| 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
|
|
|
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
|
|
|
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. |