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 consisted 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 Cronbach'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 “Environmental 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 during 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.
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Introduction
Injection procedures, which are frequently used in clinical practice, have an essential place in the treatment of diseases and maintenance as basic nursing practices. Injection procedures, including intramuscular, subcutaneous, intradermal, and intravenous drug administrations, involve high risks because they are invasive procedures and affect the comfort of patients [1]. The 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 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 tissue not being fixed, the nerve endings of the subcutaneous tissue, not choosing the appropriate drug volume, the speed of delivery to the tissue, excessive muscle tension, previous experiences of patients, ecchymosis, and hematoma may impair the patient’s comfort [4, 5]. For this reason, nurses must take measures to prevent complications in injection procedures, determine patients’ comfort level for injection, and increase the comfort of the patient [1].
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Increasing patients’ comfort level while applying nursing interventions is integral to professional nursing care. In the Comfort Theory that Katharine Kolcaba developed, 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 procedure [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 assessing patients’ injection comfort. Existing studies primarily utilize general scales such as the Visual Analog Scale, which, while useful, may not fully capture all dimensions of comfort related to injections. Therefore, it is necessary 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. The evaluation of comfort is critical for delivering better nursing care.
The 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 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 service effectiveness, renew institutional procedures, and better meet societal demands.
Various methods and techniques are employed to reduce pain and increase comfort during injection procedure [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 subcutaneous 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]. The 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 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 service 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.
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Method
Type of the study
This study is classified as a methodological study. Methodological research is conducted to develop, validate, and assess the reliability of measurement tools. This 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 and date of the study
The 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). The study data were collected in Erzurum and Muş between May and June 2023.
Population and sample of the study
The study population consisted of patients who applied to the emergency departments and the intramuscular injection rooms of two state hospitals. According 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 adaptation studies [16, 17]. A total of 102 individuals were included in the pilot application stage of the study. The actual implementation stage of the study included 186 patients. It is recommended that Exploratory 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 development 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 Analysis (EFA) and Confirmatory Factor Analysis (CFA). The adequacy of the sample size was confirmed by the Kaiser–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 conditions that may affect the injection procedure, such as scarring, incision, lipodystrophy, or infection at the injection site.
2.
Absence of conditions or medications affecting perception: Participants should not have any conditions (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 injections 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 18 years or older.
8.
Mental competency: No mental disability should be present, and participants should have legal responsibility.
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 disability that could affect participation.
4.
Conditions or medications affecting 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
The data were collected face to face. The forms were prepared using A4 paper, and the individuals were asked to fill them in after explanations. The data collection procedure took 10–15 min.
Injection procedure operators
In the study, the injection procedures were performed by several nurses working in the emergency departments of two different hospitals. This approach was adopted to reflect real clinical settings, where injections are typically administered by different healthcare professionals. This variation ensures the generalizability of the scale across various practitioners.
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Data collection tools
The data of the study were collected with the “Personal Information Form,” “VAS for Comfort,” and “Comfort Scale for Injection” draft.
Personal information form
This form provides information on the participants’ gender, age, etc., and consists of items questioning their characteristics.
VAS for comfort
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. The correlation between VAS scores and scale mean scores indicates that the criterion validity of the scale is provided.
Comfort scale for injection
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. The literature on injection comfort was reviewed in detail, and an item pool of 18 items was created. The created item pool was sent to 13 specialists (6 Nursing Principles Specialists, 2 Internal Medicine Nursing and Care Specialists, 2 Psychiatric Diseases and Care Specialists, 1 Surgical Diseases and Care Specialist, and 1 Turkish Language and Literature Specialist). CVI was calculated according to expert opinions. The 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. The 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
The validity and reliability analysis of the CSFI was performed, and it was found that the scale consisted of 10 items and two sub-scales. The Cronbach Alpha Value of the entire scale was determined to be 0.899. It was determined that the scale is a valid and reliable measurement tool. The scale was developed in a 5-point Likert style (1: I strongly disagree- 5: I completely agree). The scale score is calculated over the average score of the items. The lowest score that can be obtained from the scale and sub-scales. is “1”, and the highest score is “5”. There is no reverse item in the scale.
Validity analyses
1.
Content Validity: Content validity was ensured based on expert opinions. The Content Validity Index (CVI) for each item was calculated to reflect the proportion of agreement among experts regarding the appropriateness 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 feedback.
2.
Construct Validity:
◦ Exploratory Factor Analysis (EFA): EFA was conducted to assess the construct validity of the scale. The 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 Sphericity, 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, accounting for 66.013% of the total variance. The first factor consisted of items related to comfort during the injection (e.g., pain, needle insertion and removal), while the second factor was associated with environmental comfort (e.g., injection environment, waiting time).
◦ Confirmatory Factor Analysis (CFA): CFA was conducted to confirm the two-factor structure obtained from EFA. The AMOS software was used for the analysis, and fit indices (e.g., CFI, RMSEA) were considered. The 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 parallel 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): Cronbach's Alpha was calculated to determine the internal consistency of the scale. The Cronbach's Alpha value for the "Comfort during the Injection" subscale was 0.887, while it was 0.836 for the "Environmental Comfort" subscale. The total Cronbach's Alpha for the entire scale was 0.889, indicating that the scale is highly reliable.
2.
Split-Half Reliability: The split-half reliability of the scale was analyzed. The Cronbach's Alpha values for the first and second halves of the scale were 0.828 and 0.866, respectively. These results demonstrate a high level of reliability for the scale.
3.
Distinctiveness: The 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. The significant difference obtained indicates that the scale has sufficient internal consistency.
Statistical analysis
The data were analyzed by using the SPSS 22 package program and the AMOS package program. Also, Arithmetic 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.
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Ethical considerations and permissions
Ethics Committee Approval was obtained from Muş Alparslan University Scientific Research and Publication Ethics Committee with decision number 90232 on 18.04.2023. The 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. The patients who participated 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
The 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 participated in the study were women, 38% were 41 years 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 participants responded to the “VAS for Injection Comfort” between 9–10 points (Table 1).
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
Findings regarding validity
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 Bartlett’s Sphericity Test results were examined, and it was found that the data obtained from 186 people were usually distributed (Skewness = −0.527, Kurtosis = −0.224) (Table 2).
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
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. This item was not included in the factor analysis because it needed a sufficient item-total correlation value. The item correlation value of the remaining 15 items varied between 0.551 and 0.696 (Table 2). The 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 sufficient (KMO = 0.907; Bartlett’s Sphericity Test = 0.001; Anti-Image Correlation = 0.851–0.948). These findings showed that the dataset was suitable for analysis. The 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). The KMO Test, Bartlett’s Sphericity Test, and Anti-Image Correlation Values of 10 items were found to be sufficient (KMO = 0.878; Bartlett’s Sphericity Test = 0.001; Anti-Image Correlation = 0.827–0.918). The results of the Exploratory Factor Analysis with ten items are given in Table 3.
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
The Varimax rotation method was employed to maximize the variance of squared loadings in the factor matrix, thereby enhancing the interpretability of the factor structure. This approach was chosen because it ensures that each item loads highly on only one factor 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. The decision to select two factors was based on the presence of two components with an eigenvalue above 1, which indicated a two-factor structure. Although the Scree Plot graph suggested 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. This solution aligned well with the conceptual framework, where the factors were labeled "Comfort 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, Table 3).
Fig. 1
Scree plot factor structure
×
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. This 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. These items were named “Comfort during the Injection Procedure” because they were associated with comfort during the Injection Procedure (Table 3).
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. This factor included waiting time after injection, injection stretcher, injection environment, and site selection. This factor was named “Environmental Comfort” because the items were associated with environmental 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 (Table 3). It can be argued that the scale explained sufficient variance. The values obtained showed that the scale was enough to determine the comfort levels of individuals during the injection procedure.
Confirmatory 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].
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
In the analysis made from CFA, it was determined that seven items in the 2nd factor had standard solutions 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 analyzed, and the values obtained were suitable for item-factor agreement (Fig. 2).
Fig. 2
Comfort scale confirmatory factor analysis diagram for injection
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. These values show that the scale is quite reliable [16, 21].
Split-half reliability coefficient
As a result of the Split-Half Reliability analysis of the final version of the scale consisting of 10 items, it was determined 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 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. The Split-Half Reliability Analysis results show that the scale is reliable [17].
Determining the distinctiveness of the scale
The 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. The significant difference between the groups due to the analysis indicates the test’s internal consistency. The 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 Table 5. 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 (Table 5).
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 Injection 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
The relationship between VAS, CSFI and sub-scales for comfort
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. The results of the correlation analysis of “VAS for Comfort” with CSFI and sub-scales are given in Table 6. 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. These findings indicate that the scale is reliable.
Table 6
Mean scores of CSFI and sub-dimensions, minimum and maximum scores and correlation analysis results
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
.599a
1
p
.000
Environmental Comfort
3.80 ± 0.75
(1.50–5.00)
r
.521a
.541a
1
p
.000
.000
Comfort Scale for Injection
3.92 ± 0.67
(2.00–5.00)
r
.659a
.874a
.846a
1
p
.000
.000
.000
aCorrelation is significant at the 0.01 level (2-tailed)
Discussion
This study successfully developed and validated the Comfort Scale for Injection (CSFI), a tool specifically designed to assess patient comfort during injection procedures. The 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. The 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 validity. Discriminant validity analyses showed that the CSFI could effectively differentiate between patients with high and low levels of injection comfort. These findings indicate that the CSFI is a valid, reliable, and multidimensional tool for measuring injection-related comfort in clinical settings.
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The findings align with previous research on nursing 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. The VAS lacks the ability to capture the multifaceted nature of comfort as described in Kolcaba's Comfort Theory, which includes physical, psycho-spiritual, socio-cultural, and environmental dimensions. The 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 comfort during the injection procedure. This integration of Kolcaba's theoretical framework into the development of the CSFI represents a significant step toward operationalizing nursing theories in clinical practice.
Moreover, the development of the CSFI was motivated by the need for a scale that could reliably measure not just the overall level of comfort but also differentiate between specific factors influencing comfort, such as environmental aspects and the procedure itself. The CSFI's subscales ("Comfort during the Injection Procedure" and "Environmental Comfort") allow for a more nuanced understanding, enabling targeted interventions to improve patient care. The positive correlation between the CSFI and the VAS supports the concurrent validity of the new scale, while the additional psychometric analyses confirm its multidimensional structure and reliability. Thus, the CSFI addresses a gap in the literature by providing a more detailed and specific tool for evaluating injection-related comfort compared 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 experiences effectively.
The study’s findings, which aimed to develop a valid and reliable measurement tool to determine patients’ comfort levels during the injection procedure, were discussed 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 Scoring 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 procedures [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 specific, valid, and reliable measurement tool to measure the comfort levels during the injection procedure. The CSFI offers a practical solution by providing a validated tool for assessing comfort, which can be incorporated into clinical care protocols and future research. The results of this study demonstrated that the Comfort Scale for Injection (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. These dimensions are consistent with the holistic view of comfort in nursing, where physical and environmental factors both play crucial roles. The findings suggest that addressing both procedural and environmental factors can lead to a significant improvement in patient outcomes during injections.
The measurement tools that can measure the comfort level during injection were searched in the literature by using the keywords “Injection,” “Comfort,” and “Discomfort.” In this search, it was found that the “Multidimensional Fear of Injection Scale” [22], “Hep-C Virus Injection Risk Information Scale” [23], “Blood-Injection Fear Scale” [24], “Injection Experience Satisfaction Questionnaire in Patients with Multiple Sclerosis” [25], “Thirst Discomfort Scale” [26], “Intravenous or Intradermal Hemophilia Injection Satisfaction Questionnaire” [27], and “Prenatal Comfort Scale” [28] were used in these studies. These measurement tools were examined in terms of subject, sub-scales, and items, and it was determined that they were not similar to the “Comfort Scale for Injection.” This shows that there is no similar scale in the national and international literature and that the scale is unique in this field. The 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. The 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 Factor 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. The higher the variance rates, the stronger the scale’s factor structure. The analysis considers it sufficient if the percentage of factor loadings explaining the total variance is 40% and above [17, 20]. The 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. The factors were named “Comfort during the Injection Procedure” and “Environmental Comfort.” These dimensions align with Kolcaba’s Comfort Theory, which highlights the importance of both procedural and environmental aspects in achieving optimal comfort levels in nursing care. In the Confirmatory Factor Analysis, fit indices were examined, and the values obtained confirmed the construct validity of the scale [19]. The consistency between the findings from the Exploratory and Confirmatory Factor Analyses further reinforces the robustness of the scale’s factor structure. The high explained variance (66%) indicates that the scale captures a significant portion of the factors influencing injection comfort. This percentage is notably higher than the minimum 40% threshold commonly accepted in scale development studies, suggesting that the CSFI provides a comprehensive assessment of comfort. Moreover, the two-factor model aligns with the theoretical understanding of comfort in nursing literature, where patient experiences are shaped by both direct procedural factors and the surrounding environment. The 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. These 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 factors simultaneously. The 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. This finding 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]. The Cronbach Alpha value of “Comfort during the Injection Procedure” was found to be 0.887, and the Cronbach Alpha value of “Environmental Comfort” was 0.836. The Cronbach Alpha value for the entire scale was determined to be 0.889. The literature states that a Cronbach’s Alpha Coefficient between 0.60–0.80 is sufficient for a measurement tool to be used in research. These values show that the scale is quite reliable [16, 21, 30]. These 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. The 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. The results of the Split-Half Reliability analysis show that the scale is highly reliable [17]. This 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 comprehensive and multidimensional assessment of patient comfort. In the discriminant validity of the scale, the difference between the 27% lower and upper group mean scores regarding the scale’s sub-scales and the total score was found to be statistically significant. This result shows that the scale distinguishes patients with high injection comfort and patients with low injection comfort. Additionally, 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. The high reliability coefficients and significant discriminant validity results further establish the scale’s reliability and its ability to differentiate between varying levels of comfort during injections. These 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 of the study
This study has certain limitations that should be acknowledged. 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 accurate responses, this limitation should be considered when interpreting the results.
Conclusion and recommendations
Injection procedures can be disturbing because of reasons such as pain, position, injection environment, privacy, 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. The 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. The scale was developed in a 5-point Likert style as “1- strongly disagree” and “5—I completely agree”. There is no reverse item in the scale. These findings show that the “Comfort Scale for Injection” is a valid and reliable measurement tool for measuring the comfort levels of individuals during the injection procedure. In future studies, it is recommended to use the “Comfort Scale for Injection” to determine comfort levels during injection, and to conduct new studies that will examine the comfort levels of individuals during injection. Future research should focus on testing the Comfort Scale for Injection (CSFI) in different cultural contexts to validate its cross-cultural applicability. Additionally, adapting the scale for other types of injections, such as subcutaneous or intravenous injections, would broaden its usability in clinical practice. These 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.
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 personal or clinical details of participants that compromise anonymity.
Competing interests
The authors declare no competing interests.
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