| CTRI Number |
CTRI/2024/03/064904 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How People Cope and Their Stress Levels After Surviving a Landslide in Kodagu District for Five Years |
|
Scientific Title of Study
|
Post-Traumatic Stress Disorder and Coping Strategies Among Landslide Survivors After Five Years in Kodagu. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashashwini A |
| Designation |
Post Graduate Student |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
Department of Public Health
K S Hegde Medical Academy
NITTE (Deemed to be University)
Nityanandanagar post, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8296959255 |
| Fax |
|
| Email |
yashashwinianethyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Reni N |
| Designation |
Assistant Professor |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
Department of Public Health
K S Hegde Medical Academy
NITTE (Deemed to be University)
Nityanandanagar post, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
rinibattya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Reni N |
| Designation |
Assistant Professor |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
Department of Public Health
K S Hegde Medical Academy
NITTE (Deemed to be University)
Nityanandanagar post, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
rinibattya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health
K S Hegde Medical Academy
NITTE (Deemed to be University)
Nityanandanagar post, Deralakatte, Mangaluru - 575018
|
|
|
Primary Sponsor
|
| Name |
Yashashwini A |
| Address |
Department of Public Health
K S Hegde Medical Academy
NITTE (Deemed to be University)
Nityanandanagar post, Deralakatte, Mangaluru
575018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rini N |
K S Hegde Medical Academy |
2nd Floor
Department of Public Health
Nityanandanagar post, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA |
9447394613
rinibattya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical Academy , Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
post traumatic stress disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Landslide survivors of the year of the disaster 2018 and residing in the resettlement area Landslide survivors aged 18 and above will be included in the study. |
|
| ExclusionCriteria |
| Details |
Individuals suffering from any psychiatric illness and taking medication
Any members who were not direct victim of the landslide, and joined the family later and currently living with them
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post-traumatic stress disorder and coping strategy among landslide survivors of Kodagu district |
in 2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| landslide related factors and socio demographics factors associated with PTSD and coping startergy |
in 2 month |
|
|
Target Sample Size
|
Total Sample Size="347"
Sample Size from India="347"
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)
|
08/04/2024 |
| 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="2"
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
|
This research delves into the current prevalence of PTSD and coping mechanisms five years after the disaster. By retrospectively examining the experiences of those impacted, the study aims to shed light on the lasting effects on mental well-being and the strategies employed for resilience. This insight will contribute to a nuanced understanding of the prolonged challenges faced by survivors, informing the development of targeted support for individuals navigating the aftermath of such traumatic events. This is a community-based cross-sectional study aimed to assess the PTSD and coping strategies among Survivors of the 2018 landslide and now residing in a resettlement area in Kodagu District, Karnataka. The study period will extend from October 2023 to July 2024, with data collection scheduled for April 2024 and May 2024.
|