| CTRI Number |
CTRI/2024/05/067490 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stress level and coping strategies of nursing students |
|
Scientific Title of Study
|
A cross-sectional study to assess the stress levels and coping strategies among nursing students of selected nursing institutions of Udupi district, Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Sitta Ann Sabu Theradiyil |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College Of Nursing(MCON) Manipal academic of higher education(MAHE) Manipal
Kamraj Hostel, Madhav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6238554396 |
| Fax |
|
| Email |
sitta.theradiyil@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daisy J Lobo |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Nursing |
| Address |
Dept of Medical Surgical Nursing 1st floor Manipal College Of Nursing(MCON) Manipal academic of higher education(MAHE) Manipal
Nil
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
daisy.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Rishmitha |
| Designation |
Lecturer |
| Affiliation |
Manipal College Of Nursing |
| Address |
Dept of Medical Surgical Nursing 1st floor Manipal College Of Nursing(MCON) Manipal academic of higher education(MAHE) Manipal
Nil
Udupi
KARNATAKA
576104
India |
| Phone |
7760245265 |
| Fax |
|
| Email |
rishmitha.mcon@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College Of Nursing
Manipal School Of Nursing
Mitra School Of Nursing
Dhanvantri College And School Of Nursing
Adarsha College Of Nursing
|
|
|
Primary Sponsor
|
| Name |
Ms Sitta Ann Sabu Theradiyil |
| Address |
Manipal College Of Nursing(MCON) Manipal academic of higher education(MAHE) 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 |
| Dr Daisy J Lobo |
Manipal College Of Nursing |
Department Of Medical Surgical Nursing, Manipal College Of Nursing MCON,MAHE
Udupi
KARNATAKA |
953587697
daisy.j@manipal.edu |
|
|
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 |
| Healthy Human Volunteers |
Stress level |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Nursing students of selected colleges of Udupi.
Those who are available during the study who had minimum of 8 weeks of clinical exposure. |
|
| ExclusionCriteria |
| Details |
Nursing students who are not willing to participate.
Nursing students who are not available during the time of data collection.
Those who are already diagnosed with any chronic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stressors are multifactorial.
Stress may affect the academic performance of nursing students. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increase in stress levels can influence patient care activities of nursing students.
Copying strategies can influence stress by reducing the level of stress. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
26/05/2024 |
| 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="0"
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 to assess the stress levels and coping strategies among nursing students of selected nursing institutions of Udupi District Karnataka. The study outcomes are to identify the stress levels of nursing students as measured by stress level tool. Assess the coping strategies of nursing students as measured by coping strategies tool and to find an association between level of stresses and selected demographic variables. |