| CTRI Number |
CTRI/2019/01/017131 [Registered on: 17/01/2019] Trial Registered Prospectively |
| Last Modified On: |
16/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
clinical
practice barriers, stress and coping strategies- undergraduate
nursing students |
|
Scientific Title of Study
|
“A descriptive correlative study to assess the challenges in clinical
practice, level of stress and coping mechanisms used in undergraduate nursing students of
selected nursing colleges Udupi taluk Karnataka.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Pooja Bakshi |
| Designation |
MSc. Nursing second year student |
| Affiliation |
Manipal College Of Nursing, Manipal,MAHE,Manipal |
| Address |
MSc Nursing second year student, Mental Health Nursing department, Manipal College Of Nursing, Manipal, Manipal Academy Of Higher Education, Manipal, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9836825660 |
| Fax |
|
| Email |
poo.pooja.bakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Anil Raj |
| Designation |
Lecturer |
| Affiliation |
Manipal College Of Nursing, Manipal,MAHE,Manipal |
| Address |
Lecturer, Medical Surgical Nursing department, Manipal College Of Nursing, Manipal, Manipal Academy Of Higher Education, Manipal, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7411892986 |
| Fax |
|
| Email |
anilrajan1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Anil Raj |
| Designation |
Lecturer |
| Affiliation |
Manipal College Of Nursing, Manipal,MAHE,Manipal |
| Address |
Lecturer, Medical Surgical Nursing department, Manipal College Of Nursing, Manipal, Manipal Academy Of Higher Education, Manipal, Karnataka
Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7411892986 |
| Fax |
|
| Email |
anilrajan1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pooja Bakshi, MSc. Nursing second year student, MCON, Manipal, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Ms Pooja Bakshi |
| Address |
Manipal College of Nursing, MAHE,Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Pooja Bakshi |
Dhanvantari College of Nursing |
Vasundara Nagar, Malpe, Ashirvad Road, Santhekatte , Udupi
Udupi
KARNATAKA |
9836825660
poo.pooja.bakshi@gmail.com |
| Pooja Bakshi |
Manipal College of Nursing |
Madhav Nagar, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA |
9836825660
poo.pooja.bakshi@gmail.com |
| Pooja Bakshi |
Vidya College of Nursing Kaup |
PB No:15, Main Road, Kaup , Udupi
Udupi
KARNATAKA |
9836825660
poo.pooja.bakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethiucs Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
stress |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
3rd & 4th year undergraduate nursing students who are exposed in clinical area.
3rd & 4th year undergraduate nursing students who are doing shifting duty. |
|
| ExclusionCriteria |
| Details |
1 st and 2nd year undergraduate nursing students as they are not doing shifting duty. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
challenges in clinical
practice,level of stress and coping mechanisms |
1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
30/01/2019 |
| 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="1"
Months="0"
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)?
|
|
Brief Summary
|
This study is aimed to find out the various
challenges faced by the BSc nursing students and due to these challenges the
level of stress in their life and how they cope up with it.The objective of the study is to identify
the correlation between challenges, stress and coping strategies in undergraduate
nursing students of selected nursing colleges of Udupi, Karnataka.After obtaining ethical consideration,Informed consent will be taken from each participant. Potential benefits and risks will be informed to participants and data will be collected from them. |