| CTRI Number |
CTRI/2018/12/016546 [Registered on: 06/12/2018] Trial Registered Prospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Non Suicidal Self-Injury behavior and emotional dysregulation among collge students |
|
Scientific Title of Study
|
A study to assess the Non Suicidal Self-Injury (NSSI) behavior and emotional dysregulation among college students of selected colleges in Udupi district, Karnataka, with a view to develop an information booklet on emotion regulation strategies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Samanta |
| Designation |
MSc. Nursing second year student |
| Affiliation |
Manipal College Of Nursing |
| Address |
MSc. Nursing second year, Mental Health Nursing department,Manipal College Of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9903736892 |
| Fax |
|
| Email |
manishasamanta2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjalin Dsouza |
| Designation |
Assistant professor senior scale |
| Affiliation |
Manipal College Of Nursing |
| Address |
Assistant professor senior scale, Child Health Nursing department,Manipal College Of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
98453780988 |
| Fax |
|
| Email |
Anjeline.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Samanta |
| Designation |
MSc. Nursing second year student |
| Affiliation |
Manipal College Of Nursing |
| Address |
MSc. Nursing second year, Mental Health Nursing department,Manipal College Of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9903736892 |
| Fax |
|
| Email |
manishasamanta2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manisha Samanta, MSc Nursing second year student, MCON, Manipal, MAHE, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Manisha Samanta |
| Address |
MSc. Nursing second year, Mental Health Nursing department, Manipal College of Nursing, Manipal, MAHE,Manipal,Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manisha Samanta |
Government First Grade College Hiriadka, Udupi, Karnataka |
Agumbe - Udupi Hwy, Hiriadka, Karnataka 576113
Udupi
KARNATAKA |
9903736892
manishasamanta2001@gmail.com |
| Manisha Samanta |
Hebri Government First Grade College, Udupi, Karnataka |
Government First Grade College
Hebri Post
Karkala Taluk
Udupi District
Karnataka 576112
India
Udupi
KARNATAKA |
9903736892
manishasamanta2001@gmail.com |
| Manisha Samanta |
Shirdi Sai Degree college, Karkala, Udupi, Karnataka |
Suvarna Bhoomi Campus, Near Shirdi Sai Baba Mandira, Pervaje, Karkala, Karnataka 574104
Udupi
KARNATAKA |
9903736892
manishasamanta2001@gmail.com |
| Manisha Samanta |
Sri Bhuvanendra Degree College, Karkala, Udupi, Karnataka |
College Road, Karkala, Karnataka 574104
Udupi
KARNATAKA |
9903736892
manishasamanta2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and KLasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Suicidal Self-Injury |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
College students aged between 18 to 24 years who are present in class during the time of data collection and willing to participate in research study |
|
| ExclusionCriteria |
| Details |
Students who have known diagnosis of psychotic disorder, pervasive developmental disorder, stereotyped movement disorder with self-injury, or trichotillomania |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Non Suicidal Self-Injury
Emotional dysregulation |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Non Suicidal Self-Injury
Emotional dysregulation |
Once |
|
|
Target Sample Size
|
Total Sample Size="896"
Sample Size from India="896"
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)
|
01/01/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
once and publication not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The descriptive survey is to assess Non Suicidal Self-Injury (NSSI) behavior and difficulties in emotional regulation among students of 18 to 24 years of age group of selected colleges of Udupi district, Karnataka.This study may provide valuable information regarding NSSI behavior and its association with emotional dysregulation as well as specific factors which will help to empower the individual and the community to safe guard their own mental and physical health.Further the study aims at developing an information booklet for the students to help them in using healthy strategies to diffuse or moderate negative emotions. |