| CTRI Number |
CTRI/2019/02/017833 [Registered on: 26/02/2019] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing stress and stressors among nursing students |
|
Scientific Title of Study
|
Study to assess stress and stressors among the UG nursing students in a selected college at Mangaluru |
| Trial Acronym |
stress, stressors |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHEL CHRISTAL PINTO |
| Designation |
Student |
| Affiliation |
Father Muller College of NUrsin |
| Address |
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9449676938 |
| Fax |
|
| Email |
ashelpinto27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Precilla DSilva |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9731873891 |
| Fax |
|
| Email |
precilladsilva25@fathermuler.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashel Pinto |
| Designation |
student |
| Affiliation |
|
| Address |
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9449676938 |
| Fax |
|
| Email |
ashelpinto27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashel Pinto |
| Address |
Father Muller college of nursing
Father Muller Road
Kankandy
Mangaluru |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Ashel Pinto |
Father Muller College of Nursing |
Father Muller Road
kankanady
Mangaluru
Dakshina Kannada
KARNATAKA |
9449676938
ashelpinto27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Medica Colege Institutional Ethics Commite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy student nurses |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Student nurses who are studying their I, II, III and IV-year nursing course |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study expects that student nurses will have severe level of stress and the associating factors could be academic family or clincals |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study expects there will be association of some of the variables with stress level |
5 days |
|
|
Target Sample Size
|
Total Sample Size="197"
Sample Size from India="197"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2018 |
| Date of Study Completion (India) |
31/07/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
after completion of the study publication will be done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study would like to emphasize that undergraduate nursing students will exhibit more stress due to various fcators. The early identification will help us to find the coping strategies for it.
|