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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 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

 
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