| CTRI Number |
CTRI/2023/03/050920 [Registered on: 21/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Social anxiety disorder and its effect on the quality of life of adults having social anxiety disorder in Mangalore |
|
Scientific Title of Study
|
Social anxiety disorder and its relation to quality of life among the adults in Mangalore- A cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aajna A |
| Designation |
Student |
| Affiliation |
K.S Hegde Medical Academy |
| Address |
K.S Hegde Medical Academy
Department of Public Health
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8310569276 |
| Fax |
|
| Email |
aajnamunni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeby Jose Olickal |
| Designation |
Assistant professor |
| Affiliation |
K.S Hegde Medical Academy |
| Address |
K.S Hegde Medical Academy
Department of Public Health
Deralakatte, Mangalore
Department of Public Health
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09497885346 |
| Fax |
|
| Email |
drjebyjose.olickal@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aajna A |
| Designation |
Student |
| Affiliation |
K.S Hegde Medical Academy |
| Address |
K.S Hegde Medical Academy
Department of Public Health
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8310569276 |
| Fax |
|
| Email |
aajnamunni@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE (deemed to be) University
K.S Hegde Medical Academy
Deralakatte- 575018
Mangalore |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
K.S Hegde Medical Academy
Department of Public Health
Deralakatte, Mangalore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aajna A |
Jeppinamogaru |
Mangalore
Dakshina Kannada
KARNATAKA |
8310569276
aajnamunni@gmail.com |
| Dr Aajna A |
Konaje rural |
Ullal constituency
Mangalore
Dakshina Kannada
KARNATAKA |
8310569276
aajnamunni@gmail.com |
| Dr Aajna A |
Mangaladevi |
Mangalore
Dakshina Kannada
KARNATAKA |
8310569276
aajnamunni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| K.S Hegde Medical Academy, NITTE (deemed to be) University |
Approved |
| Mangalore corporation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
NA |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Social anxiety disorder and Quality of life |
Since it is a cross sectional study, outcome will be assessed only once. ie at the baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="401"
Sample Size from India="401"
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)
|
01/04/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a community-based cross-sectional analytical study to find the prevalence of social anxiety disorder in Mangalore, Karnataka. The study also aims to find the relation of social anxiety disorder with quality of life among adults aged 18 years and above residing in Mangalore. Data collection will be done in the month of April and May of 2023. The sample size of the study is 401 calculated using the prevalence of social anxiety disorder from the previous study conducted. The participants are chosen by simple random technique. The data on social anxiety disorder will be collected through Liebowitz social anxiety scale and quality of life will be collected through the WHO BREF questionnaire. Sociodemographic and behavioral factors from the study participants will also be collected by a validated questionnaire tool with written consent from the participants. The administration of questionnaire is in the local language Kannada. The data collected will be analyzed in STATA v.14. |