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CTRI Number  CTRI/2025/01/079090 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluating and Assessing the Students Knowledge, Attitude and Practices Regarding Urinary Tract Infections using a Validated Questionnaire 
Scientific Title of Study   Development and Validation of a Questionnaire to Assess Knowledge, Attitudes, and Practices Towards Urinary Tract Infections (UTIs) Among Medical and Non-Medical Students of a University in Coastal Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghana Hegde 
Designation  MSc Medical Laboratory Technology (Microbiology and Immunology) Student 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7022046727  
Fax    
Email  meghana1.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asha Patil 
Designation  Associate Professor - PhD, MSc MLT 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9900405740  
Fax    
Email  asha.patil@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Asha Patil 
Designation  Associate Professor - PhD, MSc MLT 
Affiliation  Manipal College of Health Professions (MCHP), MAHE 
Address  Department of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi


KARNATAKA
576104
India 
Phone  9900405740  
Fax    
Email  asha.patil@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asha Patil   Manipal Academy of Higher Education, Karnataka  Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA 
9900405740

asha.patil@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Students who are above the age of 18 to 50 years and are willing to participate in the Questionnaire 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  University students belonging to different colleges/institutions (Medical and Non-Medical) under Manipal Academy of Higher Education, Manipal from various departments (Nursing, MBBS, Pharmacology, Allied Health, Public Health Science, Technology, Architecture, Media, Commerce etc)
Students above the age of 18 years will be taken for the study
Students who give consent to do the questionnaire  
 
ExclusionCriteria 
Details  Students not willing to participate in the questionnaire 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop and validate a questionnaire to assess the knowledge, attitude, and practice scores regarding Urinary Tract Infections (UTIs) among medical and non-medical students in a university of coastal Karnataka.  8 Weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the level of knowledge, attitudes, & preventive practices on UTI among medical & non-medical students at a university in Coastal Karnataka.  8 Weeks 
To find the association between the study participant’s knowledge, attitude, & total KAP scores concerning UTI.  8 weeks 
 
Target Sample Size   Total Sample Size="386"
Sample Size from India="386" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Participants will be recruited from colleges under MAHE, Manipal. An online questionnaire will be circulated to students during their free time, such as lunch hours or after 5 PM. Participation will be entirely voluntary, with students required to provide informed consent before completing the questionnaire. Data will be collected electronically through the online submission of completed questionnaires. 
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