| CTRI Number |
CTRI/2022/08/044887 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
14/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mental health problems among the patients accessing care at health centers |
|
Scientific Title of Study
|
Common mental health problems among patients accessing care at Ayurvedic health centers in Udupi Taluk. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surekha Devadasa Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Anatomy
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy of Higher Education
Madhav Nagar, Manipal
Udupi District, Karnataka State
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9538417513 |
| Fax |
|
| Email |
surekha.shetty@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Surekha Devadasa Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Anatomy
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy of Higher Education
Madhav Nagar, Manipal
Udupi District, Karnataka State
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9538417513 |
| Fax |
|
| Email |
surekha.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Surekha Devadasa Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Anatomy
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy of Higher Education
Madhav Nagar, Manipal
Udupi District, Karnataka State
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9538417513 |
| Fax |
|
| Email |
surekha.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Melaka Manipal Medical College (Manipal Campus) |
|
|
Primary Sponsor
|
| Name |
Surekha Devadasa Shetty |
| Address |
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy of Higher Education
Madhav Nagar, Manipal
Udupi District, Karnataka State
India.
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Surekha Devadasa Shetty |
Melaka Manipal Medical College (Manipal Campus) |
Department of Anatomy, MMMC, Room No- 129, Manipal Academy of Higher Education
Madhav Nagar, Manipal.
Udupi
KARNATAKA |
9538417513
surekha.shetty@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevalence of mental health problems |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All Patients and their bystander aged 18 years and above visiting selected Ayurvedic health centers in Udupi Taluk |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of the people with stress and depression and its associated factors will be identified. |
September 2022 to October 2022 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors influencing the stress and depression among the patients |
November 2022 to December 2022 |
|
|
Target Sample Size
|
Total Sample Size="423"
Sample Size from India="423"
Final Enrollment numbers achieved (Total)= "423"
Final Enrollment numbers achieved (India)="423" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2022 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The COVID-19 pandemic had a significant negative impact on the mental health of healthcare professionals and public. Mental health is considered to be the most essential condition for a good quality of life. The pandemic has been escalating and threatening the welfare of human beings globally, and this public health emergency generates fear and leads to a spectrum of psychological consequences ranging from distress responses such as anxiety, depression. So current study was undertaken to investigate the impact of COVID-19 on mental health during COVID-19 pandemic among patients and their bystander accessing care at Ayurvedic health centers. |