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CTRI Number  CTRI/2020/12/029584 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 30/11/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Effects of PPE among Healthcare Workers 
Scientific Title of Study   A study of physical and emotional effects of PPE among healthcare workers handling COVID 19 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swathy Moorthy 
Designation  Associate Professor 
Affiliation  Sri Ramachandra University 
Address  Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu

Chennai
TAMIL NADU
600116
India 
Phone  9444016401  
Fax    
Email  drswathymoorthy@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathy Moorthy 
Designation  Associate Professor 
Affiliation  Sri Ramachandra University 
Address  Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu


TAMIL NADU
600116
India 
Phone  9444016401  
Fax    
Email  drswathymoorthy@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Swathy Moorthy 
Designation  Associate Professor 
Affiliation  Sri Ramachandra University 
Address  Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu


TAMIL NADU
600116
India 
Phone  9444016401  
Fax    
Email  drswathymoorthy@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra University 
 
Primary Sponsor  
Name  Dr Swathy Moorthy 
Address  Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSPThiagarajan  Sri Ramachandra Medical College, SriRamachandra Institute of Higher Education and Research  Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu
Chennai
TAMIL NADU 
04445982665

deanresearch@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  doctors and nurses who handle COVID 19 patients and wear PPE for more than 2 hours duration 
 
ExclusionCriteria 
Details  healthcare workers who don the PPE for less than 2 hours duration 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge of the physical and emotional effects of PPE among the healthcare workers  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
knowledge of any adverse health outcomes among the healthcare workers due to the PPE  6 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/12/2020 
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   not yet published any 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Personal protective equipments (PPE) are an essential requirement for health care workers in hospitals during rapidly spreading pandemic times of Sars CoV2, Influenza etc. Despite the protective function of the PPE, the effects of wearing the PPE – on the respiratory microclimate, respiratory functions and the individual sensations are equally important. Studies have reported subjective discomfort feeling, increased humidity and heat perception, increased breath resistance with respirator usages and also affect the wearer’s whole body thermal sensation, Prolonged hours of using the PPE, may lead to physiological stress on the wearer, causing headaches and making their regular tasks challenging. These effects might be due to the alterations in the respiratory microenvironment surrounding the masks. Different temperatures and humidification are induced on the outer and inner sides of the masks owing the differences in the permeability of air and water vapour in the type of PPE used. Following prolonged hours of donning the PPE, the physiological functions of the nasal cavity may change due to different temperature and humidification conditions within the PPE. Moreover, the frontline health care workers face a lot of mental stress owing to the unprecedented pandemic. Front-line HCWs often suffer from anxiety, stress related disorders, insomnia, depression, burnout, etc. The risk of exposure to infection, availability of personal protective equipment, job-related stress, perceived stigma and psychological impact of the isolation/quarantine and interpersonal distancing, effective risk communication to HCWs are some of the common socio-economic factors that play a major role in the stress response of the HCWs. Existing literature supports that pandemic, apart from causing mortality and physical morbidities, also leads to tremendous mental health problems in the sufferers as well as in the noninfected public. Despite the huge magnitude of mental health problems among the front-line HCWs, their psychological health is often overlooked.

However, there is lack of studies on the post effects of PPE donning on the physical and mental well-being of the health care workers. With this hypothesis, we aim to study the physical effects of PPE donning on the HCWs and their apprehensions for the same. The findings will be useful for the development and formulation of guidelines and policies for longer duration of PPE usage 
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