| CTRI Number |
CTRI/2024/07/070906 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the relationship between knowledge of mental health and quality of life among professional nurses |
|
Scientific Title of Study
|
Relationship between mental health literacy and quality of life among nursing professionals in a tertiary care hospital Mangaluru. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lucy P Solo |
| Designation |
1st year MSc Nursing Student |
| Affiliation |
Father Muller college of nursing Kankanady Mangalore |
| Address |
Department of Mental Health Nursing, Father Muller College of Nursing Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9089447989 |
| Fax |
|
| Email |
sololucy720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Agnes EJ |
| Designation |
Professor and Guide |
| Affiliation |
Father Muller College of nursing Kankanady Mangalore |
| Address |
Department of Mental Health Nursing, Father Muller College of nursing
Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sabeena MTP |
| Designation |
Assistant professor and Co- Guide |
| Affiliation |
Father Muller College of nursing Kankanady Mangalore |
| Address |
Department of Mental Health Nursing, Father Muller College of nursing
Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7337875557 |
| Fax |
|
| Email |
sabeena14@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller college of nursing Kankanady, Mangalore 575002 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Lucy P Solo |
| Address |
Father Muller college of nursing Kankanady Mangalore 575002 |
| 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 Agnes EJ |
Father Muller Medical College Hospital |
Department of Psychiatry, Room no 42, Mangalore
Dakshina Kannada
KARNATAKA |
8050157831
agnesej2011@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nursing professionals
1. With at least six months of working experience.
2. With the designation of staff nurse or ward-in-charge. |
|
| ExclusionCriteria |
| Details |
1. Those working in psychiatric wards
2. Those completed post-graduation or diploma in psychiatric nursing
3. Those with chronic physical ( chronic renal disorders, severe cardiac problems, cancer) or
psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant relationship between mental health literacy and quality of life among nursing professionals. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant association of quality of life of nursing professionals with their baseline variables |
8 months |
|
|
Target Sample Size
|
Total Sample Size="368"
Sample Size from India="368"
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)
|
06/01/2025 |
| 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="2"
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
|
This study is a cross sectional, randomized, descriptive correlation to determine the association between Mental Health Literacy and Quality of Life among nursing professionals that will be conducted in a tertiary care hospital Mangaluru. The primary outcome measures will be Mental Health Literacy vary among nursing professionals and influence their quality of life. A simple random technique will be used in the selection of the subjects and the calculated sample size is 368. Baseline proforma, Mental Health Literacy scale, and WHOQOL-BREF will be used for data collection. To analyze the correlation between Mental Health Literacy and Quality of Life among nursing professionals Pearson’s correlation coefficient (r) will be utilized. To find out their association with the selected baseline variables, Chi-square analysis will be used. Using tables and figures, the findings of the study will be presented. |