Development of Comfort Scale for Injection

doi:10.21203/rs.3.rs-4931215/v1

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Research Article

Development of Comfort Scale for Injection

https://doi.org/10.21203/rs.3.rs-4931215/v1

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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 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.

Results

The scale consisted of 10 items and two sub-dimensions: “Comfort during the Injection Procedure” and “Environmental Comfort.” The “VAS for Comfort” and the scale and its sub-dimensions 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.

Clinical trial number:

not applicable.

Injection

Comfort

Scale

Validity

Reliability

Scale development

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 (Potter et al., 2013). The essence of drug administration is to maximize the drug’s beneficial effects by ensuring patient safety, preventing complications, and ensuring patient comfort. (Karadağ et al., 2023).

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 (Taylan Filinte et al., 2010). 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 (Potter et al., 2013). 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 (Karabey & Karagözoğlu, 2021a; Zijlstra et al., 2018). 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 (Potter et al., 2013).

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 (Kolcaba, 1994; Krinsky et al., 2014). 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 (Kolcaba, 1994). One expected outcome in nursing practice is to increase the patient's comfort in line with appropriate and realistic goals (Kolcaba et al., 2006; Krinsky et al., 2014).

Various methods and techniques are employed to reduce pain and increase comfort during injection procedure (Farnia et al., 2017; Karabey & Karagözoğlu, 2021a, 2021b). When the literature was reviewed, it was found that only the Visual Analog Scale was used when evaluating comfort for injection in a study examining the effects of manual pressure on pain and comfort level in subcutaneous injection (Karabey & Karagözoğlu, 2021b), in a study to increase the ability of self-injection of epinephrine in adolescents with food allergy (Shemesh et al., 2017), in a study examining the effects of acupressure on intramuscular injection pain and satisfaction (Inangil & Inangil, 2020), in a study evaluating the effect of shot-blocker use on pain severity and injection satisfaction in subcutaneous injection procedures (Coşkun, 2019), and in a study comparing the effects of manual pressure and shot-blocker on pain and satisfaction in intramuscular injection (Kaplan et al., 2023). Although injection comfort is a current issue in the literature, it was determined that there is no measurement tool to measure the injection comfort of patients. However, it is recommended to use evidence-based approaches to measure patient comfort in the implementation and evaluation of nursing care. Comfort provides information about the quality of care. Evaluation of comfort is essential in terms of delivering better nursing care. The effectiveness of patient care in various fields is evaluated with the General Comfort Scale (Kuğuoğlu & Karabacak, 2008). However, the absence of a valid, reliable, and specific measurement tool to determine injection comfort creates a gap in the national and international literature. Having a valid and reliable Comfort Scale for Injection will contribute to researchers’ and clinician nurses’ determination of injection comfort and the conduct of new interventional studies. The Comfort Scale for Injection will be an essential feedback tool in providing an effective and efficient service in hospitals, renewing the institutions' procedures, and responding to society's demands by determining patients’ injection comfort levels. Also, patient satisfaction and comfort have become essential and priority parameters for daily assessing the quality of healthcare services. In light of this information, the purpose of the present study was to develop the Comfort Scale for Injection and test its validity and reliability.

Type of the study

The study was conducted methodologically.

Location and date of the study

The study was conducted in the injection rooms of the emergency departments of two hospitals (i.e., X University Research Hospital and X State Hospital). The study data were collected in Erzurum 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 5-10-fold the number of items in the main application stage in scale development and adaptation studies (Pallant, 2020; Seçer, 2020). 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.

Inclusion criteria of the study

- Absence of conditions that may affect injection procedures, such as scarring, incision, lipodystrophy, and infection at the injection site
- Absence of diseases that may affect perception, such as pain and fear, or not using drugs that may cause these
- Not using centrally or peripherally acting analgesics or sedatives
- No injection in the area to be injected in the last two days
- Not being underweight or overweight
- Ordering the drug that requires one dose of intramuscular injection
- Being 18 years old and over
- Not having a mental disability and having a criminal responsibility

Exclusion criteria of the study

- Having an injection to the injection site in the last two days
- Having a history of allergy to the ordered drug or its equivalents
- Having a mental disability
- Having a disease or drug use that may affect pain, fear, or perception
- Having advanced injection phobia

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 minutes.

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 (Karabey, 2020; Karabey & Karagözoğlu, 2021a, 2021b). 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-dimensions. 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 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 (Seçer, 2020).

Third stage: The validity and reliability analysis of the EBQI was performed, and it was found that the scale consisted of 10 items and two sub-dimensions. 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-dimensions is “1”, and the highest score is “5”. There is no reverse item in the scale.

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.

Ethical Considerations and Permissions

Ethics Committee Approval was obtained from XX University Scientific Research and Publication Ethics Committee with decision number X on X. The necessary institutional permission was obtained from X University and X 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, and their consent was obtained. It was also explained that the names and data of the individuals who participated in the study would not be shared.

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
Gender	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

1. 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)
	Ortalama	SD	Madde Toplam Korelasyon Değeri	Madde Silinirse Cronbach Alpha Değeri
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
	Common Factor Variance	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

As a result of the Varimax Analysis, it was found that the scale items were grouped under two factors. The presence of 2 components with an eigenvalue above 1 indicated that the scale had a 2-factor structure. All items' Factor loadings were above 0.30 after the Varimax Rotation Method. Also, the Scree Plots Graph indicated that the scale has a 2-factor structure (Fig. 1) (Table 3).

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.

2. 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 (Aksu et al., 2017; Bae, 2017).

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).

Findings Regarding Reliability

1. Internal Consistency (Cronbach Alpha) Coefficients

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 (DeVellis, 2016; Pallant, 2020).

2. 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 (Seçer, 2020).

3. 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-dimensions. 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-dimensions 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-dimensions (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

4. The Relationship Between VAS, CSFI, and Sub-Dimensions for Comfort

In scale development studies, another reliability method is the correlation between the parallel form and the scale and sub-dimensions. “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-dimensions are given in Table 6. It was found that the scale and all sub-dimensions showed a positive correlation. It was also found that the “VAS for Comfort” and the scale and sub-dimensions 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
VAS for Comfort	7.88 ± 2.40 (1–10)	p
Comfort during the Injection Procedure	2.65 ± 0.53 (1.33–3.50)	r	.599^**	1
Comfort during the Injection Procedure	2.65 ± 0.53 (1.33–3.50)	p	.000
Environmental Comfort	3.80 ± 0.75 (1.50-5.00)	r	.521^**	.541^**	1
Environmental Comfort	3.80 ± 0.75 (1.50-5.00)	p	.000	.000
Comfort Scale for Injection	3.92 ± 0.67 (2.00–5.00)	r	.659^**	.874^**	.846^**	1
Comfort Scale for Injection	3.92 ± 0.67 (2.00–5.00)	p	.000	.000	.000
**. Correlation is significant at the 0.01 level (2-tailed).

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 (Karabey, 2020; Karabey & Karagözoğlu, 2021b; Shemesh et al., 2017). 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 (Karabey, 2020; Karabey & Karagözoğlu, 2021b; Shemesh et al., 2017). 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. (Potter et al., 2013) 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 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” (Hako et al., 2022), “Hep-C Virus Injection Risk Information Scale” (Quinn et al., 2019), “Blood-Injection Fear Scale” (Kose & Mandiracioglu, 2007), “Injection Experience Satisfaction Questionnaire in Patients with Multiple Sclerosis” (Buck et al., 2012), “Thirst Discomfort Scale” (Çiftçi et al., 2023), “Intravenous or Intradermal Hemophilia Injection Satisfaction Questionnaire” (Kempton et al., 2021), and “Prenatal Comfort Scale” (Şenol et al., 2021) were used in these studies. These measurement tools were examined in terms of subject, sub-dimensions, 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.

A measurement tool must be valid and reliable to qualify as a scale (Seçer, 2020; Tavşancıl, 2018). 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 (Seçer, 2020). 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 (Aksu et al., 2017; Seçer, 2020). The factors were named “Comfort during the Injection Procedure” and “Environmental Comfort.” In the Confirmatory Factor Analysis, fit indices were examined, and the values obtained confirmed the construct validity of the scale (Bae, 2017). The scale’s criterion validity was evaluated using the Parallel Forms Method (Seçer, 2020). 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-dimensions. These values showed that the criterion validity of the scale was provided (Seçer, 2020).

A Cronbach Alpha value of 0.70 and above indicates that a scale is reliable (Pallant, 2020; Seçer, 2020). 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 (DeVellis, 2016; Pallant, 2020). 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 (Seçer, 2020)(16). In the discriminant validity of the scale, the difference between the 27% lower and upper group mean scores regarding the scale’s sub-dimensions 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. All findings show that the Comfort Scale for Injection is a valid and reliable measurement tool.

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-dimensions. It was found that the Cronbach Alpha Value of the “Comfort for the Injection Procedure” sub-dimension was 0.887, the Cronbach Alpha Value of the “Environmental Comfort” sub-dimension 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, to conduct validity and reliability analyses in other countries and cultures, and to conduct new studies that will examine the comfort levels of individuals during injection.

Availability of data and materials

Datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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,

Acknowledgements

We thank the patient for taking part in the study.

Ethical Approval

Ethics Committee Approval was obtained from Muş Alparslan University Scientific Research and Publication Ethics Committee with decision number 90232 on 18.04.2023

Autobiographical Notes

Assistant Professor Bahar Çiftçi,

Bahar Çiftçi is a lecturer at Atatürk University Faculty of Nursing, Department of Nursing Principles. She graduated from tatürk University Nursing Faculty in 2010. After graduation, she worked as a newborn, child and emergency nurse. She has been working as a research assistant at Atatürk University Faculty of Nursing between 2013-218 and as an assistant professor in the Department of Nursing Principles since 2018. She received his master's degree in 2013 and his doctorate in 2018.

She teaches "basic nursing", "nursing models", "health assessment and physical examination", "nursing ethics", "nursing process", "technology in nursing", "rational drug practices", "Nursing values". She also teaches postgraduate (master's) courses in the Department of Principles of Nursing. She is the author and co-author of articles, books, and other publications on the basics of nursing, and has led legal research projects. She is a member of the Turkish Nurses Association.

Aksu G, Eser MT, Güzeller CO. Structural equation model applications with exploratory and confirmatory factor analysis. Detay Publishing; 2017.
Bae B-R. Structural equation modeling with Amos 24. Chenngram Books; 2017.
Buck P, Conner J, Mathena J, Castelli-Haley J, Denney D. PND43 Development of the Satisfaction with Injection Experience Questionnaire for Patients with Multiple Sclerosis. Value Health. 2012;15(4):A149. https://doi.org/https://doi.org/10.1016/j.jval.2012.03.802.
Coşkun Y. (2019). The Effect of Shotblocker Use on Subcutaneous Injection Applications in Adult Patients on Pain Intensity and Injection Satisfaction [Master Thesis, Erciyes University]. Kayseri.
Çiftçi B, Yıldız GN, Avşar G, Köse S, Aydın E, Doğan S, Çelik Ş. (2023). Development of the Thirst Discomfort Scale: A Validity and Reliability Study. American journal of critical care: an official publication, American Association of Critical-Care Nurses, 32(3), 176–183. https://doi.org/https://doi.org/10.4037/ajcc2023954
DeVellis RF. Scale development: Theory and applications. Volume 26. Sage; 2016.
Farnia F, Zeighamian S, Dehghani K, Lotfi H. Comparison of EMLA cream and cold on the injection site pain in enoxaparin. Community Health J. 2017;8(2):39–46.
Hako S, Kambara K, Ogata A. The development and validation of the multidimensional fear-of-injection scale. Health Psychol Behav Med. 2022;10(1):806–17. https://doi.org/10.1080/21642850.2022.2116328.
Inangil D, Inangil G. The effect of acupressure (GB30) on intramuscular injection pain and satisfaction: Single–blind, randomised controlled study. J Clin Nurs. 2020;29(7–8):1094–101. https://doi.org/https://doi.org/10.1111/jocn.15172.
Kaplan A, Güler S, Avşaroğulları ÖL. Comparison of manual pressure and shotblocker on pain and satisfaction ın intramuscular injectıon: a randomızed controlled trial. Sağlık Bilimleri Dergisi. 2023;32(1):89–96. https://doi.org/https://doi.org/10.34108/eujhs.1123965.
Karabey T. (2020). Comparison of the effect of internal rotation of the extremities on intramuscular injection, local cold application and the use of shotblocker on injection pain and comfort level Sivas Cumhuriyet Uniivetsity]. Sivas.
Karabey T, Karagözoğlu Ş. The Effect of Aspiration During Intramuscular Injection Into the Ventrogluteal Region on the Level of Pain and Comfort Associated with the Injection. Turkiye Klinikleri J Nurs Sci. 2021a;13(2):303–9. https://doi.org/10.5336/nurses.2020-77248.
Karabey T, Karagözoğlu Ş. The effect of manual pressure after subcutaneous injection on pain and comfort levels. J Vasc Nurs. 2021b;39(4):134–9. https://doi.org/https://doi.org/10.1016/j.jvn.2021.09.003.
Karadağ S, Aydinli A, Yilmaz C, Tutar N. Effect of cold application and compression on pain and bruising in subcutaneous heparin injection. J Vasc Nurs. 2023;41(1):22–6. https://doi.org/https://doi.org/10.1016/j.jvn.2023.01.002.
Kempton C, Trask P, Parnes A, Niggli M, Campinha-Bacote A, Callaghan U, Mahlangu M, J. N. Development and testing of the Satisfaction Questionnaire with Intravenous or Subcutaneous Hemophilia Injection and results from the Phase 3 HAVEN 3 study of emicizumab prophylaxis in persons with haemophilia A without FVIII inhibitors. Haemophilia. 2021;27(2):221–8. https://doi.org/https://doi.org/10.1111/hae.14222.
Kolcaba K, Tilton C, Drouin C. Comfort theory: a unifying framework to enhance the practice environment. JONA: J Nurs Adm. 2006;36(11):538–44.
Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994;19(6):1178–84. https://doi.org/https://doi.org/10.1111/j.1365-2648.1994.tb01202.x.
Kose S, Mandiracioglu A. Fear of blood/injection in healthy and unhealthy adults admitted to a teaching hospital. Int J Clin Pract. 2007;61(3):453–7. https://doi.org/https://doi.org/10.1111/j.1742-1241.2006.01150.x.
Krinsky R, Murillo I, Johnson J. A practical application of Katharine Kolcaba's comfort theory to cardiac patients. Appl Nurs Res. 2014;27(2):147–50. https://doi.org/https://doi.org/10.1016/j.apnr.2014.02.004.
Kuğuoğlu S, Karabacak Ü. Turkish Version of the General Comfort Questionaire. Florence Nightingale J Nurs. 2008;16(61):16–23.
Pallant J. (2020). SPSS survival manual: A step by step guide to data analysis using IBM SPSS (3 ed.). McGraw-hill education (UK).
Potter PA, Perry AG, Stockert PA, Hall AM. (2013). Fundamentals of Nursing Elsevıer Mosby.
Quinn K, Fong C, Guarino H, Mateu-Gelabert P. Development, validation, and potential applications of the hepatitis C virus injection-risk knowledge scale (HCV-IRKS) among young opioid users in New York City. Drug Alcohol Depend. 2019;194:453–9. https://doi.org/https://doi.org/10.1016/j.drugalcdep.2018.11.010.
Seçer İ. Psychological test development and adaptation process: SPSS and LISREL applications. Anı yayıncılık; 2020.
Shemesh E, D'Urso C, Knight C, Rubes M, Picerno KM, Posillico AM, Sicherer SH. Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection. J Allergy Clin Immunology-in Pract. 2017;5(2):391–. https://doi.org/10.1016/j.jaip.2016.12.016.
Şenol DK, Özkan SA, Aslan E. Adaptation of the Prenatal Comfort Scale into Turkish: A Validity and Reliability Study. Florence Nightingale J Nurs. 2021;29(2):221. https://doi.org/https://doi.org/10.5152%2FFNJN.2021.20051.
Tavşancıl E. Measuring attitudes and data analysis with SPSS. Volume 6. Nobel Academic Publishing; 2018.
Taylan Filinte G, Akan M, Filinte D, Gönüllü ME, Aköz T. Gluteal injections: As harmless as we think? Case report. Kartal Train Res Hosp Med J. 2010;21(2):89–93.
Zijlstra E, Jahnke J, Fischer A, Kapitza C, Forst T. Impact of injection speed, volume, and site on pain sensation. J Diabetes Sci Technol. 2018;12(1):163–8. https://doi.org/https://doi.org/10.1177/1932296817735121.

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Development of Comfort Scale for Injection

Status:

Version 1

Abstract

Background

Objective

Method

Results

Conclusion

Clinical trial number:

Figures

INTRODUCTION

METHOD

Type of the study

Location and date of the study

Population and sample of the study

Data Collection

Data Collection Tools

Comfort Scale for Injection

Statistical Analysis

Ethical Considerations and Permissions

RESULTS

1. Exploratory Factor Analysis

2. Confirmatory Factor Analysis

1. Internal Consistency (Cronbach Alpha) Coefficients

2. Split-Half Reliability Coefficient

3. Determining the Distinctiveness of the Scale

4. The Relationship Between VAS, CSFI, and Sub-Dimensions for Comfort

DISCUSSION

CONCLUSION AND RECOMMENDATIONS

Declarations

References

Additional Declarations

Status:

Version 1