| CTRI Number |
CTRI/2018/12/016726 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
18/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A research study to understand the possible psychological and social reasons why people attempt suicide by interviewing patients who were admitted for Intentional Self Harm in a tertiary level hospital in Udupi, Karnataka. |
|
Scientific Title of Study
|
Psychosocial factors of patients admitted for Intentional Self Harm at a tertiary level hospital in Udupi District, Karnataka: 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 |
Alen Chandy Alexander |
| Designation |
M.Phil. Psychiatric Social Work Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry
Kasturba Medical College, Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8884843986 |
| Fax |
|
| Email |
alenalex33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Assistant Professor, Psychiatric Social Work |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry
Kasturba Medical College, Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8884843986 |
| Fax |
|
| Email |
sanjeeva222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Assistant Professor, Psychiatric Social Work |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry
Kasturba Medical College, Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8884843986 |
| Fax |
|
| Email |
sanjeeva222@gmail.com |
|
|
Source of Monetary or Material Support
|
| T. C. Alexander
F/o Alen Chandy Alexander
Thengumpallil (H)
Punnaveli P. O. (Via Tiruvalla) 689589
Nedumkunnam, Kottayam |
|
|
Primary Sponsor
|
| Name |
Alen Chandy Alexander |
| Address |
Department of Psychiatry
Kasturba Medical College, Manipal
Udupi, Karnataka 576104 |
| 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 |
| Alen Chandy Alexander |
Kasturba Medical College and Kasturba Hospital, Manipal |
Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA |
884843986
alenalex33@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: X71-X83||Intentional self-harm, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Admitted for ISH who will give their informed consent to participate in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify if there is any relationship between Suicidal Intent, Life Events, Family Interaction, Coping Styles, Social Support & Quality of Life with the event of intentional self harm. |
After data collection has reached saturation point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide primary psychosocial interventions for patients if needed. |
As soon as subjects report any psychosocial or behavioral indicators towards need for intervention. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/12/2018 |
| 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
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a purposive, cross sectional research assessing psychosocial factors such as suicidal
intent, family environment, stressful life events, perceived social support, coping styles and quality of life of patients admitted for Intentional Self Harm in a tertiary level hospital in Udupi, Karnataka state of India. Scales such as Suicide Intent Scale (Beck,
Herman & Schuyler, 1973), Family Interaction Pattern Scale (Bhatti, R. S,
Krishna, D. K. S. & Ageira, B. L., 1986), Presumptive Stressful Life Events Scale Singh et. al,
1984), COPE Inventory (Carver, C. S., Scheier, M. F.
& Weintraub, J. K., 1989), Multi-Dimensional
Scale for Perceived Social Support (Zimet,
Dahlem, Zimet & Farley, 1988) & WHO Quality of Life – Bref
(World Health Organisation) will be used for data collection and the data shall be analysed using the Statistical Package for Social Sciences to study correlation between the variables. |