sample size: Due to lack of literature evidence to
calculate sample size, I would like to do time bond study. This will establish
new evidence for future studies. a) Sampling
technique: Time bound sampling method will be followed in this study to collect
the data. The google link of questionnaire form on adverse events following
COVID vaccine will be shared to students and health professionals via WhatsApp
or email and requested them to give feedback and circulate the link to their
friends/batch mates. Their friends/batch mates will be requested to circulate
the google link to their contacts. The procedure will be followed till we
achieve required sample size. b) Sample
size: 100 (time bound) c) Randomization
(if any): Not applicable d) Details
of clinical examination (if any) NA e) Details
of study like questionnaire (if any)- questionnaire attached f) Validation
of study tool (if applicable) – Validated by two professor g) Details
of investigations (if any) NA Inclusion criteria: Medical/dental/Allied
health undergraduates & postgraduate student and health care professionals of
Various colleges affiliated to Yenepoya (Deemed to be University), Mangalore who
are vaccinated and willing to give their consent for this study will be
included. Details of data tabulation and statistical analysis to be employed:
At the end of the study, Statistical analysis will be done using Simple descriptive statistics with appropriate
method to describe the data. Regression analysis technique is used to assess
the adverse drug reactions after Covid-19 vaccination and correlate with blood
group and dietary factors.
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