| 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
|
|
|
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
|
|
|
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 |