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BMC Nursing
Development andpsychometric validation
ofthecomfort scale forinjection
Güzel Nur Yildiz1 , Meltem Şirin Gök2 and Bahar Çiftçi2*
Abstract
Background Patients’ comfort level during the injection procedure affects the quality of care. However, the literature
does not provide a valid, reliable, and specific measurement tool to measure this level.
Objective The present study aimed to develop a valid and reliable measurement tool to determine patients’ comfort
levels during the injection procedure.
Method The study was designed methodologically. The study data were collected at two Hospitals. The sample con-
sisted of 102 patients in the pilot application stage and 186 patients in the main application stage. The study’s data
collection tools were the “Personal Information Form,” “VAS for Comfort,” and the “Comfort Scale for Injection” draft. The
obtained data were used for validity and reliability analyses. Validity analyses involved content validity, Exploratory
Factor Analysis (EFA), Confirmatory Factor Analysis (CFA), and criterion validity. Reliability was assessed using Cron-
bach’s Alpha and split-half tests. Statistical analyses were performed with SPSS 22 and AMOS. EFA used the KMO test
and Bartlett’s Test (KMO = 0.878; p < 0.001), with Varimax rotation, while CFA confirmed the factor structure. Pearson
correlation evaluated criterion validity.
Results The scale consisted of 10 items and two sub-scales: “Comfort during the Injection Procedure” and “Environ-
mental Comfort.” The “VAS for Comfort” and the scale and its sub-scales showed a positive correlation. The Cronbach
Alpha Value of the entire scale was found to be 0.899.
Conclusion The data showed that the “Comfort Scale for Injection” is an adequate, valid, and reliable measurement
tool for determining patients’ comfort level during the injection procedure. Measuring patients’ comfort levels dur-
ing injection at regular intervals is recommended, as new studies are planned to increase injection comfort and adapt
the “Comfort Scale for Injection” for different languages and cultures.
Keywords Injection, Patient comfort, Validity and reliability, Scale development
Introduction
Injection procedures, which are frequently used in clini-
cal practice, have an essential place in the treatment
of diseases and maintenance as basic nursing prac-
tices. Injection procedures, including intramuscular,
subcutaneous, intradermal, and intravenous drug admin-
istrations, involve high risks because they are invasive
procedures and affect the comfort of patients [1]. e
essence of drug administration is to maximize the drug’s
beneficial effects by ensuring patient safety, preventing
complications, and ensuring patient comfort [2].
Although injections are considered simple procedures,
they require much attention. Otherwise, injections may
negatively affect the quality of life and patient comfort
and cause serious complications such as disability and
disease [3]. Failure to inject a drug correctly may result in
complications such as too rapid or too slow response to
*Correspondence:
Bahar Çiftçi
bahar.ciftci@atauni.edu.tr
1 Muş Alparaslan University, Muş, Turkey
2 Atatürk University, Erzurum, Turkey
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Page 2 of 12
Yildizetal. BMC Nursing (2024) 23:903
the drug, nerve injury, local bleeding, tissue necrosis and
sterile abscesses, hematoma, and pain [1]. Factors such
as the pain experienced by patients during the injection
procedure, the position, the environment in which the
injection is performed, the trauma caused by the needle
when entering the tissue, the angle of entry into the tis-
sue not being fixed, the nerve endings of the subcutane-
ous tissue, not choosing the appropriate drug volume, the
speed of delivery to the tissue, excessive muscle tension,
previous experiences of patients, ecchymosis, and hema-
toma may impair the patient’s comfort [4, 5]. For this rea-
son, nurses must take measures to prevent complications
in injection procedures, determine patients’ comfort level
for injection, and increase the comfort of the patient [1].
Increasing patients’ comfort level while applying nurs-
ing interventions is integral to professional nursing care.
In the Comfort eory that Katharine Kolcaba devel-
oped, comfort levels are described at three levels: relief,
relaxation, and superiority, and are discussed in four
dimensions: physical, psycho-spiritual, social-cultural,
and environmental [6, 7]. In nursing practice, comfort
consists of defining the comfort needs of the patient,
family, or society, taking precautions for these needs,
and evaluating the basic comfort levels after the proce-
dure [6]. One expected outcome in nursing practice is
to increase the patient’s comfort in line with appropriate
and realistic goals [7, 8].
Comfort plays a crucial role in improving the quality
of healthcare services. Invasive procedures, especially
injections, significantly affect patient satisfaction and
the quality of care provided. Although injection comfort
is a relevant topic in the literature, there is currently no
specific, valid, and reliable measurement tool for assess-
ing patients’ injection comfort. Existing studies primar-
ily utilize general scales such as the Visual Analog Scale,
which, while useful, may not fully capture all dimensions
of comfort related to injections. erefore, it is neces-
sary to develop a valid and reliable tool that specifically
measures injection-related comfort. Evidence-based
approaches to evaluating patient comfort during nursing
care are essential, as comfort provides vital information
about the quality of care. e evaluation of comfort is
critical for delivering better nursing care.
e General Comfort Scale has been used to assess
patient care quality in various fields [9]. However, the
lack of a specific measurement tool for injection com-
fort creates a significant gap in both national and inter-
national literature. Developing a reliable Comfort Scale
for Injection will contribute to both research and clinical
practice by helping nurses and researchers assess injec-
tion comfort more accurately. Such a scale will also be a
valuable feedback tool for hospitals to enhance service
effectiveness, renew institutional procedures, and better
meet societal demands.
Various methods and techniques are employed to
reduce pain and increase comfort during injection proce-
dure [4, 10, 11]. However, when reviewing the literature,
it was found that injection comfort was measured using
only the Visual Analog Scale in studies evaluating the
effects of manual pressure on pain and comfort in subcu-
taneous injections. It was applied in studies on the effects
of manual pressure in subcutaneous injections [11], self-
injection ability in adolescents with food allergies [12],
acupressure in intramuscular injections [13], and shot-
blocker use in subcutaneous [14], and intramuscular
injections [15]. e General Comfort Scale has been used
to assess patient care quality in various fields [9]. How-
ever, the lack of a specific measurement tool for injection
comfort creates a significant gap in both national and
international literature. Developing a reliable Comfort
Scale for Injection will contribute to both research and
clinical practice by helping nurses and researchers assess
injection comfort more accurately. Such a scale will also
be a valuable feedback tool for hospitals to enhance ser-
vice effectiveness, renew institutional procedures, and
better meet societal demands. In light of this, the present
study aimed to develop a Comfort Scale for Injection and
test its validity and reliability.
Method
Type ofthestudy
is study is classified as a methodological study. Meth-
odological research is conducted to develop, validate, and
assess the reliability of measurement tools. is study
aimed to develop a valid and reliable scale to measure
patients’ comfort during the injection procedure. As a
methodological study, it involves not only data collection
but also the processes of scale development, validity, and
reliability testing.
Location anddate ofthestudy
e study was conducted in the injection rooms of the
emergency departments of two hospitals (i.e., Atatürk
Üniversitesi University Research Hospital and Muş State
Hospital). e study data were collected in Erzurumand
Muş between May and June 2023.
Population andsample ofthestudy
e study population consisted of patients who applied
to the emergency departments and the intramuscu-
lar injection rooms of two state hospitals. Accord-
ing to the literature, the number of samples must
include at least 50 individuals in the pilot application
stage and between 5–tenfold the number of items in
the main application stage in scale development and
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Yildizetal. BMC Nursing (2024) 23:903
adaptation studies [16, 17]. A total of 102 individu-
als were included in the pilot application stage of the
study. e actual implementation stage of the study
included 186 patients. It is recommended that Explora-
tory Factor Analysis and Confirmatory Factor Analysis
be performed in different samples in scale development
studies. For this reason, the study data were collected in
two different hospitals.
Sample size calculation
In this study, the sample size was determined based on
commonly used methods in scale development studies.
Data were collected from 102 participants in the pilot
stage and 186 participants in the main stage. According
to the literature, a sample size of 5–10 times the number
of scale items is considered sufficient for scale develop-
ment and adaptation studies. Since the developed scale
consists of 10 items, a sample size of 186 participants
meets this criterion. Additionally, a sample size of 186
participants was used for both Exploratory Factor Analy-
sis (EFA) and Confirmatory Factor Analysis (CFA). e
adequacy of the sample size was confirmed by the Kai-
ser–Meyer–Olkin (KMO) Test and Bartlett’s Test of
Sphericity (KMO = 0.878, p < 0.001).
Inclusion criteria
1. Suitability of the injection site: Absence of condi-
tions that may affect the injection procedure, such as
scarring, incision, lipodystrophy, or infection at the
injection site.
2. Absence of conditions or medications aecting
perception: Participants should not have any condi-
tions (e.g., pain, fear) or be taking medications that
could influence perceptual responses.
3. No use of analgesics or sedatives: Participants
should not be using centrally or peripherally acting
painkillers or sedative medications.
4. No recent injections at the injection site: No injec-
tions should have been administered to the intended
site within the last two days.
5. Normal body mass index (BMI): Participants should
have a BMI within the normal range (18.5–24.9) and
not be underweight or overweight.
6. Type of medication: A prescription for a single dose
of intramuscular injection.
7. Age requirement: Participants should be 18years or
older.
8. Mental competency: No mental disability should be
present, and participants should have legal responsi-
bility.
Exclusion criteria
1. Recent injection at the intended site: Any injection
given to the intended site within the last two days.
2. Known allergy history: Any known allergy to the
prescribed medication or its equivalents.
3. Presence of a mental disability: Any mental disabil-
ity that could affect participation.
4. Conditions or medications aecting perception:
Presence of conditions (e.g., pain, fear) or use of
medications that could affect perception.
5. Severe injection phobia: Presence of significant and
excessive anxiety symptoms related to injection.
Data collection
e data were collected face to face. e forms were pre-
pared using A4 paper, and the individuals were asked to
fill them in after explanations. e data collection proce-
dure took 10–15min.
Injection procedure operators
In the study, the injection procedures were performed by
several nurses working in the emergency departments
of two different hospitals. is approach was adopted to
reflect real clinical settings, where injections are typically
administered by different healthcare professionals. is
variation ensures the generalizability of the scale across
various practitioners.
Data collection tools
e data of the study were collected with the “Personal
Information Form,” “VAS for Comfort,” and “Comfort
Scale for Injection” draft.
Personal information form
is form provides information on the participants’
gender, age, etc., and consists of items questioning their
characteristics.
VAS forcomfort
It was determined that the Visual Analog Scale (VAS)
was used to determine the comfort level for injection in
the literature [4, 11, 18]. For this reason, VAS was used
as a parallel form in the present study. A measuring tool
with a scoring of “0—Not at all Comfortable” and “10—
Very Comfortable” was used on a 10-cm ruler. After
each injection, individuals were asked to mark the level
of comfort they felt from the injection procedure on a
scale of “0” to “10”. Correlation analysis was performed
between the obtained values, the CSFI, and its sub-scale.
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Yildizetal. BMC Nursing (2024) 23:903
e correlation between VAS scores and scale mean
scores indicates that the criterion validity of the scale is
provided.
Comfort scale forinjection
First stage
An item pool was created to develop the CSFI in the
first stage. Interviews were conducted with four nurses
and six patients to develop the item pool. e literature
on injection comfort was reviewed in detail, and an item
pool of 18 items was created. e created item pool was
sent to 13 specialists (6 Nursing Principles Specialists, 2
Internal Medicine Nursing and Care Specialists, 2 Psy-
chiatric Diseases and Care Specialists, 1 Surgical Diseases
and Care Specialist, and 1 Turkish Language and Litera-
ture Specialist). CVI was calculated according to expert
opinions. e lowest CVI value of the items was found to
be 0.85. For this reason, no items were removed from the
item pool. However, after specialist opinions, five items
were added to the item pool, and the 23-item pool was
ready for the pre-application stage of the CSFI.
Second stage
102 people were reached during the pilot implementation
stage. It was found that the item-total correlation value
of 7 items was below 0.30. For this reason, seven items
were removed from the item pool. It was found that the
item-total correlation values of the 16-item scale ranged
between 0.30 and 0.596. e Cronbach Alpha Value of
16 items was determined to be 0.801. With these values,
it was determined that it was possible to proceed to the
actual application stage with the 16-item form of the
scale [17].
Third stage
e validity and reliability analysis of the CSFI was per-
formed, and it was found that the scale consisted of 10
items and two sub-scales. e Cronbach Alpha Value of
the entire scale was determined to be 0.899. It was deter-
mined that the scale is a valid and reliable measurement
tool. e scale was developed in a 5-point Likert style
(1: I strongly disagree- 5: I completely agree). e scale
score is calculated over the average score of the items.
e lowest score that can be obtained from the scale and
sub-scales. is “1”, and the highest score is “5”. ere is no
reverse item in the scale.
Validity analyses
1. Content Validity: Content validity was ensured based
on expert opinions. e Content Validity Index (CVI)
for each item was calculated to reflect the proportion
of agreement among experts regarding the appropri-
ateness of the items. As the lowest CVI value among
the items was 0.85, no items were removed. Instead,
additional items were included based on expert feed-
back.
2. Construct Validity:
◦ Exploratory Factor Analysis (EFA): EFA was con-
ducted to assess the construct validity of the scale.
e suitability of the data for factor analysis was
evaluated using the KMO test and Bartlett’s Test of
Sphericity (KMO = 0.878; Bartlett’s Test of Sphe-
ricity, p < 0.001). Factors with an eigenvalue greater
than 1 were identified, and the Varimax rotation
method was applied. According to the EFA results,
the scale was grouped under two factors, account-
ing for 66.013% of the total variance. e first fac-
tor consisted of items related to comfort during the
injection (e.g., pain, needle insertion and removal),
while the second factor was associated with environ-
mental comfort (e.g., injection environment, waiting
time).
◦ Conrmatory Factor Analysis (CFA): CFA was
conducted to confirm the two-factor structure
obtained from EFA. e AMOS software was used
for the analysis, and fit indices (e.g., CFI, RMSEA)
were considered. e obtained fit indices fell within
the recommended ranges in the literature, indicating
a good model fit.
3. Criterion Validity: Criterion validity was assessed by
performing a correlation analysis between the CSFI
and the Visual Analog Scale (VAS) using the paral-
lel form method. A positive correlation between the
CSFI and its subscales with the VAS indicated that
the criterion validity of the scale was established.
Reliability analyses
1. Internal Consistency (Cronbach’s Alpha): Cron-
bach’s Alpha was calculated to determine the inter-
nal consistency of the scale. e Cronbach’s Alpha
value for the "Comfort during the Injection" subscale
was 0.887, while it was 0.836 for the "Environmental
Comfort" subscale. e total Cronbach’s Alpha for
the entire scale was 0.889, indicating that the scale is
highly reliable.
2. Split-Half Reliability: e split-half reliability of the
scale was analyzed. e Cronbach’s Alpha values for
the first and second halves of the scale were 0.828
and 0.866, respectively. ese results demonstrate a
high level of reliability for the scale.
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Yildizetal. BMC Nursing (2024) 23:903
3. Distinctiveness: e difference in mean scores
between the lower 27% and upper 27% groups was
evaluated using an independent t-test to assess the
distinctiveness of the scale. e significant difference
obtained indicates that the scale has sufficient inter-
nal consistency.
Statistical analysis
e data were analyzed by using the SPSS 22 package
program and the AMOS package program. Also, Arith-
metic mean, standard deviation, percentile, min–max
values, KMO (Kaiser–Meyer–Olkin), Bartlett’s Test of
Sphericity, Anti-Image Values, Factor Analysis, Scree
Plot Graph, Pearson Correlation Coefficient, Cronbach
α, Split-Half Reliability Coefficient Analyzes and Lower
and Upper Quartile Discrimination Analyses were used
to evaluate the data.
Ethical considerations andpermissions
Ethics Committee Approval was obtained from Muş
Alparslan University Scientific Research and Publica-
tion Ethics Committee with decision number 90232 on
18.04.2023. e necessary institutional permission was
obtained from Atatürk University and Muş Provincial
Health Directorate to implement the study. Information
about the purpose and method of the study was given
during the face-to-face interviews. e patients who par-
ticipated in the study were informed that it was based on
the principle of being voluntary. Informed consent form
for participation was obtained from all participants in the
study. It was also explained that the names and data of
the individuals who participated in the study would not
be shared.
Results
e study’s findings, which aimed to develop a valid and
reliable measurement tool to determine patients’ comfort
level during the injection procedure, are given below.
It was found that 58.6% of the individuals who partici-
pated in the study were women, 38% were 41years old
and over, 33.3% had a bachelor’s degree, and 63.4% had a
moderate income. It was also found that 44.5% of the par-
ticipants responded to the “VAS for Injection Comfort”
between 9–10 points (Table1).
Findings regardingvalidity
Exploratory factor analysis
Before the factor analysis, the suitability of the items for
analysis was evaluated. Firstly, the normality distributions
of the items, Cronbach Alpha values, KMO, and Bar-
tlett’s Sphericity Test results were examined, and it was
found that the data obtained from 186 people were usu-
ally distributed (Skewness = −0.527, Kurtosis = −0.224)
(Table2).
When the total correlation values of the items were
examined, it was found that the total correlation value of
1 item (i16) was below 0.30. is item was not included
in the factor analysis because it needed a sufficient
Table 1 Distribution of participants according to
sociodemographic characteristics (N = 186)
Characteristics Variables N %
Gender Female 109 58.6
Male 77 41.4
Age (min–max = 18–80)
(Mean-SD = 34.77–14.28) 18–25 67 36
26–40 67 36
41 and above 52 38
Educational status Primary School 51 27.4
Secondary School 20 10.8
High School 32 17.2
Undergraduate 62 33.3
Post-graduate 21 11.3
Socioeconomic level Good 42 22.6
Moderate 118 63.4
Poor 26 14
VAS for Comfort (Min–
Max = 1–10) (Mean-
SD = 7.88–2.04)
1–5 22 11.8
6–8 81 43.6
9–10 83 44.5
Table 2 The mean, standard deviation, total correlation of the
items and Cronbach α values (if the item is deleted)
Mean Standard
deviation Total
correlation of
the items
Cronbach α values
(if the item is
deleted)
i1 3.92 .921 .634 .889
i2 4.03 .885 .690 .888
i3 4.04 .875 .696 .887
i4 3.82 1.034 .584 .891
i5 3.97 .997 .654 .888
i6 4.16 .867 .604 .890
i7 3.74 .953 .673 .888
i8 3.72 .940 .681 .888
i9 3.91 .902 .690 .887
i10 3.77 .966 .678 .888
i11 3.68 .932 .674 .888
i12 3.80 .940 .641 .889
i13 3.76 .907 .661 .888
i14 3.82 .906 .665 .888
i15 3.85 1.011 .551 .892
i16 2.45 1.243 -.321 .929
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Yildizetal. BMC Nursing (2024) 23:903
item-total correlation value. e item correlation value
of the remaining 15 items varied between 0.551 and
0.696 (Table2). e Cronbach Alpha Value of 15 items
was determined to be 0.929. It was determined that the
test results of the KMO Test, Bartlett Sphericity Test,
and the Lowest Anti-Image Correlation Value were suf-
ficient (KMO = 0.907; Bartlett’s Sphericity Test = 0.001;
Anti-Image Correlation = 0.851–0.948). ese findings
showed that the dataset was suitable for analysis. e
Varimax Axis Rotation, preferred in scale development
studies, was performed to ensure construct validity, and
five items were excluded from the analysis because they
were overlapping items (i7, i8, i10, i13, and i15). e
KMO Test, Bartlett’s Sphericity Test, and Anti-Image
Correlation Values of 10 items were found to be suffi-
cient (KMO = 0.878; Bartlett’s Sphericity Test = 0.001;
Anti-Image Correlation = 0.827–0.918). e results of the
Exploratory Factor Analysis with ten items are given in
Table3.
e Varimax rotation method was employed to maxi-
mize the variance of squared loadings in the factor
matrix, thereby enhancing the interpretability of the
factor structure. is approach was chosen because it
ensures that each item loads highly on only one fac-
tor and minimally on others, clarifying the distinction
between the factors and making the structure easier to
interpret. As a result of the Varimax analysis, the scale
items were grouped under two factors. e decision to
select two factors was based on the presence of two com-
ponents with an eigenvalue above 1, which indicated a
two-factor structure. Although the Scree Plot graph sug-
gested that a three-factor solution could potentially be
considered, the two-factor structure was chosen because
it provided a more interpretable and theoretically
consistent model. is solution aligned well with the con-
ceptual framework, where the factors were labeled "Com-
fort during the Injection Procedure" and "Environmental
Comfort," collectively explaining 66.013% of the total
variance. After the Varimax rotation, all items had factor
loadings above 0.30, supporting the validity of the two-
factor structure (Fig.1, Table3).
When the analysis results were examined, it was found
that the 1st factor consisted of 6 items (including items
1–6) and explained 52.947% of the total variance. is
factor consists of items associated with the position taken
during the injection, opening the injection site, pain felt
when entering and removing the needle from the body,
and cotton-pressing. ese items were named “Com-
fort during the Injection Procedure” because they were
associated with comfort during the Injection Procedure
(Table3).
It was also found that the second factor consisted of 4
items (Items 9, 11, 12, and 14) and explained 13.065% of
the total variance. is factor included waiting time after
injection, injection stretcher, injection environment, and
site selection. is factor was named “Environmental
Comfort” because the items were associated with envi-
ronmental factors.
When the 10-item scale was examined as a whole, it
was found to have a 2-factor structure, which explained
66.013% of the total variance (Table3). It can be argued
that the scale explained sufficient variance. e values
obtained showed that the scale was enough to determine
the comfort levels of individuals during the injection
procedure.
Table 3 CSFI EFA results
Common Factor Variance Factors
1 2
i5. It did not hurt me when the injector was removed 0.737 .841
i4. It did not hurt when the injector went into my body 0.684 .820
i6. Pressing cotton after the Injection Procedure did not disturb me 0.569 .717
i2. I was able to open the injection site easily 0.671 .714
i1. My position was comfortable during the injection 0.622 .706
i3. The injection site was comfortable in terms of privacy 0.672 .664
i12. The injection environment was comfortable in terms of privacy 0.759 .854
i11. The injection stretcher was comfortable 0.677 .797
i9. The post-injection waiting time did not disturb me 0.649 .749
i14. My comfort was taken into account when choosing the injection site 0.562 .697
Eigenvalue ( Total = 6.602) 5.295 1.307
Explained variance ( Total = 66.013%) 52.947 13.065
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Yildizetal. BMC Nursing (2024) 23:903
Conrmatory factor analysis
CFA was tested with the structure obtained by EFA.
CFA was made by using the AMOS Package Program.
Two suitable modification suggestions were found
in the AMOS Package Program. Information on the
fit indices obtained as a result of the CFA is given in
Table 4. The concordance values were evaluated by
considering the literature data [19, 20].
In the analysis made from CFA, it was determined
that seven items in the 2nd factor had standard solu-
tions varying between 0.69–0.81, and the six items in
the 1st factor were between 0.55–0.86 (Fig.2). It was
found that the items were necessary for the factors in
which they were included. The Path Diagram was ana-
lyzed, and the values obtained were suitable for item-
factor agreement (Fig.2).
Findings regardingreliability
Internal consistency (Cronbach Alpha) coecients
Cronbach Alpha Coefficient was calculated to determine
the reliability of the scale. It was found that the Cronbach
Alpha value of the factor “Comfort during the Injection
Procedure” (F1) was 0.887, the Cronbach Alpha value of
the factor “Environmental Comfort” (F2) was 0.836, and
the total Cronbach Alpha value of the scale was 0.889.
ese values show that the scale is quite reliable [16, 21].
Split‑half reliability coecient
As a result of the Split-Half Reliability analysis of the final
version of the scale consisting of 10 items, it was deter-
mined that the Spearman-Brown Correlation Value was
r = 0.815 and the Guttmann Split-Half Coefficient Value
was r = 0.814 and had sufficient values. It was also deter-
mined that the Cronbach Alpha Value of the first part of
the scale was 0.828, and the Cronbach Alpha Value of the
second part of the scale was 0.866. e Split-Half Reli-
ability Analysis results show that the scale is reliable [17].
Determining thedistinctiveness ofthescale
e difference between the mean scores of the lower
27% and upper 27% groups was tested using the t-test
in independent groups to determine the distinctiveness
of the scale and its sub-scales. e significant difference
Fig. 1 Scree plot factor structure
Table 4 CFA goodness of fit indices and normal values
Fit indices Excellent Acceptable Result
χ2 “p” Değeri p > 0.05 - 0.001
χ2/sd (CMIN/DF) < 2 < 5 2.097
CFI > 0.95 > 0.90 0.967
RMSEA < 0.05 < 0.08 0.077
RMR < 0.05 < 0.08 0.042
SRMR < 0.05 < 0.08 0.0499
NFI > 0.95 > 0.80 0.940
TLI 0.95 < TLI < 1 0.90 < TLI < 0.94 0.952
IFI > 0.90 - 0.968
PGFI > 0.89 > 0.50 0.528
PNFI > 0.89 > 0.50 0.647
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Yildizetal. BMC Nursing (2024) 23:903
between the groups due to the analysis indicates the test’s
internal consistency. e t-test results of the differences
between the item average scores of the lower-27% and
upper-27% groups regarding the CSFI and sub-scales are
given in independent groups in Table5. A statistically
significant difference was detected between the mean
scores of the lower-27% and upper-27% groups in terms
of CSFI and sub-scales (p < 0.05). It shows that this scale
is sufficient for distinctiveness (Table5).
The relationship betweenVAS, CSFI andsub‑scales
forcomfort
In scale development studies, another reliability method
is the correlation between the parallel form and the
scale and sub-scales. “VAS for Comfort” was used as the
parallel form in the study. e results of the correlation
analysis of “VAS for Comfort” with CSFI and sub-scales
are given in Table6. It was found that the scale and all
sub-scales showed a positive correlation. It was also
found that the “VAS for Comfort” and the scale and sub-
scales showed a positive correlation. ese findings indi-
cate that the scale is reliable.
Discussion
is study successfully developed and validated the
Comfort Scale for Injection (CSFI), a tool specifically
designed to assess patient comfort during injection pro-
cedures. e CSFI consists of 10 items grouped into two
subscales: "Comfort during the Injection Procedure" and
"Environmental Comfort." Exploratory Factor Analysis
(EFA) revealed a two-factor structure explaining 66% of
the total variance, while Confirmatory Factor Analysis
(CFA) demonstrated good model fit indices, confirming
the construct validity of the scale. e scale showed high
reliability, with a Cronbach Alpha value of 0.899 for the
entire scale, 0.887 for the "Comfort during the Injection
Procedure" subscale, and 0.836 for the "Environmental
Comfort" subscale. Criterion validity was established
through a positive correlation between the CSFI and the
Visual Analog Scale (VAS), indicating concurrent valid-
ity. Discriminant validity analyses showed that the CSFI
could effectively differentiate between patients with high
Fig. 2 Comfort scale confirmatory factor analysis diagram for injection
Table 5 Determination of the discrimination power of CSFI and
sub-dimensions
1st quarter
Mean ± SD 2nd quarter
Mean ± SD t p
Comfort during the Injec-
tion Procedure (F1) 2.23 ± 0.43 3.03 ± 0.27 −14.440 .001
Environmental Comfort
(F2) 3.30 ± 0.64 4.30 ± 0.48 −12.147 .001
Comfort Scale for Injection 3.37 ± 0.48 4.45 ± 0.29 −18.665 .001
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 9 of 12
Yildizetal. BMC Nursing (2024) 23:903
and low levels of injection comfort. ese findings indi-
cate that the CSFI is a valid, reliable, and multidimen-
sional tool for measuring injection-related comfort in
clinical settings.
e findings align with previous research on nurs-
ing interventions and comfort theory. While the Visual
Analog Scale (VAS) is commonly used for measuring
comfort in injection procedures, it primarily provides
a unidimensional assessment, typically limited to the
intensity of comfort or discomfort. e VAS lacks the
ability to capture the multifaceted nature of comfort as
described in Kolcaba’s Comfort eory, which includes
physical, psycho-spiritual, socio-cultural, and environ-
mental dimensions. e Comfort Scale for Injection
(CSFI), on the other hand, was specifically designed
to encompass these multiple dimensions, providing
a more comprehensive assessment of a patient’s com-
fort during the injection procedure. is integration of
Kolcaba’s theoretical framework into the development
of the CSFI represents a significant step toward opera-
tionalizing nursing theories in clinical practice.
Moreover, the development of the CSFI was moti-
vated by the need for a scale that could reliably measure
not just the overall level of comfort but also differenti-
ate between specific factors influencing comfort, such
as environmental aspects and the procedure itself. e
CSFI’s subscales ("Comfort during the Injection Proce-
dure" and "Environmental Comfort") allow for a more
nuanced understanding, enabling targeted interven-
tions to improve patient care. e positive correlation
between the CSFI and the VAS supports the concurrent
validity of the new scale, while the additional psycho-
metric analyses confirm its multidimensional struc-
ture and reliability. us, the CSFI addresses a gap in
the literature by providing a more detailed and spe-
cific tool for evaluating injection-related comfort com-
pared to existing measures like the VAS. By addressing
procedural and environmental dimensions, the CSFI
aligns with previous research that emphasizes the need
for multidimensional tools to capture patient experi-
ences effectively.
e study’s findings, which aimed to develop a valid
and reliable measurement tool to determine patients’
comfort levels during the injection procedure, were dis-
cussed in light of the literature data. In the literature, it
is possible to find studies conducted on comfort during
injection procedures [11, 12, 18]. When these studies
were reviewed, it was seen that a 5-point Likert Scor-
ing or Visual Analog Scale was used to determine the
comfort levels of patients during injection [11, 12, 18].
Increasing the comfort of individuals in nursing practices
is defined as a nursing initiative. For this reason, nurses
are expected to take measures to improve the patient’s
comfort level in nursing practices such as injection pro-
cedures [1]. For this reason, it is essential to support
studies that will increase patients’ comfort levels during
the injection procedure and to develop or adapt a spe-
cific, valid, and reliable measurement tool to measure the
comfort levels during the injection procedure. e CSFI
offers a practical solution by providing a validated tool
for assessing comfort, which can be incorporated into
clinical care protocols and future research. e results of
this study demonstrated that the Comfort Scale for Injec-
tion (CSFI) successfully identified distinct dimensions
of comfort during injection. Specifically, the two-factor
structure revealed in the Exploratory Factor Analysis
indicated that "Comfort during the Injection Procedure"
and "Environmental Comfort" are key aspects influencing
the overall comfort experience of patients. ese dimen-
sions are consistent with the holistic view of comfort in
nursing, where physical and environmental factors both
play crucial roles. e findings suggest that addressing
both procedural and environmental factors can lead to
Table 6 Mean scores of CSFI and sub-dimensions, minimum and maximum scores and correlation analysis results
a Correlation is signicant at the 0.01 level (2-tailed)
Mean ± SD (min–max) VAS for Comfort Comfort during the
Injection Procedure Environmental
Comfort Comfort
Scale for
Injection
VAS for Comfort 7.88 ± 2.40
(1–10) r 1
p
Comfort during the Injection
Procedure 2.65 ± 0.53
(1.33–3.50) r .599a1
p.000
Environmental Comfort 3.80 ± 0.75
(1.50–5.00) r .521a.541a1
p.000 .000
Comfort Scale for Injection 3.92 ± 0.67
(2.00–5.00) r .659a.874a.846a1
p.000 .000 .000
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Page 10 of 12
Yildizetal. BMC Nursing (2024) 23:903
a significant improvement in patient outcomes during
injections.
e measurement tools that can measure the comfort
level during injection were searched in the literature by
using the keywords “Injection,” “Comfort,” and “Dis-
comfort.” In this search, it was found that the “Multidi-
mensional Fear of Injection Scale” [22], “Hep-C Virus
Injection Risk Information Scale” [23], “Blood-Injection
Fear Scale” [24], “Injection Experience Satisfaction Ques-
tionnaire in Patients with Multiple Sclerosis” [25], “irst
Discomfort Scale” [26], “Intravenous or Intradermal
Hemophilia Injection Satisfaction Questionnaire” [27],
and “Prenatal Comfort Scale” [28] were used in these
studies. ese measurement tools were examined in
terms of subject, sub-scales, and items, and it was deter-
mined that they were not similar to the “Comfort Scale
for Injection.” is shows that there is no similar scale
in the national and international literature and that the
scale is unique in this field. e uniqueness of the CSFI
highlights its contribution to nursing and healthcare by
addressing a previously unmet need for a comprehensive
injection comfort measurement tool. Unlike these tools,
the CSFI incorporates multiple dimensions of comfort,
making it the first validated scale to assess this aspect
holistically.
A measurement tool must be valid and reliable to
qualify as a scale [17, 29]. Methods such as construct
validity, content validity, and criterion validity are used
to ensure the validity of a scale. e Exploratory Factor
Analysis and Confirmatory Factor Analysis were used
to ensure the scale’s construct validity in the present
study [17]. It was determined in the Exploratory Fac-
tor Analysis that the CSFI consisted of 2 factors and ten
items and had a 2-factor structure with an eigenvalue
above 1, which explained 66% of the total variance. e
higher the variance rates, the stronger the scale’s factor
structure. e analysis considers it sufficient if the per-
centage of factor loadings explaining the total variance
is 40% and above [17, 20]. e explained variance of 66%
significantly exceeds the commonly accepted threshold
of 40%, emphasizing the CSFI’s robust factor structure
and its ability to comprehensively assess the dimensions
of comfort. e factors were named “Comfort during
the Injection Procedure” and “Environmental Comfort.”
ese dimensions align with Kolcaba’s Comfort eory,
which highlights the importance of both procedural and
environmental aspects in achieving optimal comfort lev-
els in nursing care. In the Confirmatory Factor Analy-
sis, fit indices were examined, and the values obtained
confirmed the construct validity of the scale [19]. e
consistency between the findings from the Explora-
tory and Confirmatory Factor Analyses further rein-
forces the robustness of the scale’s factor structure. e
high explained variance (66%) indicates that the scale
captures a significant portion of the factors influenc-
ing injection comfort. is percentage is notably higher
than the minimum 40% threshold commonly accepted in
scale development studies, suggesting that the CSFI pro-
vides a comprehensive assessment of comfort. Moreover,
the two-factor model aligns with the theoretical under-
standing of comfort in nursing literature, where patient
experiences are shaped by both direct procedural factors
and the surrounding environment. e scale’s criterion
validity was evaluated using the Parallel Forms Method
[17]. VAS for Comfort was used in the Parallel Forms
Method. A positive correlation was detected between
VAS and Comfort Scale for Injection and its sub-scales.
ese values showed that the criterion validity of the
scale was provided [17]. While the Visual Analog Scale
(VAS) provides a unidimensional measure of comfort,
the CSFI’s multidimensional approach enables a deeper
understanding of patient experiences during injections,
addressing both procedural and environmental fac-
tors simultaneously. e significant positive correlation
between the CSFI and the VAS supports the concurrent
validity of the scale, indicating that the CSFI is effective
in capturing patients’ perceived comfort levels. is find-
ing is crucial, as it confirms that the new scale not only
complements existing tools like the VAS but also extends
beyond them by providing a multidimensional approach
to understanding comfort during injections.
A Cronbach Alpha value of 0.70 and above indicates
that a scale is reliable [16, 17]. e Cronbach Alpha value
of “Comfort during the Injection Procedure” was found
to be 0.887, and the Cronbach Alpha value of “Envi-
ronmental Comfort” was 0.836. e Cronbach Alpha
value for the entire scale was determined to be 0.889.
e literature states that a Cronbach’s Alpha Coefficient
between 0.60–0.80 is sufficient for a measurement tool to
be used in research. ese values show that the scale is
quite reliable [16, 21, 30]. ese findings align with the
reliability benchmarks established in the psychometric
literature, demonstrating that the CSFI meets the criteria
required for a robust clinical and research tool. e Split-
Half Reliability analysis determined that the Cronbach
Alpha value of the first part of the scale was 0.828, and
the Cronbach Alpha value of the second part of the scale
was 0.866. e results of the Split-Half Reliability analy-
sis show that the scale is highly reliable [17]. is level
of reliability not only meets but exceeds the thresholds
reported in similar studies, such as those evaluating tools
like the Visual Analog Scale (VAS) [21]. By surpassing
these standards, the CSFI provides a more comprehen-
sive and multidimensional assessment of patient comfort.
In the discriminant validity of the scale, the difference
between the 27% lower and upper group mean scores
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 11 of 12
Yildizetal. BMC Nursing (2024) 23:903
regarding the scale’s sub-scales and the total score was
found to be statistically significant. is result shows that
the scale distinguishes patients with high injection com-
fort and patients with low injection comfort. Addition-
ally, the discriminant validity results confirm the scale’s
unique ability to differentiate between varying levels of
comfort, addressing a critical gap in existing comfort
measurement tools, which often lack this specificity. e
high reliability coefficients and significant discriminant
validity results further establish the scale’s reliability and
its ability to differentiate between varying levels of com-
fort during injections. ese findings are consistent with
established standards for scale development, indicating
that the CSFI is a robust tool for clinical and research
applications. All findings show that the Comfort Scale for
Injection is a valid and reliable measurement tool.
Limitations ofthestudy
is study has certain limitations that should be acknowl-
edged. Firstly, the sample was limited to two hospitals
and a specific demographic group, which may restrict
the generalizability of the findings. Future studies with
larger and more diverse populations are recommended
to validate the scale further. Secondly, the study relied on
self-reported data, which could introduce response bias.
Although efforts were made to ensure honest and accu-
rate responses, this limitation should be considered when
interpreting the results.
Conclusion andrecommendations
Injection procedures can be disturbing because of rea-
sons such as pain, position, injection environment, pri-
vacy, hygiene practices, and post-injection complications.
For this reason, some studies are conducted on comfort
during injection procedures in the literature. However,
it was determined that the “Visual Analogue Scale” was
used to evaluate comfort in these studies. In this study,
a valid and reliable measurement tool was developed to
assess comfort during injection. e Comfort Scale for
Injection consists of 10 items and two sub-scales. It was
found that the Cronbach Alpha Value of the “Comfort
for the Injection Procedure” sub-scale was 0.887, the
Cronbach Alpha Value of the “Environmental Comfort”
sub-scale was 0.836, and the Cronbach Alpha value of
the entire scale was 0.899. e scale was developed in a
5-point Likert style as “1- strongly disagree” and “5—I
completely agree”. ere is no reverse item in the scale.
ese findings show that the “Comfort Scale for Injec-
tion” is a valid and reliable measurement tool for measur-
ing the comfort levels of individuals during the injection
procedure. In future studies, it is recommended to use
the “Comfort Scale for Injection” to determine com-
fort levels during injection, and to conduct new studies
that will examine the comfort levels of individuals dur-
ing injection. Future research should focus on testing the
Comfort Scale for Injection (CSFI) in different cultural
contexts to validate its cross-cultural applicability. Addi-
tionally, adapting the scale for other types of injections,
such as subcutaneous or intravenous injections, would
broaden its usability in clinical practice. ese steps
will help enhance the scale’s reliability and utility across
diverse settings, contributing to improved patient care
globally.
Acknowledgements
We thank the patient for taking part in the study.
Authors’ contributions
1. Study design: B.Ç., G.N.Y, M.Ş.G. 2. Data collection: B.Ç., 3. Data analysis: G.N.A,
M.Ş.G. 4. Study supervision: B.Ç., G.N.Y, M.Ş.G. 5.Manuscript writing: B.Ç., G.N.Y.
6. Critical revisions for important intellectual content: B.Ç., G.N.Y.
Funding
The author(s) received no financial support for the research, authorship, and/
or publication of this article.
Data availability
Datasets used and/or analyzed during the current study are available from the
corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
The study was approved by the Scientific Research and Publication Ethics
Committee of Muş Alparslan University on 18.04.2023, with decision number
90232. Written informed consent was obtained from all participants after they
were provided with detailed information about the purpose and process of
the study.
Consent for publication
Not applicable. This manuscript does not include identifying images or per-
sonal or clinical details of participants that compromise anonymity.
Competing interests
The authors declare no competing interests.
Received: 17 August 2024 Accepted: 29 November 2024
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