| CTRI Number |
CTRI/2021/04/033081 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Awareness and attitude towards ill effects of substance use among nursing students |
|
Scientific Title of Study
|
A study to assess the Awareness and attitude towards ill effects of substance use among students in selected nursing colleges of Udupi district, Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Preethi Amulya |
| Designation |
M Sc Nursing student |
| Affiliation |
Manipal college of nursing |
| Address |
Room no 402 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Room no 402 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8686201531 |
| Fax |
|
| Email |
preethiamulya59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binil V |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Nursing |
| Address |
Room no 603 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Room no 603 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844387432 |
| Fax |
|
| Email |
Vp.binil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
G Preethi Amulya |
| Designation |
M Sc Nursing student |
| Affiliation |
Manipal college of nursing |
| Address |
Room no 402 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Room no 402 Department of Psychiatric (Mental Health) Nursing Manipal Manipal College of Nursing Manipal Academy of Higher education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8686201531 |
| Fax |
|
| Email |
preethiamulya59@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Preethi Amulya |
| Address |
Manipal College of Nursing, Manipal, Manipal Academy of Higher
Education, Manipal |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anice George |
Manipal College of Nursing |
room no 101 Manipal college of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA |
9632094766
anice.george@manipal.edu |
| Dr Leena Sequira |
Manipal school of Nursing |
room no 504 Manipal School of Nursing Manipal Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA |
9481971214
leena.sequ@manipal.edu |
| Mrs Pavitra Nayak |
Udupi College of Nursing |
room no 402 Udupi college of Nursing Udupi
Udupi
KARNATAKA |
9900144978
nayakpavitra24@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
No Objection Certificate |
| Manipal school of nursing |
No Objection Certificate |
| Udupi college of nursing |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Students between 18-24 years of age
1st and 2nd year BSc nursing students
1st-year diploma nursing students
who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
students who are not available at the time of data collection
non-health professional students
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess the awareness towards ill effects of substance use among students in selected nursing colleges of Udupi district, Karnataka |
10-12-2020 to 17-11-2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess the attitude towards ill effects of substance use among students in selected nursing colleges of Udupi district, Karnataka |
10-12-2020 to 17-11-2021 |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
26/04/2021 |
| 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
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining permission from the concerned authorities and IEC approval CTRI registration, the sample will be obtained through the purposive sampling technique. Online survey forms will be created and links will be sent through email ids along with informed consent from the study participants |