| CTRI Number |
CTRI/2025/02/080179 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand how undergraduate students in professional colleges interact with others, how anxious they feel in social situations, and the quality of their relationships with people. |
|
Scientific Title of Study
|
A descriptive study to assess social interaction anxiety, and interpersonal relationship among students studying in selected professional colleges of Udupi, Taluk |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aminath Sima |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Child Health Nursing.Manipal College of Nursing.Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8296746198 |
| Fax |
|
| Email |
anthsima5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjalin DSouza |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Child Health Nursing.Manipal College of Nursing.Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845378098 |
| Fax |
|
| Email |
anjeline.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjalin DSouza |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Child Health Nursing.Manipal College of Nursing.Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845378098 |
| Fax |
|
| Email |
anjeline.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Child Health Nursing/Manipal College of Nursing/Madgav Nagar/Eshwar Nagar/Manipal/Karnataka/576104/India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing |
| Address |
Department of pediatric nursing/Manipal college of nursing/Madhav Nagar/Eshwar Nagar/Manipal/Karnataka/576104/India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali D Souza |
Manipal College of Nursing |
9Q3Q+J5Q, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9845378098
anjeline.d@manipal.edu |
| Dr Anjalin D Souza |
Manipal College of Pharmaceutical Sciences |
College of Pharmaceutical Sciences, Madhav Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9845378098
anjaline.d@manipal.edu |
| Dr Anjalin D Souza |
Manipal Institute of Communication |
8QXR+F34, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9845378098
anjaline.d@manipal.edu |
| DrAnjlin D Souza |
Manipal Institute of Technology |
Udupi-Karkala Rd.Eshwar Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9845378098
anjeline.d@manipal.edu |
| Dr Anjalin D Souza |
Welcome Graduate School of Hotel Administration |
9Q4R+4G4, Udupi-Hebri rd, near Kasturba Hospital, Sarlabettu, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9845378098
anjaline.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. who are studying in professional colleges
2. who give consent to participate in the study
3. who are between the age group of 18-25 years of age
4. sudents who will be available during data collection
5. sudents studying in the first year of the selected course |
|
| ExclusionCriteria |
| Details |
students who are identified with diagnosed psychological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measures will assess the levels of social interaction anxiety, the quality of interpersonal relationships among students, and the factors influencing both these aspects among undergraduate students in selected colleges. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the relationship between the selected demographic data & social interaction anxiety |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
21/02/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study employs a quantitative, cross-sectional descriptive survey design to collect and analyze data based on current conditions. It will be conducted in selected professional colleges in Udupi Taluk, targeting undergraduate students aged 18-25 years who are accessible during data collection. Sampling Methodology: - Purposive sampling will be used to select colleges.
- After determining the total number of first-year undergraduate students in these colleges, proportionate stratified sampling will be applied to select participants from each college.
- Students will be administered the tools, one demographic pro forma, and three rating scales.
Objectives: The objectives of this study are to: I. assess the social interaction anxiety among students studying in selected professional colleges by using the Social Interaction Anxiety Scale (SIAS). II. evaluate the level of interpersonal relationships among students studying in professional colleges by using the FIAT-Q-SF Interpersonal Relationships Questionnaire- Short Form. III. identify the factors influencing interpersonal relationships using a self-structured questionnaire. IV. analyze the relationship between social interaction anxiety and interpersonal relationships among students in selected professional colleges. V. find out the association between social interaction anxiety and selected demographic factors.
Detailed description of procedure / processes: After receiving approval from the Department of Pediatric Nursing, the study proceeded to obtain approval from the Institutional Research Committee (IRC). Subsequently, permission was sought from the Dean of Manipal College of Nursing for administrative support. Additional permissions were also obtained from the heads of relevant institutes and colleges. The next steps involve obtaining approval from the Institutional Ethics Committee (IEC) and completing registration with the Clinical Trials Registry-India (CTRI). Data collection will commence upon receiving IEC approval and completing CTRI registration |