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CTRI Number  CTRI/2024/10/074601 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding How Workplace Environment Impacts the Well-being of Healthcare Workers in India 
Scientific Title of Study   Assessing the Impact of Organizational Culture on Healthcare Workers in India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gagan shettigar 
Designation  Student 
Affiliation  Manipal academy of higher education 
Address  Department of Healthcare and Hospital Management, No division Room no LH 3
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka,India
Udupi
KARNATAKA
576104
India 
Phone  9535102124  
Fax    
Email  gagan.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Swathi.ks 
Designation  Associate professor 
Affiliation  Manipal academy of higher education 
Address  Department of Healthcare and Hospital Management, No division Room no 56
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka,India
Udupi
KARNATAKA
576104
India 
Phone  9535102124  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Gagan shettigar 
Designation  Student 
Affiliation  Manipal academy of higher education 
Address  Department of Healthcare and Hospital Management, No division Room no LH 3
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9535102124  
Fax    
Email  gagan.psphmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Assessing the Impact of Organizational Culture on Healthcare Workers in India, is conducted with the infrastructural support provided by Prasanna School of Public Health. 
 
Primary Sponsor  
Name  Gagan 
Address  Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India 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 
Dr Usha rani  prasanna school of public health  Department of Health Care and Hospital Management, No division, Room no 68
Udupi
KARNATAKA 
8310214742

usha.rani@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Instituional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  workplace stress,worklife imbalace 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthcare professionals:
(Surgeons, physicians, nurses, and allied health workers) employed in private healthcare facilities in India.
• At least a year of work experience in the healthcare sector. Participants must be able to understand and respond to the survey in English. This ensures that only those who understand English will participate in the study.
 
 
ExclusionCriteria 
Details  Healthcare professionals in administrative or non-clinical roles.
•People with less than one year of work experience in the healthcare sector.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
25 questions related to pressure levels and personal-professional harmony will be given to each participant, and the outcome will be determined using the data gathered. from the questionnaire  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific intervention or endpoint criteria, as this is an observational study focused on assessing pressure levels & Personal-Professional Harmony. The proposed study procedures are non-invasive & do not involve additional tests or interventions beyond the standard practices of the participating healthcare facilities  8 weeks 
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
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)   11/10/2024 
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="0"
Months="6"
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  

Aim: This study examines organizational cultures’ influence on the experiences, well-being, and performance of healthcare workers in India.

 

Objectives:

 

1. To investigate the relationship between organizational cultures and important work-related outcomes for healthcare professionals, such as job satisfaction, pressure levels, and Personal-Professional Harmony.

 

2. To Analyze the relationship between organizational cultures and the quality of patient care and healthcare service delivery.This research will use an observation-based, cross-sectional study design. The protocol for the study will be submitted  for approval from the Institutional Ethics Committee (IEC)

The study will utilize a snowball sampling technique to select a representative sample of healthcare workers. Surveys will be administered online via Google Forms.

·  PSS-10 (Perceived Stress Scale): The purpose of PSS-10 is to measure the perception of stress among individuals. While the PSS-10 does not directly measure organizational culture, it can reflect the impact of the organizational environment on healthcare workers. High levels of perceived stress can indicate a negative or high-pressure work culture, while lower stress levels might suggest a more supportive and positive culture.

·  Hayman Work-Life Balance Scale: This scale assesses how individuals feel they can balance their work and personal life. Work-life balance is closely tied to organizational culture. A culture that promotes work-life balance typically has policies that support employees’ personal lives, flexible working arrangements, and reasonable workloads. This scale helps you assess how the organizational culture impacts workers’ ability to maintain a healthy work-life balance.

These tools (PSS-10 and Hayman Work-Life Balance scale) primarily measure the effects of organizational culture on employees—specifically, how the culture impacts their stress levels and work-life balance. These outcomes are closely linked to managerial practices, leadership styles, communication, and overall work environment.

The PSS-10 and Hayman Work-Life Balance scales do not directly assess patient care; they are essential tools for evaluating the impact of organizational culture on healthcare workers. Stress levels and work-life balance are critical indicators of the organizational environment, indirectly influencing patient care.

 

The collected data analysis will be done using both descriptive and inferential statistics. Additionally, the study will gather data from healthcare workers across various institutions and hospitals in India rather than from a single study center. Participants who are not interested can stop answering the survey at any time, ensuring their confidentiality is maintained.

Participant Recruitment and Informed Consent: Healthcare professionals (Surgeons, nurses, and allied health workers) employed in the participating healthcare facilities will be informed about the study through direct communication. In-depth details regarding the study’s objectives, procedures, and potential risks and benefits will be provided to the participants. Informed consent must be provided online by study participants who consent to participate.

Data Collection: Demographic information: Participants will be asked to provide details such as age, gender, "job role," work experience, and work setting ( private healthcare facility). Data Analysis: Permission to use a questionnaire has been sought from the author. The quantitative data collected through the standardized questionnaires will be analyzed using appropriate statistical methods. Participants can withdraw from the study at any time without providing a reason. There are no specific intervention or endpoint criteria, as this observational study focused on assessing pressure levels and Personal-Professional Harmony. The proposed study procedures are non-invasive and do not involve additional tests or interventions beyond the standard practices of the participating healthcare facilities.

 
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