| CTRI Number |
CTRI/2024/03/063751 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence Of Psychiatric Disorders In Admitted Patients |
|
Scientific Title of Study
|
A Study Of Major Psychiatric Comorbidities In Admitted Patients In Medicine, Surgery And Obstetrics And Gynaecology Department In KDMC Mathura |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravneet Kaur Brar |
| Designation |
Postgraduate Resident |
| Affiliation |
Kanti Devi Medical College Hospital and Research Center |
| Address |
Department of Psychiatry , Kanti Devi Medical College Hospital and Research Centre ,Akbarpur ,Chatta , Mathura
Mathura
UTTAR PRADESH
281406
India |
| Phone |
7696330499 |
| Fax |
|
| Email |
Ravneetbrar48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Singh |
| Designation |
Professor |
| Affiliation |
Kanti Devi Medical College Hospital and Research Center |
| Address |
Department of Psychiatry , Kanti Devi Medical College Hospital and Research Centre ,Akbarpur ,Chatta , Mathura
Mathura
UTTAR PRADESH
281406
India |
| Phone |
9389378122 |
| Fax |
|
| Email |
Shanky.gauravsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Singh |
| Designation |
Professor |
| Affiliation |
Kanti Devi Medical College Hospital and Research Center |
| Address |
Department of Psychiatry , Kanti Devi Medical College Hospital and Research Centre ,Akbarpur ,Chatta , Mathura
UTTAR PRADESH
281406
India |
| Phone |
9389378122 |
| Fax |
|
| Email |
Shanky.gauravsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kanti Devi Medical College Hospital and Research center |
|
|
Primary Sponsor
|
| Name |
Dr Ravneet Kaur Brar |
| Address |
Kanti Devi Medical College Hospital and Research center , Akbarpur , Chatta , Mathura |
| Type of Sponsor |
Other [Pg student] |
|
|
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 Ravneet Kaur Brar |
Kanti Devi Medical College Hospital and Research Center |
Department of psychiatry, room no 2237, Kanti Devi Medical College Hospital and Research Center, Akbarpur , Chatta , Mathura
Mathura
UTTAR PRADESH |
7696330499
Ravneetbrar48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committe Kanti Devi Medical College Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient and caregivers who give written and informed consent
Patient aged 18 yrs and above
Patient oriented to time , place and person
Pain scale rating less than 5
Patient admitted in medicine , surgery and obstetrics and gynaecology department in KDMC Mathura
Patient admitted for alteast 24 hrs
|
|
| ExclusionCriteria |
| Details |
Patient refuse to give consent
Patient less than 18 yrs
Known case of any Psychiatric illness will be presented as separate data points
Patient admitted in strict isolation by treating Doctor
Patient admitted in Intensive care
Patient kept under observation without admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of Major Psychiatric Comorbidities in patients admitted in Medicine, Surgery and Obstetrics / Gynaecology Departments in KDMC , Mathura |
Within 2 days of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the type & severity of Major Psychiatric illness in these patients
Comparing Psychiatric Disorder with Acute vs Chronic Medical Illness |
Within 2 days of admission |
|
|
Target Sample Size
|
Total Sample Size="306"
Sample Size from India="306"
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)
|
16/03/2024 |
| 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="1"
Months="6"
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
|
A Cross -Sectional Study will be conducted in admitted patients in Medicine , Surgery and Obstetrics / Gynaecology Department in KDMC , Mathura . After satisfying the defined the inclusion and exculsion criteria, patient will be enrolled for the study. Detailed History of the patient will be taken and recorded. Time taken for each case will be varied depending upon the level of the cooperation of the patient. All the patient with or without psychiatric illness will be screened by using MINI PLUS SCREEN 7.0.2 . Patient with any symptoms of psychiatric disorders as per MINI PLUS SCREEN , will further evaluate by Modules of MINI . Data will be collected from the patients using the mentioned proforma 1.) Socio-demographic performa- A semi – structured proforma will be used to collect detailed information about Socio demographic characteristics include age, sex, education, religious affiliation, marital status, household, employment, residence (urban/ rural/ tribal/ non tribal) and income. The performa will be used to assess various socio-demographic variable 2.) Mini International Neuropsychiatric Interview (MINI): It is a brief structured diagnostic interview in order to evaluate and diagnose the most common psychiatric disorders among patients 3.) Glasgow Coma scale : It is used to assess the person’s level of consciousness. It is based on Motor response, Eye opening and Verbal response. 4.) Visual Analogue Pain Scale :It is a Psychometric scale that is used to assess the varying degrees of pain experienced by the patients. |