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Discomfort in Use and Physical Disturbance of FFP2 Masks in a Group of Italian Doctors, Nurses and Nursing Aides during the COVID-19 Pandemic

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Face masks represent an effective COVID-19 mitigation strategy; this study investigated the quality in use of FFP2 masks in a group of 156 frontline HCWs recruited through a snowball procedure in northwest Italy. Participants filled out an online questionnaire (January 2022) on FFP2 sources of discomfort, physical disturbance at different anatomical points and suggestions for improvement. Most of the participants (69%) reported a feeling of protection and safety, but they also reported episodes of dyspnea (70%). The majority of glasses wearers (62%) reported fogging and displacement of their glasses. Humidity and heat were the main discomfort sources (39%), followed by elastic bands (32%). Physical disturbances were frequent and heavier on the ears, nose and cheekbones. Nursing aides and nurses perceived significantly more discomfort compared to doctors and nursing aides had the highest rate of physical disturbance. To address these issues, following participants’ suggestions, FFP2 masks should be redesigned to be more adjustable, with different sizes and softer fabrics. The investigation pointed out criticalities in the use of FFP2 masks related to different professional roles within the overall group of HCWs and stressed the need for an FFP2 human-centered design that accounts not only for physical needs but also for workload and task variability.
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Citation: Micheletti Cremasco, M.;
Vigoroso, L.; Solinas, C.; Caffaro, F.
Discomfort in Use and Physical
Disturbance of FFP2 Masks in a
Group of Italian Doctors, Nurses and
Nursing Aides during the COVID-19
Pandemic. Safety 2023,9, 40. https://
doi.org/10.3390/safety9020040
Academic Editor: Raphael Grzebieta
Received: 20 March 2023
Revised: 7 June 2023
Accepted: 9 June 2023
Published: 13 June 2023
Copyright: © 2023 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).
safety
Article
Discomfort in Use and Physical Disturbance of FFP2 Masks in a
Group of Italian Doctors, Nurses and Nursing Aides during the
COVID-19 Pandemic
Margherita Micheletti Cremasco 1, Lucia Vigoroso 2,3 ,* , Cristina Solinas 4and Federica Caffaro 2
1Department of Life Sciences and Systems Biology, University of Torino, Via Accademia Albertina 13,
10123 Turin, Italy; margherita.micheletti@unito.it
2Department of Education, Roma Tre University, Via del Castro Pretorio 20, 00185 Rome, Italy;
federica.caffaro@uniroma3.it
3Institute of Sciences and Technologies for Sustainable Energy and Mobility (STEMS), National Research
Council of Italy (CNR), Strada delle Cacce 73, 10135 Turin, Italy
4
Department of Psychology, University of Torino, Via Verdi 10, 10124 Turin, Italy; cristina.solinas@edu.unito.it
*Correspondence: lucia.vigoroso@uniroma3.it
Abstract:
Face masks represent an effective COVID-19 mitigation strategy; this study investigated the
quality in use of FFP2 masks in a group of 156 frontline HCWs recruited through a snowball procedure
in northwest Italy. Participants filled out an online questionnaire (January 2022) on FFP2 sources of
discomfort, physical disturbance at different anatomical points and suggestions for improvement.
Most of the participants (69%) reported a feeling of protection and safety, but they also reported
episodes of dyspnea (70%). The majority of glasses wearers (62%) reported fogging and displacement
of their glasses. Humidity and heat were the main discomfort sources (39%), followed by elastic bands
(32%). Physical disturbances were frequent and heavier on the ears, nose and cheekbones. Nursing
aides and nurses perceived significantly more discomfort compared to doctors and nursing aides had
the highest rate of physical disturbance. To address these issues, following participants’ suggestions,
FFP2 masks should be redesigned to be more adjustable, with different sizes and softer fabrics. The
investigation pointed out criticalities in the use of FFP2 masks related to different professional roles
within the overall group of HCWs and stressed the need for an FFP2 human-centered design that
accounts not only for physical needs but also for workload and task variability.
Keywords: COVID-19; face mask; healthcare workers; occupational safety; quality in use
1. Introduction
In January 2020, the World Health Organization (WHO) officially declared the emer-
gence of a novel coronavirus outbreak characterized by human-to-human transmission and
airborne droplet infection as a matter of international concern regarding public health [
1
].
Subsequently, the global spread of this infectious disease, known as COVID-19, was des-
ignated as a pandemic [
2
]. To curb the transmission of the causative agent, severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), the WHO promptly issued provisional
guidelines pertaining to the utilization of Personal Protective Equipment (PPE) [3].
In the scientific literature, Filtering FacePiece (FFP) masks are frequently denoted
as respirators or face filters to differentiate them from surgical masks and homemade
alternatives. International standards categorize respirators according to their filtration
efficiency and maximum total inward leakage, establishing three protection classes (FFP1,
FFP2 and FFP3), wherein the numerical values denote increasing levels of protection (i.e.,
1 = low > 80%, 2 = medium > 94% and 3 = high > 99%) [
4
]. Various reference standards,
such as EN 149-2001 for Europe, NIOSH-42CFR84 for the United States and GB2626-2006
for China, elucidate the classification, requisite performance criteria, distinctive attributes,
certification methodologies and practical applications of respirators. These standards
Safety 2023,9, 40. https://doi.org/10.3390/safety9020040 https://www.mdpi.com/journal/safety
Safety 2023,9, 40 2 of 16
enable cross-country comparisons of respirator models based on their stipulated physical
properties and performance characteristics. Consequently, the concurrence between FFP2
(Europe EN 149-2001), N95 (United States NIOSH-42CFR84) and KN95 (China GB2626-
2006) has been affirmed through conformity assessments [5].
From a safety standpoint, FFP2 masks, or their equivalents, have demonstrated the
capacity to filter out 95% of particles, thereby providing optimal protection. However,
the effectiveness of these masks relies heavily on correct usage and a secure fit to the
individual’s face. Achieving a proper seal necessitates the meticulous adaptation of the
masks to the user’s facial contours. The protective efficacy of respirators hinges upon their
comfort and ability to accommodate the anthropometric characteristics of the head and
face [
6
]. Inadequate comfort levels can result in improper or noncompliant mask usage,
thereby increasing the risk of viral transmission [7].
Healthcare workers (HCWs) were among the first individuals mandated to wear PPE
throughout their working hours, especially when attending to COVID-19 patients [
8
]. No-
tably, FFP2 masks, or their American and Chinese equivalents, emerged as the predominant
PPE employed in healthcare settings and their usage became mandatory in various other
contexts such as workplaces, crowded environments, public spaces and transportation,
owing to the pandemic [
9
]. HCWs have a higher risk of infection compared with the gen-
eral population [
10
] and exhibit a notable seroprevalence of SARS-CoV-2 antibodies [
11
].
The use of face masks in the context of the pandemic has demonstrated effectiveness in
reducing the risk of infection among HCWs by approximately 70% [7]. Nevertheless, sub-
optimal mask fit, prolonged wearing and associated discomfort significantly influence the
compliance of healthcare workers [12].
Regarding the comfort of FFP2 masks in the HCWs population, facial anthropometrics
play a pivotal role in determining the safety and performance of masks. Although this
PPE is designed to accommodate a wide range of individuals, the sizes and shapes of
masks do not adequately represent the variability in facial characteristics within different
user groups [
13
,
14
]. The existing literature suggests variation in facial anthropometric
measurements between males and females [
15
], with 14 measurements significantly smaller
among females [
16
]. While international standards for the mass production of respirators
in Europe (FFP2), USA (N95) and China (KN95) are currently being upheld [4], it appears
that the prevalent type of user considered during “fit-testing” primarily comprises white
males, neglecting individuals with facial dimensions falling outside the central percentiles
of the distribution of these measurements. As Carvalho and colleagues [
17
] demonstrated,
male healthcare workers exhibit a significantly higher likelihood of finding well-fitting
respirators and achieving successful fits on the first attempt than their female counterparts.
This observation should serve as a warning, considering that women constitute approxi-
mately 67% of the global workforce in the health and care sector [
18
]. Failure to account for
morphometric variability is one of the reasons HCWs frequently express discomfort with
masks [
19
21
] and, more importantly, this can compromise the fit performance, protection
and safety of respiratory PPE [16,22,23].
In addition to facial anthropometrics, other variables have emerged as critical factors
influencing the quality of use and effectiveness of FFP2 masks among HCWs. A recent
review [
11
] identified a correlation across multiple studies between obesity and reported
mask discomfort, which subsequently increased the risk of incorrect use and infection.
Furthermore, concerning weight conditions, as documented by Zhuang et al. [
15
], each
10 kg increase in weight significantly affects various facial measurements, except for nose
length, thereby potentially exacerbating associated issues.
In addition to the issue of ensuring adequate morphometric protection, another con-
cern arises regarding the physical discomfort that can be caused by prolonged mask usage,
resulting from contact or localized pressure. Rosner [
24
] conducted a study revealing that
extended use of FFP2 and surgical masks led to adverse physical effects such as headaches,
breathing difficulties, acne, skin abrasions, rashes, impaired cognition and disturbances
in vision, communication, speech and thermal balance. Furthermore, a recent review by
Safety 2023,9, 40 3 of 16
Silva and colleagues [
25
] demonstrated that masks, particularly of the FFP2 type, were the
primary contributors to the occurrence of skin lesions, followed by goggles, face shields
and gloves. Hu [
26
] demonstrated that, among healthcare workers (HCWs) who regularly
utilized FFP2 masks (averaging over 12 h per day for 3.5 months), more than 95% reported
some form of skin involvement, including nasal bridge ulcers associated with prolonged
use of personal protective equipment (PPE). Even when worn for fewer hours, the effects
persist, with symptoms reported by 47.3% of the study population when wearing masks
for more than four hours [
27
]. Consequently, wearing a mask for more than six hours and
contact with the mask material may heighten the risk of localized dermatitis and other
skin diseases [
28
,
29
]. Conversely, some authors found no correlation between mask usage
duration and subjective symptoms such as headaches, lightheadedness, breathlessness,
facial bruising, facial irritation, mental fatigue, physical fatigue and yawning [30].
Another under-explored factor is the association between age and mask-related issues.
While certain authors have observed a higher risk of dizziness, skin injuries and headaches
with increasing age [
31
], others have reported a negative correlation between age and
headaches [
32
]. It should be noted that most studies addressing the critical aspects of
mask usage in medical contexts have encompassed diverse healthcare professionals collec-
tively [
10
,
33
], whereas certain studies focused exclusively on surgeons [
20
,
34
] or nursing
staff [35,36].
Over the past three years, due to the ongoing pandemic, there have been periods
when the use of FFP2 masks was mandatory in work and social settings, alternating
with phases when it was strongly recommended for indoor and even outdoor activities.
Meanwhile, HCWs have consistently adhered to continuous and regulated mask usage,
both nationally and internationally [
37
]. This heightened level of attention is unsurprising
because, as early as May 2020, predictions were made that persistent or intermittent social
distancing measures would likely extend until 2022, with the possibility of resurgence
in contagion cases persisting until 2024 [
38
]. Consequently, the use of PPE, particularly
among healthcare professionals, continues to garner significant focus, especially regarding
enhancing tolerability and ensuring appropriate and safe usage during extended periods
of wear.
Context and Aims of the Study
The present investigation builds on the following:
(1) HCWs are particularly exposed to the risk of infection from COVID-19 and face masks
must not only have high filtration efficacy, but also fit securely and be comfortable to
wear and endure for long periods [39];
(2) Italy was the first European country to experience the spread of the SARS-CoV-2 virus
at the end of February 2020, with the northern regions being the most affected, also in
terms of mortality [40].
The Italian healthcare system was significantly burdened and HCWs reported physical
and mental exhaustion, the anguish of difficult triage decisions and the pain of losing
patients and colleagues, all in addition to the infection risk [
41
]. In early 2023, international
news spread about the possible risks due to a new pandemic wave; therefore, in Italy, there
were renewed indications of attention and extensions of the mandatory use of respirators in
certain contexts. As reported in the Ministerial Circular of the Ministry of Health [42], the
use of respiratory protective devices is mandatory for workers, users and visitors to health
and social care facilities, including hospitality and long-term care, nursing homes, hospices,
rehabilitation facilities, residential facilities, as defined in art. 44 of the Decree of the
President of the Council of Ministers of 12 January 2017. In accordance with the provisions
of the Decree of 31 October 2022, “Urgent Measures for the Containment and Management
of COVID-19 regarding the use of respiratory protective equipment” [
43
], these measures
have been extended until 30 April 2023 and extended to clinics and doctors’ offices.
Based on the previous considerations, the present study aimed to explore the quality
in use of FFP2 masks in a group of Italian HCWs, with particular emphasis on discerning
Safety 2023,9, 40 4 of 16
variations based on the workers’ roles and individual characteristics. In particular, dis-
comfort and physical disturbance related to prolonged and continuous use of face filter
masks, particularly FFP2 masks, were investigated in a sample of doctors, nurses and
nursing aides, considering also the possible effects of age, BMI and time of use. The study
intended to highlight critical issues which would benefit from re-design interventions
of FFP2 or guidelines for their correct use, to respect human variability while assuring
safety and comfort, in light of the ongoing and, perhaps, re-emerging pandemic and future
similar situations.
2. Materials and Methods
2.1. Participants
Participants were recruited through a snowball procedure, starting from authors’ prior
personal or professional contacts in the population of interest and then sharing an online
questionnaire via social media in different hospitals in northern Italy during January 2022.
Inclusion criteria were being a doctor, nurse or nursing aide and continuous FFP2 use
during work shifts. This resulted in a sample of 156 HCWs.
2.2. Instruments and Procedure
An ad hoc questionnaire was developed for the present investigation, based on previ-
ous instruments and scales. The instrument consisted of 31 questions (28 closed and 3 open
answers), divided into 6 different sections. Only the 4 sections and variables of interest for
the aims of the present paper are described hereafter.
Section 1: Participants’ socio-demographic characteristics. In the first section, partic-
ipants’ socio-demographic data, including gender, age, body mass (kg), height (m) and
professional role (doctor, nurse, nursing aide), were collected;
Section 2: Perceived workload and issues in FFP2 use. In the second section, based
on Van Kampen et al. [
44
], Matusiak et al. [
45
] and Peres et al. [
21
], participants were
asked to rate on a 3-point scale (1 = mild, 2 = moderate, 3 = high) the perceived level of
physical workload required for their job and the number of hours of FFP2 use per day (open
question). Using a short open-ended question [
21
], participants were then asked to describe
the positive and negative aspects when using FFP2 masks. Based on Manookian et al. [
35
],
other relevant physical problems related the to the prolonged use of FFP2 mask were
also investigated: aspects related to several respiratory tract symptoms such as suffering
from episodes of dyspnea (0 = no, 1 = yes) and what type of job tasks participants were
performing at that moment (open-ended question), possible issues related to eyeglasses
adoption when wearing FFP2 masks (open-ended question), if the elastic band adjusters
were used (0 = no, 1 = yes) and the reasons why they were used (widen the elastics, tighten
the elastics, other);
Section 3: Perceived discomfort. Based on Suen and colleagues [
46
] and Galea et al. [
47
],
in the third section of the questionnaire, 8 items (5-point rating scale, 1 = very low, 2 = low,
3 = moderate, 4 = high and 5 = very high) investigated participants’ perception of thermal
discomfort (feeling of heat), thermal discomfort (sensation of humidity), pressure on the
face, breathing difficulties, listening difficulties, speaking difficulties, distraction from the
job and facial skin irritation;
Section 4: Perceived physical disturbance. In the fourth and last section, based on
Rosner [
24
], we asked participants to indicate their perceived level of physical disturbance
(0 = none, 1 = mild, 2 = moderate, 3 = severe) at specific points on the head (ears, nose,
under the chin and cheekbones) and freely write any suggestions for FFP2 improvement
(open answer).
The questionnaire was pilot-tested with a group of 8 HCWs prior being used for the
present investigation. Participants gave positive feedback and small changes were made to
the questionnaire to better clarify the items for the addressed sample. The questionnaire
was administered online through Google Forms and the link to access it was sent through
e-mails and social media. Completion required from 5 to 10 min. The questionnaire was
Safety 2023,9, 40 5 of 16
anonymous and the participation was voluntary. No incentives were offered to respondents.
A brief written presentation of the aim of the study preceded the first section of the
questionnaire, in which it was clarified that the study exclusively addressed doctors, nurses
and nursing aides who wore FFP2 masks continuously during working hours. At the end
of this description, there was a request to confirm the availability to participate in the study.
Then, the respondent could move to the first section. The study was approved by the
Bioethics Committee of the University of Turin (Protocol n. 0175984) and it was conducted
in accordance with the Declaration of Helsinki for human studies of the World Medical
Association [48].
2.3. Data Analysis
The descriptive statistics in terms of mean values and frequencies of all variables
investigated were computed. A chi-square test (
χ2
) and a one-way analysis of variance
(ANOVA) were performed to test the possible associations between the different profes-
sional roles and the perceived level of physical workload required by the job and time of
FFP2 usage. Then, the two factors related to the perceived discomfort and physical distur-
bance were calculated with two Exploratory Factor Analyses (EFA) with no rotation. The
factors were then used as the dependent variables in the subsequent analysis. Furthermore,
the BMI variable was calculated from participants’ self-reported data on height and body
mass as (kg)/height (m)
2
. A multivariate analysis of covariance (MANCOVA) was then
performed to test the effects of professional role (factor), age, number of hours of use per
day of FFP2 and BMI (covariates) on perceived discomfort and physical disturbance. Post
hoc pairwise comparison tests were then performed with Bonferroni’s correction. The
analysis was conducted with Statistical Package for Social Science (SPSS) statistical software
version 28 [49].
An interpretative content analysis was used to analyze the open-ended questions.
The responses were carefully read to obtain a general impression and then categorized by
two authors in recurring themes. The analysis was conducted at a general level, taking
into account the manifest content of open-ended responses [
50
,
51
]. Briefly, the open-
ended responses were read, interpreted by two researchers (authors of this article) and
then aggregated into content areas. Because the open-ended responses were intended to
provide data to contour and complement the quantitative data, they are described here in a
cursory manner.
3. Results
3.1. Descriptive Statistics
Section 1: Socio-demographic characteristics. One hundred and fifty-six HCWs took
part in the study. Their main socio-demographic characteristics are represented in Table 1.
Table 1. Participants’ socio-demographic characteristics.
Variables Total Professional Role Age 2BMI 3
Doctor Nurse Nursing Aide
Frequency (%) Frequency (%) Mean (SD) Mean (SD)
Male 129 (18.6) 17 (10.9) 9 (5.8) 3 (1.9) 41.4 (12.9) 24.8 (3.2)
Female 1127 (81.4) 18 (11.5) 85 (54.5) 24 (15.4) 43.6 (11.4) 23.3 (4.2)
Total 156 (100) 35 (22.4) 94 (60.3) 27 (17.3) 43.2 (11.6) 23.6 (4.1)
1
To identify any anthropometrics-related issues, sex is used as a differentiator rather than gender [
52
].
2
One-way
ANOVA test showed no significant differences between the three professional roles (p= 0.957),
3
One-way ANOVA
test showed no significant differences between the three professional roles (p= 0.823).
Section 2: Workload and issues in FFP2 use. Overall, the participants mainly reported
a mild (54.5%) level of physical workload in their job. In detail, doctors, nurses and nursing
aides declared different perceived levels of physical workload, which was mainly moderate
Safety 2023,9, 40 6 of 16
for both doctors and nurses (51.4 % and 58.5%, respectively) and high for the nursing aides
(55.6%). The chi-square test showed a significant positive association between professional
role and perceived physical workload (χ2(4) = 27.075, p= 0.000) (Table 2).
Table 2. Contingency table for professional role and perceived physical workload.
Professional Role
Perceived Physical Workload
Mild (%) Moderate (%) High (%)
doctor 40.0 51.4 8.6
nurse 18.1 58.5 23.4
nursing aide 0 54.5 55.6
Total 19.9 54.5 25.6
With regard to the FFP2 usage time, more than half of the participants (58%) declared
wearing it for 7 or 8 h per day, whereas 28% wore it for more than 8 h and 14% for less than
6 h. ANOVA showed no significant differences in usage time between the three professional
roles (F(2,151) = 1.503, p= 0.226).
When considering the open question regarding the positive aspects related to the use
of FFP2, two main areas of responses emerged, which were labelled as “feeling of protection
and safety” (reported by 69% of the participants) and “feeling of comfort and adherence”
(reported by 19% of the participants). On these aspects, some quotations extracted from
responses clarify the researchers’ interpretation:
“I feel protected, then I can have a better relationship with patients and provide better
care” [#1], “I feel protected from the spread of the virus” [#2], “I feel more protected, it
fit well on my face” [#3], “with this mask I can breathe better [compared with surgical
mask] because it does not stay too much tight to the mouth and the nose” [#4].
Furthermore, the remaining 3% covered some other different aspects:
“It allows you to breathe better than with the surgical mask” [#5], “I smell less pollution
and bad odours” [#6], “Compared to the surgical mask, FFP2 mask mist less the lenses
of the glasses and the high protective glasses “protect against the cold” and “it has long
durability” [#7].
The main negative aspects reported dealt with three main areas or responses, as well
as a general one: difficulty breathing due to heat/humidity (39%), discomfort caused
by elastic bands or the presence of glasses (32%) and generic pain/discomfort (21%).
Here are examples of responses transcribed related to the difficulty in breathing due to
heat/humidity:
“The mask feels muggy when I am in very warm environment for an excessive and
continuous number of hours” [#8], “I have difficulty breathing, my ears hurt and it causes
deep marks on my face” [#9] and “The air condenses and remains wet inside” [#10].
Examples of quotations related to discomfort caused by elastic bands or the presence
of glasses [#11, #12] and related to generic pain/discomfort [#13, #14] are reported next:
“Sometimes discomfort behind the ears, at times fogging of the glasses” [#11], “It hurts
my nose and ears, and makes it harder to breathe” [#12]; “It causes me contact dermatitis
and the elastic bands are sometimes too tight” [#13], “Skin rashes and skin irritation
around the chin and the nose” [#14].
Furthermore, the remaining 3% covered some other different aspects:
“lints cause disturbance in the nose and mouth” [#15], “cause claustrophobia and after
a while it smell” [#16]. Some doctors also reported: “Elastic band bothers the ears and
frequent headache by wearing PPE at the end of the work shift” [#17], and “Some type of
FFP2 masks caused me dizziness and/or headache” [#18].
Safety 2023,9, 40 7 of 16
The presence of moments of dyspnea during the work shift and the type of work
activity being carried out at that time were investigated. Seventy percent of the participants
reported having had at least one episode. Among these, three main areas of responses
emerged: 45% of cases were in routine actions [#19], 39% while climbing stairs, walking or
talking [#20, #21] and 16% in moments of physical exertion and handling of heavy loads
(e.g., patients) [#22, #23]. Example of responses to clarify the researchers’ interpretation are
reported here:
“It usually happens a few hours after I wear it on” [#19], “Walking up and down the
stairs, when rushing to see a patient or when talking to someone for a long time” [#20],
“It happens when I talk and move at the same time” [#21], “When performing a cardiac
message” [#22] and “Carrying heavy objects up on the stairs” [#23].
Regarding the use of glasses, 62% of the participants reported using glasses and only
5% of them declared no difficulty in wearing the mask together with the eyeglasses. The
most frequent negative aspect, for 75% of people with glasses, was the fogging of the lenses
[#24], while others (20%) reported other types of difficulties [#25, #26]:
“the glasses are fogged with the masks because the masks are too big and lift the glasses”
[#24] and “The glasses lift off my nose and distort my visual field” [#25],
. . .
they tend
to slip or move the mask” [#26].
As for the use of elastic band adjusters, 93 operators out of 156 (59.6%) declared that
they used them; the main reasons for use were the need to widen the elastics (53.8%) or,
on the contrary, to tighten the elastics (8.6%) and to relieve ear discomfort (12.9%). The
remaining percentage (24.7%) did not provide any reason.
When considering the open question regarding possible suggestions to improve FFP2
wearability and comfort in use, 25.6% of the participants suggested the adoption of longer
and adjustable elastic bands [#27], 15.4% suggested the adoption of softer fabrics and 5%
suggested the manufacture of masks of different sizes [#28, #29]:
“More comfort for the nose, elastic bands adjustable depending on the head size” [#27],
“It would be useful if more sizes were available, since many people have a smaller or a
larger face” [#28], and “Produce different size models, like Small, Medium, Large, or
Extra-large” [#29].
Section 3: Perceived discomfort. Regarding the level of discomfort perception when
using FFP2 masks, the items that yielded the highest score were thermal discomfort (feeling
of heat) and pressure on the face. In contrast, listening difficulties and distraction from the
job reported the lowest scores. Details are reported in Table 3.
Table 3.
Mean score and standard deviation for the items used to investigate the level of discomfort
perception when using FFP2 masks.
Variable
Perception Level 1
Mean SD Very Low and
Low (%)
From Moderate to
Very High (%)
Thermal discomfort (heat) 2.8 1.0 39.7 60.3
Thermal discomfort (humidity) 3.1 1.1 28.8 71.2
Pressure on the face 2.9 1.1 33.3 66.7
Breathing difficulties 2.8 1.0 37.8 62.2
Listening difficulties 2.3 1.1 54.4 45.6
Speaking difficulties 2.7 1.0 46.7 53.3
Distraction from the job 1.9 1.0 75.6 24.4
Facial skin irritation 2.6 1.2 51.4 48.6
1for readers’ clarity, the results were grouped.
Safety 2023,9, 40 8 of 16
Section 4: Perceived physical disturbance. Regarding the level of physical disturbance
at specific points on the head, ears reported the highest frequency and the highest score,
followed by nose, cheekbones and under the chin. Details are reported in Table 4.
Table 4.
Mean score and standard deviation for the items used to investigate the level of perceived
physical disturbance when using FFP2 masks.
Variable
Perception Level 1
Mean SD None and
Mild (%)
Moderate and
Severe (%)
Perceived disturbance on ears 2.2 0.8 17.9 82.1
Perceived disturbance on nose 1.3 0.9 57 43
Perceived disturbance under the chin 0.8 0.9 78.9 21.1
Perceived disturbance on cheekbones 0.9 0.9 71.2 28.8
1for readers’ clarity, the results were grouped.
3.2. EFA and MANCOVA
The EFA yielded one factor for the perceived discomfort and one factor for the physical
disturbance, which cumulatively explained 47.31% and 49.51% of the variance, respectively
(see Table 5).
Table 5. Exploratory factor analysis for the two scales considered in the study.
Items Factor Loadings % Explained Variance Cronbach’s α
Perceived discomfort
Thermal discomfort (heat) 0.699 47.312 0.837
Thermal discomfort (humidity) 0.651
Pressure on the face 0.635
Breathing difficulties 0.768
Listening difficulties 0.659
Speaking difficulties 0.792
Distraction from the job 0.604
Facial skin irritation 0.672
Physical disturbance 49.515 0.660
Perceived disturbance on ears 0.623
Perceived disturbance on nose 0.776
Perceived disturbance under the chin 0.706
Perceived disturbance on cheekbones 0.701
Looking at Table 6, the MANCOVA analysis showed that there were significant main
effects of the professional role on both perceived discomfort (F
(2,147)
= 4.21, p= 0.017) and
physical disturbance (F
(2,147)
= 4.42, p= 0.014), whereas age, number of hours of use per
day of FFP2 and BMI had no significant effects on the dependent variables. Post hoc
pairwise comparison tests with Bonferroni’s correction showed that perceived discomfort
among nursing aides was significantly higher compared to doctors (p= 0.014). No other
significant differences emerged between the three groups. Similarly, physical disturbance
was significantly higher among nursing aides compared to both doctors (p= 0.037) and
nurses (p= 0.016), whereas doctors and nurses did not report significant differences in
physical disturbance (p= 1.000).
Table 6. Results for the multivariate analysis of covariance (MANCOVA).
Source Dependent
Variable df Mean Square F p-Values Observed
Power
Professional role Perceived
discomfort 2 155.935 4.205 0.017 * 0.731
Safety 2023,9, 40 9 of 16
Table 6. Cont.
Source Dependent
Variable df Mean Square F p-Values Observed
Power
Age 1 9.965 0.369 0.605 0.081
Number of hours of use per day of FFP2 1 24.282 0.655 0.420 0.127
BMI 1 14.068 0.379 0.539 0.094
Professional role Physical
disturbance 2 29.555 4.419 0.014 * 0.754
Age 1 10.015 1.498 0.223 0.229
Number of hours of use per day of FFP2 1 0.155 0.023 0.879 0.053
BMI 1 6.159 0.921 0.339 0.159
Note * p< 0.05.
4. Discussion
The main goal of the present study was to investigate the quality in use of FFP masks
in a group of HCWs, while also exploring factors impacting the general discomfort and
physical disturbance when wearing this PPE. Data from the submitted questionnaire
showed that thermal discomfort, problems caused by elastic bands or by wearing glasses
and general physical annoyance were the most prevalent aspects.
Regarding perceived discomfort, thermal discomfort appeared to be a major criticality.
Thirty-nine percent of our participants reported breathing difficulties while wearing the
FFP2 mask, due to humidity and heat. This result is in line with that of Hunt and col-
leagues [
53
], who reported that HCWs experienced symptoms comparable to heat strain in
nearly 40% of the sample (level of heat perception from moderate to extreme). Significant
increases in temperature and humidity attributed to the continuous use of FFP2 masks can
lead to adverse effects on productivity [
54
] and thermal stress is documented in several
other studies among HCWs [
18
,
19
]. However, Scarano et al. [
55
] recorded facial skin tem-
perature in different breathing phases with a thermal imaging camera and showed that
even if the perceived discomfort is greater for FFP2 masks than surgical ones, the facial
skin temperature is lower during the inhalation and expiration phases. To shed further
light on this issue, in a future development of this study, it would be useful to collect both
subjective and objective measurements of breathing pressure inside the mask and perceived
breathing effort.
In regard to the main issues in FFP2 use, we found that the majority of the participants
reported having had at least one episode of dyspnea and, among these, nearly half of the
cases in routine actions. This is reflected in the literature, with dyspnea perception and
breathing difficulties ranging from 36% of health care professionals [
21
] to 60% of intensive
care unit healthcare workers [56].
We found that 53.3% of respondents had problems communicating with patients
and other medical personnel, consistent with previous studies on other health profession-
als [
19
,
20
,
57
]. Considering the pivotal role played by effective communication in safety
performance, this aspect should be further analyzed in future research into emergency
situations and surgical performance [20].
Among the negative aspects reported by our participants, some doctors also reported
headaches related to prolonged use of FFP2 masks. The relationship between prolonged
use of PPE and headaches in HCWs [
58
,
59
] has already been shown in the literature, with
discrepancies about its increase as wear hours rise [
24
,
32
]. This problem should not be
overlooked because headaches can reduce concentration and decrease performance [
60
]
and HCWs themselves judge their professional performance as mildly reduced by the use
of PPE [59].
When considering the perceived physical disturbance in FFP2 usage, our sample most
frequently reported pressure-related, with pain behind the ears (85% between moderate
and severe) reporting considerably higher percentages compared to those found in the
literature (e.g., 25% in [
61
]; 25.3% in [
27
]; 32.1% in [
24
]). Just under half of our sample
Safety 2023,9, 40 10 of 16
complained about moderate or severe disturbance on the nose bridge, while other studies
reported percentages of just over 40% [
24
] and more than 80% [
62
]. About one third of our
subjects reported physical disturbance on the cheek/cheekbones, which is less than what
was found by other studies (e.g., 81.7% [
62
]). These divergent percentages bring into focus
the importance of adapting FFP2 masks to specific face and head regions to increase the
level of comfort of this PPE, considering that previous studies pointed out different levels
and areas of physical disturbance among HCWs from different countries [27,33,35].
With regard to ear and nose trouble, our participants suggested some improvements to
solve the issue, such as having longer/adjustable elastic bands made of softer fabrics. Even
the frequent use of adapters in our sample highlights the need to adjust the elastics to avoid
tension on the ears. In fact, for the nasal bridge, adding a soft thickening in correspondence
with the underwire on top of the nose leads to a decrease in localized pressure. This also
enables the possibility to adapt the mask to different nose shapes, with a curved underwire
to provide a better adherence precisely in the region of the nose and zygomatic bone, areas
where more than 70% of the critical points are found [23].
When worn, accurate adjustment/adaptation to the face is required [
25
], for which,
given the morphometric variability of the face, additional adapters and accessories are
proposed to protect specific parts of the head and face, such as protective ears straps
attached to the mask elastics [
25
,
63
], paper clip or a headband to allow ear straps to rest
on these items instead of the ears or a dressing on the nose bridge [
24
]. In relation to
the specific activities of the various operators, it must be considered that the excessive
sweating generated by exhausting workdays and the adaptation made by the professionals
to improve sealing of the facial region can compromise the shape and adaptation of the
mask to the face, contributing both to tissue damage and safety [64].
Taking more frequent breaks during working shifts has been reported as a precaution-
ary measure and recommendation to avoid physical disturbance during the use of FFP
masks [
19
,
24
,
36
]. However, during pandemic and emergency situations, it may become, in
general, difficult to take frequent breaks and, upon removal, PPE needs to be thrown away.
Then, preventive measures to prevent skin damage, such as the application of hydrocolloid
or foam dressing in the pressure regions, moisturizers and emollients [
25
,
29
,
34
] may be
adopted. However, operators often prefer not to use creams and other products despite
these indications being offered (e.g., 17.7% of the participants in the study by [
27
]), possibly
due to the concern that creams, lotions and dressings may interfere with how tightly the
mask fits, decreasing protection [
24
]. Targeted information campaigns, highlighting the
usefulness and safety in the use of these moisturizers, could be designed to tackle this issue.
Future FFP2 development needs to reflect a more diverse group of users, with particu-
lar attention on females and minority groups [
16
]. International organizations have also
stated a need for models to be manufactured in various sizes, although there is currently
no information on standardized sizes [
65
]. It may be necessary to develop new respirator
sizing systems to respect the morphometric differences existing not only between human
groups, but also due to the effects of changes in the secular trend, as pointed out, for
example, by Zhuang [13].
Regarding the possible determinants of the perception of general discomfort and
physical disturbances, our study showed that both aspects appear to be significantly related
to HCWs’ professional roles, with nursing aides and nurses suffering significantly more
from discomfort compared to doctors and nursing aides reporting significantly higher
physical disturbance compared to both nurses and doctors.
On the one hand, this might be due to the fact that different roles are associated with
different levels of physical workload and different movements and effort, which result
in more heat/sweat, thermal stress and humidity and increased perceived discomfort
(as reported by Hunt [
53
]); on the other hand, they may also have PPE insufficiently
adaptable to their morphometric characteristics and not suitable for the activities they have
to perform in relation to the type of material, as it has been shown for women [
52
] and
many ethnicities [
16
] that they are not adequately considered in the panels of measures
Safety 2023,9, 40 11 of 16
and benchmark tests for this PPE. It has to be acknowledged that, in our study, it was not
possible to investigate the role played by perceived workload since the three professional
roles considered significantly differed with regard to it, with nursing aides reporting a
significantly higher workload. This issue could be addressed in a future development of
the study by selecting groups of doctors, nurses and nursing aides with each reporting
both high and low physical workloads.
Contrary to the existent literature, the time of usage did not report any significant
association either with discomfort or physical disturbance. Several studies [
11
,
25
,
27
]
indicated that the amount of PPE usage hours represents a risk factor concurring in adverse
events onset. However, our data showed no significant impact of time of use in general
discomfort and physical disturbances, in line with [
30
]. Our results may be due to the fact
that the participants filled in the questionnaire at their preferred time (they did not have to
be on duty while answering) and they were asked to rate the average daily amount of time
they wear the mask retrospectively, instead of being asked how many hours they had the
mask on while answering the questionnaire. This was a conscious choice by the researchers,
not to interrupt the workers’ activity in an emergency period, but it may have led to biased
responses which affected the results. In a future development of the study, participants may
be asked to answer questions regarding discomfort and physical disturbance at different
times during their work shift (e.g., mid-shift and at the end of the shift), reporting also the
actual FFP2 wearing hours and the specific tasks they were involved in, to monitor the
relationship between these variables.
Contrary to previous evidence [
26
,
66
], in our study, the BMI did not show a significant
association with reported discomfort and physical disturbance. It should be noted that
in our sample, the BMI did not significantly differ among the three professional roles
considered. This aspect should be further investigated and comprehended by involving a
wider group of doctors and nursing aides, to make groups more comparable. Actually, the
existing literature has reported that the prevalence of obesity among nurses is statistically
significantly higher than among other healthcare professionals [67].
The evidence from the literature and from the present work stimulates future stud-
ies for the improvement of respirators to address, above all, the categories less covered
by the current models of PPE, while also considering gender and ethnicity aspects. Col-
lecting morphometric data of the face and head should use an inclusive approach to the
anthropometric variability in different populations, referring also to technological devices
and solutions (see Swennen et al. [
68
], who used mobile phones for the autonomous 3D
scanning of the face and design of 3D-printed respirators) to implement adaptability and
morphometric correspondence in size. With regard to the identification of the factors that
cause greater disturbance and discomfort depending on the workload, always involving
the most disadvantaged categories in usability [
69
] when performing testing starting from
existing models, in order to redesign by modifying the choices of materials, thicknesses,
shapes and dimensions, is recommended to meet specific needs that depend on the type
of activity to be performed and movement entities. Furthermore, even though the WHO
suggests wearing FFP2, or equivalent, masks for no longer than four hours [
2
], this PPE
is worn for significantly longer. Indeed, according to Choudhury [
56
], the FFP2 mask can
guarantee protective filtering capacity for up to a maximum of 6–8 h. Based on this, it is
relevant that an FFP2 mask does not cause discomfort and disturbances in less time of use.
Furthermore, an appropriate redesign of FFP2 masks can lead to a decrease in the number
of masks changed every day and, consequently, reduce the amount of waste generated from
their use. Thus, a good redesign can have not only a positive impact on users’ performance
and safety but positive effects at economic and environmental levels.
Limitations
Some limitations of the present investigation should be acknowledged. We referred to
a non-probabilistic sampling procedure which limited the generalizability of our results.
Further investigations based on a random sampling will give more generalizable results. In
Safety 2023,9, 40 12 of 16
addition, the time to collect responses was only one month. In future studies, this period
could be extended.
In addition, our participants were mainly females, which did not allow sex-based com-
parisons. These data are, nonetheless, consistent with the fact that the female sex strongly
prevails among nurses in Italy (76.45% of members of professional nurses’ association are
females [70]) and also among healthcare professionals in other countries [21,24,46].
It is also good to investigate such critical issues in a female sample, since, in the
creation of the fit-panel, females are not adequately represented and even fewer females
of different ethnic groups [
71
]. Furthermore, the fit-tests are mainly carried out on male
samples and, for them, it is more frequent to have a better success rate for the qualitative
fit-test [
22
], putting females in a disadvantaged position regarding the comfort in use of
FFP2 masks and not providing them with a wide range of respirators to be able to choose
the one that fits best. Ethnicity has emerged to be second to gender for impacting face size
and shape characteristics [
15
] and minority ethnic groups continue to be under-represented
in the reference fit panel of measurements [16].
5. Conclusions
The present study pointed out several criticalities in the use of FFP2 in a group
of HCWs, highlighting specific needs and complaints for the different roles considered
(nurses, nursing aides and doctors). Both general discomfort and physical disturbance
were reported and claimed for more adjustable masks provided by the participants.
Workload associated with different professional roles was associated with different
levels of discomfort while wearing a FFP2 mask, with nursing aides and nurses suffering
significantly more from discomfort compared to doctors, and nursing aides declaring signif-
icantly higher physical disturbance compared to both nurses and doctors. This can possibly
lead to behavioral non-compliance with safety rules and procedures, whereas properly
fitting respiratory protective equipment is paramount, especially in healthcare practices
in situations of urgency and ongoing pandemic. In preparation for future pandemics, it is
imperative to identify solutions to manage the adverse effects of mask usage.
Having FFP2 masks that are suitable or adaptable not only to the different charac-
teristics of the users but also to their professional workload and that can be worn for a
long time during work activities without causing discomfort or actual injuries, represents
a critical issue which deserves further investigation. This is particularly true with regard
to the categories of nursing aides that most effect discomfort and disturbance during
working activities. The attention should first be for healthcare professionals, but then
more comfortable and safer FFP2 masks for different social environments, transports and
other workplaces are of interest to the whole community, in this and other occasions of
interventions necessary for the protection of the population. This is in line with a design-
for-all approach to safety [
72
], whose main goal is for products to be designed for an
“all-encompassing customer base and for a product to be made so that it can be used by
the widest possible range of people” (p. 507). Then, although a lot of progress in the
filtering performance was made, the comfort of this mask requires further improvement,
considering that the equivalent classes of masks around the world (i.e., N95 and NK95)
present minimal design variation.
Author Contributions:
Conceptualization, M.M.C., L.V., C.S. and F.C.; methodology, M.M.C. and
F.C.; formal analysis, L.V. and C.S.; investigation, M.M.C. and F.C.; data curation, F.C.; writing—
original draft preparation, M.M.C., L.V. and C.S.; writing—review and editing, F.C.; supervision, F.C.;
project administration, M.M.C. and F.C. All authors have read and agreed to the published version of
the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement:
The study was conducted in accordance with the Declaration
of Helsinki and approved by the Bioethics Committee of the University of Turin (protocol code 0175984).
Informed Consent Statement:
Informed consent was obtained from all subjects involved in the study.
Safety 2023,9, 40 13 of 16
Data Availability Statement: Data available from the last authors upon request.
Acknowledgments:
The authors would like to thank the anonymous healthcare professionals who
participated in this survey and Giulia Bisone for her help for collecting the data. The authors would
also like to thank Eugenio de Gregorio for his methodological support in the analysis of the qualitative
data and Tiziana C. Callari for her participation in the event “the European night of researchers”,
held by the University of Torino on 24–25 September 2021, where she collaborated to raise awareness
of the project and the correct use of FFP2 masks among local citizens.
Conflicts of Interest: The authors declare no conflict of interest.
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