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CTRI Number  CTRI/2024/03/063670 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To assess the acceptance and health needs of the “lesbian, gay, bisexual, transgender, queer, asexual, and intersex” (LGBTQAI+)  
Scientific Title of Study   A descriptive study to assess the social acceptance and awareness of health needs of the “lesbian, gay, bisexual, transgender, queer, asexual, and intersex” (LGBTQAI+) population as perceived by the nursing students 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratheek 
Designation  Student 
Affiliation  Manipal academy of higher education 
Address  2nd Year Post basic BSC nursing student class room no 105 Manipal college of nursing MAHE Manipal Udupi Karnataka India-576104

Udupi
KARNATAKA
576104
India 
Phone  9964344579  
Fax    
Email  shettypratheek48@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Daisy josphine lobo 
Designation  associate professor and guide  
Affiliation  Manipal academy of higher education 
Address  Department of medical surgical nursing Manipal college of nursing MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535687697  
Fax    
Email  daisy.j@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Daisy josphine lobo 
Designation  associate professor and guide  
Affiliation  Manipal academy of higher education 
Address  Department of medical surgical nursing Manipal college of nursing MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535687697  
Fax    
Email  daisy.j@manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pratheek 
Address  2nd year post basic BSc nursing student class room no 105 Manipal college of nursing(MCON) MAHE Manipal Udupi Karnataka India-576104 
Type of Sponsor  Other [self] 
 
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 Daisy j lobo  Manipal college of nursing  Dept of medical surgical nursing 1st floor Manipal college of nursing (MCON) Manipal academy of higher education MAHE Udupi Karnataka India-576104
Udupi
KARNATAKA 
9535687697

daisy.j@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  The students who are available during the study.
Students who are not willing to provide information.
 
 
ExclusionCriteria 
Details  Students who are not willing to provide information.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Based on the generated data the curricular modifications could be done by integrating LGBTQAI+ oriented syllabus. These initiatives may enhance the social acceptance status of (LGBTQAI+) among the nursing students   10 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="309"
Sample Size from India="309" 
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 Enrollment (India)   18/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   A descriptive study to assess the social acceptance and awareness of health needs of lesbian gay bisexual transgender asexual and intersex ( LGBTQAI+) population as perceived by the nursing students .The study finding would help to assess the social acceptance and awareness of health needs of LGBTQAI+ among the undergraduate nursing students and based on the generated data the curriculum modification could be done by integrating LGBTQAI+ oriented syllabus these initiatives may enhance the social acceptance status of LGBTQAI+ among the nursing students.  
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