PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 06:00:15 GMT)

CTRI Number CTRI/2021/05/033592 [Registered on: 12/05/2021] - Trial Registered Prospectively Last Modified On 12/05/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Exploratory Survey study Study Design Other Public Title of Study Perception of public about COVID-19 Vaccination Scientific Title of Perception of public about COVID-19 Vaccination: An Exploratory Survey Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Shalini G Nayak Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation College of Nursing Address Room No. 403 Department of Medical Surgical Nursing, Manipal College of Nursing Manipal Academy of Higher Education, Manipal 1-31-E9, Saraswathichnadra, Baidarabettu; Parkala Post Dist Udupi KARNATAKA 576107 Phone 06176432126 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Mr Anilraj A Query) Designation Lecturer Affiliation Manipal College of Nursing Address Room No. 403, Department of Medical Surgical Nursing Manipal College of Nursing Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Shalini Nayak Designation Assistant Professor Affiliation Manipal College of Nursing Address Room No. 403, Department of medical Surgical Nursing. Manipal College of Nursing Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India

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Phone 09481375675 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Self funded-Manipal COllege of Nursing, Manipal Academy of Higher Education, Manipal Primary Sponsor Primary Sponsor Details Name Shalini G Nayak Address Assistant Professor Medical Surgical Nursing Manipal College of Nursing, MAHE Manipal Type of Sponsor Other [Self] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Shalini G Nayak Manipal College of Online study and the 9481375675 Nursing data will be collected through Google forms shalini.mcon@manipal. across India-Hence edu room number may not be applicable Not Applicable N/A Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Kasturba Medical Approved 27/04/2021 No College and Kasturba Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers General Public Intervention / Type Name Details Comparator Agent Comparator Agent Not interventional study No Intervention in this study Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details All above 18 years of age and willing to participate, able to read English and residing in India will be included. Exclusion Criteria Exclusion Criteria Details Nil Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable

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Primary Outcome Outcome Timepoints Perception of public towards COVID-19 only at base line vaccination Secondary Outcome Outcome Timepoints Nil Nil Target Sample Size Total Sample Size=1094 Sample Size from India=1094 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 25/05/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=5 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL

The present study aim to explore the public perception on COVID-19 vaccination, their worries thought process and their willingness to contain the spread of COVID-19 infection from the country by taking vaccination. In this study data on Perception of public towards COVID-19 Vaccination will be collected from anyone who are willing to give consent to take part in the study and of above 18 years by using Perception scale of public on COVID-19 Brief Summary vaccination. The data will be collected through online mode by administering google form. The participants need to visit the site or the google form only once and will take 10 to 15 minutes. The links of google forms will be shared to the participants through WhatsApp groups. Perception of public towards COVID-19 Vaccination is the prominent outcome measure at the end of the study. The data will be collected among 1094 subjects. There are no

potential risks associated with the study. The study findings will give an overview of public’s perception on COVID-19 vaccination, their worries thought process and their willingness to contain the spread of COVID-19 infection from the country by taking vaccination. These findings may further help address the issues related to vaccination hesitancy if any.

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