| CTRI Number |
CTRI/2025/09/095324 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep quality Cardiac health and Quality of life among fishermen |
|
Scientific Title of Study
|
A Descriptive Study to Assess the Sleep Quality Cardiac health and
Quality of life Among Fishermen in Selected Areas of Udupi District |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananya T Maindan |
| Designation |
MSc Nursing Student |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka India |
| Address |
4rth floor
Room no 400
Dept of Community Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi Karnataka
576104
Udupi KARNATAKA 576104 India |
| Phone |
9880983158 |
| Fax |
|
| Email |
ananyatmaindan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Malathi G Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal Udupi |
| Address |
1st Floor
Department Of Community Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi Karnataka
576104
Udupi KARNATAKA 576104 India |
| Phone |
9449586431 |
| Fax |
|
| Email |
malathi.nayak@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Maria Pais |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Nursing MAHE Manipal Udupi |
| Address |
5th Floor
Department of Obstetrical and Gynecological Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi Karnataka
576104
Udupi KARNATAKA 576104 India |
| Phone |
9880873560 |
| Fax |
|
| Email |
maria.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing
Manipal Academy of Higher Education
Manipal Udupi Karnataka
India 576104 |
|
|
Primary Sponsor
|
| Name |
Ananya T Maindan |
| Address |
MSc Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
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 |
| Ananya T Maindan |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
4th Floor
Room No 400
Dept of Community Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
576104 Udupi KARNATAKA |
9880983158
ananyatmaindan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Fishermen who
reside in Udupi and fishing is an occupation
are available during the time of data collection
are willing to participate in the study
understand and speak/write in Kannada or local language
have minimum one year of working experience as a fisherman. |
|
| ExclusionCriteria |
| Details |
Fishermen who have the history of mental or psychiatric health disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study purpose is to evaluate the sleep quality among fishermen and its impact on their cardiac health and their quality of life By identifying patterns and correlations the study aims to provide insights into the significance of adequate sleep in promoting cardiovascular health Quality of Life and to contribute to the development of targeted health interventions for this occupational group |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="482" Sample Size from India="482"
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)
|
01/11/2025 |
| 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="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 A Descriptive Study to Assess the Sleep Quality Cardiac Health and Quality of Life Among Fishermen in Selected Areas of Udupi District The purpose of the study is to reduce the cardiovascular disease burden there is a need to comprehensively understand the profile of risk factors of CVDs which in turn will help to develop appropriate intervention strategies Hence this study was planned to ascertain the impact of sleep quality on cardiovascular health outcomes and quality of life among fishermen The findings from this research will provide insights into the relationship between sleep and heart health and quality of life in this community contributing to targeted interventions to improve overall health and wellbeing The objectives of the study are to assess sleep quality among fishermen using a Pittsburgh sleep quality index assess the quality of life among fishermen using a WHOQOLBREF scale assess the cardiac health among fishermen by using structured Cardiac health questionnaire find the relationship between sleep quality and cardiac health among fishermen find the relationship between sleep quality and quality of life among fishermen Quantitative research approach and descriptive cross sectional survey design will be used to collect the data by using purposive sampling technique from 482 fishermen working in Malpe harbour Population are fishermen and samples are fishermen who reside in Udupi and fishing is an occupation aged between 25 to 65 years The research instruments will be used for the study are demographic proforma Pittsburgh sleep quality index Cardiac health questionnaire WHOQOL BREF Scale The validity of tools was established by the five experts Pretesting will be conducted among five participants and the reliability of the tool will be established by administering it to 20 participants The pilot study will be conducted among 48 samples after obtaining formal administrative permission from the authority concerned Main data collection is planned after getting approval from administrative permission CTRI registration and informed consent from each participants after explaining the subject information sheet After getting informed consent demographic proforma Pittsburgh Sleep Quality Index Cardiac health questionnaire WHOQOL BREF scale tools will be administered to the participants The data will be analysed by using descriptive and inferential statistics based on objectives of the study Descriptive statistics Frequency percentage distribution mean standard deviation was used to analyse demographic characteristics and sleep quality Inferential Statistics Pearsons correlation coefficient formula will be used to find the relationship between sleep quality and cardiac health sleep quality and quality of health among fishermen |