Background
A child’s admission to the pediatric intensive care unit (PICU) is, in most cases, a traumatic process because the PICU is seen as a place of suffering fear, discomfort, and pain [1]. The International Association for the Study of Pain (IASP) defines pain as “an unpleasant sensory and emotional experience associated with actual and potential tissue damage“ [2]. Children in intensive care units experience pain through non-invasive methods such as positioning, dressing changes, and oral care, in addition to invasive procedures such as intravenous and arterial access, suction, or re-intubation [3, 4]. In a study, Barslag et al. stated that patients in the PICU experience an average of 11 painful procedures per day, and in general, analgesics are not prescribed during these procedures [5].
A combination of pain, stress, and separation from parents, along with different voices in the environment and multiple caregivers, may hurt a child’s health [6, 7]. The short-term effect of discomfort and pain may be seen in the form of changes in clinical physiological variables such as heart rate changes, oxygen saturation levels, blood pressure fluctuations, respiratory rate fluctuations, apnea, increased restlessness, and sleep pattern changes [8]. In addition, experiencing constant pain and discomfort during childhood can lead to long-term behavioral complications such as anxiety and fear, mental problems, and reduced IQ, as well as immune system disorders and related diseases [6, 7].
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Analgesia is essential to prevent pain and discomfort in these critically ill pediatric patients. It allows health workers to perform invasive procedures safely, supports synchronization, and provides comfort for patients on mechanical ventilation [9]. The use of these medicines can be very helpful, but their excessive use can increase the need for mechanical ventilation and the length of hospitalization [10, 11]. On the other hand, inadequate pain relief can lead to restlessness and unwanted extubation [9]. The results of a systematic review showed that only 57.6% of pediatric patients were optimally sedated, while 31.8% were overly restless and 10.6% were moderately sedated [4]. Therefore, it is explained that excessive sedation or oversedation of children in the intensive care unit is more than under sedation. Effective pain management using painkillers and relaxation techniques in noncommunicative PICU-admitted patients can only be done using objective assessments with a valid and reliable tool. Some research with an emphasis on pain control in ICU patients indicates that pain is not assessed adequately by caregivers [12, 13]. The results of Kudchadkar et al.‘s study showed that only 42% of nurses in PICUs regularly perform objective pain assessments [14]. To ensure optimal clinical care and treatment in children and adolescents hospitalized in intensive care units, early identification of pain is necessary to prevent its adverse consequences [15, 16]. Therefore, it seems necessary to have a standardized scale for monitoring pain and comfort in critically ill pediatric patients [17‐19].
Although there are different tools for assessing pain in patients, each one is suitable for a specific age range or for patients with the ability to communicate. For example, the McGill pain questionnaire (MPQ) is ideal for adults, and the adolescent pediatric pain tool (APPT) is for children and adolescents between 8 and 17 years of age with the ability to describe the location of pain [20], the neonatal infant pain scale (NIPS) or CRIES scale (crying, requires oxygen, increased vital signs, expression, and sleepless) is used only in the age range under one year, the scale of FLACC (face, leg, activity, cry, consolability) is for children 2 to 7 years old, the numerical rating scale (NRS) scale is for children 8 years or older.
But there is another tool called the Comfort Behavior Scale (CBS) that can be used for children from birth to 18 years hospitalized in intensive care units with or without the ability to communicate due to intubation [13]. The CBS is an instrument first developed in 1992 by Amboel et al. as a non-invasive method to assess distress and pain in mechanically ventilated children in the pediatric intensive care unit, in which eight factors; six behavioral and two physiological factors are evaluated [21].
This tool has been translated and validated in Indonesian, Portuguese, Swedish, Chinese, Norwegian, and Italian [7, 9, 22‐25]. The CBS is more comprehensive compared to other scales and can increase the sensitivity of nurses to the level of sedation and comfort in unconscious children and force the nurse to re-examine after performing palliative measures [9].
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According to clinical observations in Iranian hospitals and a review of available studies, there is no valid scale or tool for objective quantification of comfort level in critically ill pediatric patients. Since the expression of pain is influenced by communication barriers, culture, genetic background, biological factors, gender and race [23, 26], this study was done to translate and validate the Persian version of the CBS so that it can be available to clinical nurses, nursing researchers, and other medical staff.
Methods
This methodological research was carried out to translate and validate the CBS-Persian version from Nov 2023 to Apr 2024. The research environment was intensive care units of children’s hospitals in Tehran province (Iran).
Since no nurse in Iran was familiar with this tool, we had to first teach 10 nurses how to work with the tool So, the inclusion criteria for nurses in this research were having work experience in the PICU for more than 3 months, not completing training courses related to pain management in the last year, the willingness of the nurse to participate in the study, and the exclusion criteria was incomplete completion of the questionnaires.
The inclusion criteria for patients were age less than 18 years, length of stay in the PICU at least 48 h, inability to communicate verbally due to mechanical ventilation or reduced level of consciousness, and exclusion criteria were severe complications after surgery, such as bleeding and hemodynamic disorders, parents’ unwillingness to continue the research and increase the patient’s level of consciousness and the possibility of verbal communication.
The sample size was estimated using G. Power 3.0.10 software and considering the significance level of α < 0.05, test power of 0.8, and effect size of 0.33, 66 patients. However, due to the possibility of attrition, 70 cases were considered [27].
Therefore, during 6 months, 70 patients who met the criteria for entering the study were enrolled in the study by the available method and after completing the informed consent form by their parents or legal guardians, and the CBS was used by nurses.
Translation is a common way to prepare tools for cross-cultural research, which can be fraught with challenges. Therefore, in addition to the ability of translators to achieve the closest fit of content, semantics, and conceptual meaning, there is also a need for the opinions of the society that uses that tool, so that structural and content reforms can be made if necessary, taking into account cultural conditions [28]. Therefore, the process of translating and validating the tool was done in 6 steps.
In the first step, the World Health Organization (WHO) model was used to equate the scale in the Persian language. The translation from English to Persian (Forward) was done by two separate translators. One of them was familiar with the fields related to health and the second one was an expert in English and unfamiliar with the field of medical sciences. After checking the items of the scale by a committee of experts in the field of validation, the scale was translated into English (Backward) by two independent translators who had no prior knowledge of the items of the scale.
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In the second step, to determine the qualitative face validity a face-to-face interview was conducted with ten nurses with clinical experience in the pediatric intensive care unit regarding the level of difficulty, appropriateness, and ambiguity of each item. To determine quantitative face validity, the method of impact score was used. In this way, ten experienced nurses were asked to rate the importance of the items of the scale on a five-point Likert scale from completely important to not important at all, and the impact score of each item was calculated based on the following formula. Obtaining a score higher than 1.5 was the criterion for maintaining the item [29].
$$\:Impact\:Score\hspace{0.17em}=\hspace{0.17em}Frequency\:\times\:\:Importance$$
(1)
In the third step, content validity was done. Content validity refers to whether a scale contains appropriate items for the construct to be measured and adequately covers the domain of the construct [29]. According to Haynes, to determine the quality of content validity, the items should be examined by experts in terms of grammar, use of appropriate words, placement of phrases in the appropriate place, and appropriate scoring [20]. In this research, ten faculty members who had rich knowledge and experience in the field of tool construction and pain research were requested to provide the necessary feedback in writing based on the above criteria. Then content validity was done quantitatively based on Rungtusanatham ‘s theory. In the quantitative evaluation of content validity, two points should be paid attention to, 1- making sure that the most important and correct content is selected (CVR) and 2- the items of the scale are designed in the best way to measure the content (CVI). To calculate the content validity ratio, ten experts in this field were asked to review the items based on the three-part spectrum: it is necessary, it is useful but not necessary, and it is not necessary. Then the answers were calculated based on the following formula [30].
$$CVR = {{nE - {N \over 2}} \over {{N \over 2}}}$$
(2)
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The result obtained after the calculation according to the number of experts was compared with the Laushe table, the minimum numerical value of CVR. In this regard, according to the Laushe table, phrases whose content validity ratio was equal to or greater than 0.62 (based on the evaluation of 10 experts) are retained [30].
To calculate the content validity index of CVI, the researcher gave the questionnaire to 10 experts to rate the relevance of each statement in the questionnaire in a 4-point Likert scale (1- not relevant, 2- somewhat relevant, 3- relevant). 4- It is completely related) to each of the items. Then the score for each item is calculated by dividing the number of experts who agree with the phrase rated 3 and 4 by the total number of experts and the items whose CVI score is higher than 0.79 are kept. According to Polit and Beck’s theory, only the measurement of relevance is sufficient and more important in the evaluation of the CVI [29, 30].
$$CVI\, = \,{{Number\,of\,raters\,giving\,a\,rating\,of\,'3'\,or\,'4'} \over {total\,number\,of\,raters}}$$
(3)
With the same method, the reliability index was calculated for all items and then for the whole tool using the S-CVI/Ave method.
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In the fourth step, the discriminant validity method was used to determine the construct validity [31, 32]. In this way, 10 nurses with more than 3 months of experience in the intensive care unit were selected. During a two-hour theoretical and practical training session at the patient’s bedside, the nurses were trained about the research objectives and how to complete the scale by the main researcher.
In this study, the pain and comfort of each patient were measured once during the morning shift and at a suitable time to avoid the main confounding factors such as hunger, drug administration, and sleep (8 am), and the second time during painful procedures (suctioning or changing position) by a nurse trained with the Persian version of the CBS.
For this purpose, the child’s body movements and facial expressions were monitored for 2 min using an alarm clock, and at the end, the muscle tone was determined by gently touching the arms or legs.
Before observing the patient, the bed sheet is removed so that the nurse can fully observe his face and body. The nurses were taught that in case of any change in the sedative/anesthetic prescription, the CBS should be recalculated within one hour [23].
The increase in patients’ pain during the invasive procedure showed the validity of the scale to assess pain and confirm it. Each trained nurse performed the aforementioned process for 7 patients. In this way, a total of 140 observations were recorded with the CBS-Persian. The scores obtained from evaluation observations during the two stages were analyzed by paired t-test.
In the fifth step, to check the criterion validity, two other scales (Nurse Interpretation of Sedation Score (NISS) and the 11-point numerical rating scale (NRS) were used even though they represent the silver standard because they are based on expert opinion [33, 34].
For this study, the decision to compare the CBS with these two scales that reflect expert opinion was based on their ease of use and the fact that they were used by nurses working in the PICUs involved in the study. The same choice was made by Fagioli et al. (2018) and Boerlage et al. (2015) when validating the CBS [7, 35].
The NISS measures the level of sedation through the attribution of a score based on the nurses’ personal opinion of the sedation depth. The scale has three categories: 1 for insufficient sedation, 2 for adequate sedation, and 3 for over sedation. There is no objective variable based on which nurses should observe and evaluate the patient. The nurses decide about the NISS score based on their experience and clinical competencies [36].
If the COMFORT-B score is 23 or higher, the patient is considered understated or if COMFORT-B scores of 11–22 combined with NISS the patient is considered adequate sedation, and scores less than 11 in COMFORT B are considered oversedation [35].
The 11-point numerical rating scale (NRS) is a global pain rating scale with which the nurse rates pain intensity by number (0–1 for no pain, 1–3 for mild pain, 4–7 for moderate pain, and 8–10 for worst imaginable pain). It is suited both for self-report and proxy reports. NRS scores in this study are proxy scores, referred to as NRSobs scores. An NRSobs score of 4 or higher indicates pain and requires intervention based on pain and sedation protocols. In the COMFORT-B scale, a score of 17 or higher along with a NRSobs score of 4 or higher indicates pain and requires intervention. In case of high COMFORT-B and NRSobs scores for postoperative pain, nurses first use non-pharmacological interventions such as body position change, pacifier, or diaper change. In case of ineffectiveness, systemic analgesics are prescribed in predetermined doses, i.e., morphine for pain and midazolam for discomfort, according to the protocol [35].
Both of these tools were completed simultaneously by two other nurses at the end of each assessment for each patient. The correlation of the obtained results was measured with Pearson’s coefficient. Using experts’ opinions to validate scales is a common method. When the “golden standard” is not available, the expert’s opinion can be considered the “silver standard“ [33].
In the sixth step, weighted kappa was used to determine the reliability. For this purpose, the measurement of pain and comfort in each patient was recorded by the second evaluator during the rest period and the painful procedure. To determine the internal homogeneity of the coefficient, Cronbach’s alpha coefficient was used. The obtained data was analyzed with SPSS22 software.
How to use the scale
CBS offers 6 variables (Alertness, Calmness/Agitation, Respiratory response, Physical movement, Muscle tone, and Facial tension) (Table 1). Physiological variables including heart rate (HR) and arterial pressure (AP) are used to more objectively assess the level of distress used in the original scale. Since these two variables are controlled with medication in the PICU, their utility in evaluating the adequacy of sedation is questionable, so they have been omitted from the CBS. This scale can also be used in children who are not under mechanical ventilation, but the “respiratory response” variable should be removed and the “crying” variable should be used instead [21, 25].
Table 1
COMFORT Behavior Scale and Scoring Form
Date ___________________ Time _______________________Observer ___________________ | ||
|---|---|---|
Alertness | • Deeply asleep (eyes closed, no response to changes in the environment) • Lightly asleep (eyes mostly closed, occasional responses) • Drowsy (child closes his or her eyes frequently, less responsive to the environment) • Awake and alert (child responsive to the environment) • Awake and hyperalert (exaggerated responses to environmental stimuli) | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Calmness–Agitation | • Calm (child appears serene and tranquil) • Slightly anxious (child shows slight anxiety) • Anxious (child appears agitated but remains in control) • Very anxious (child appears very agitated, just able to control) • Panicky (child appears severely distressed, with loss of control) | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Respiratory response (Score only in mechanically ventilated children) | • No spontaneous respiration • Spontaneous and ventilator respiration • Restlessness or resistance to ventilator • Active breathing against the ventilator or regular coughing • Fighting against ventilator | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Crying (Score only in children breathing spontaneously) | • Quiet breathing, no crying sounds • Occasional sobbing or moaning • Whining (monotone) • Crying • Screaming or shrieking | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Physical movement | • No movement • Occasional (3 or fewer) slight movements • Frequent (more than 3) slight movements • Vigorous movements limited to extremities • Vigorous movements including torso and head | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Muscle tone | •Muscles completely relaxed, no muscle tone •Reduced muscle tone, less resistance than normal •Normal muscle tone •Increased muscle tone and flexion of fingers and toes • Extreme muscle rigidity and flexion of fingers and toes | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
Facial tension | • Facial muscles completely relaxed • Normal facial tone • Tension evident in some facial muscles (not sustained) • Tension evident throughout facial muscles (sustained) • Facial muscles contorted and grimacing | ❑ 1 ❑ 2 ❑ 3 ❑ 4 ❑ 5 |
The assessor begins the two-minute observation period from a position where he/she can easily see the patient’s entire body and face, as well as the vital signs monitor. The evaluator makes a quick assessment of movement, body posture, facial expression, response to environmental stimuli, etc., based on a comfort scale. Approximately 10 s before the end of the observation period, the observer assesses muscle tone based on the patient’s response to rapid and slow flexion of a non-instrumented limb (e.g., elbow or knee without an IV, tape, arterial line, or physical restraint). If no other joint is available, the wrist or ankle may be used. The rater walks away from the patient and records the rating for each scale. The most extreme (disturbing) behavior observed during the observation period is scored on each variable. The total comfort score is obtained as the sum of the scores of the six dimensions. In all 6 variables, the items are scored on a Likert scale from 1 to 5. (Alertness: 1 for deep sleep, 2 for light sleep, 3 for drowsiness, 4 for alertness, and 5 for high alertness. Calmness: 1 for complete calmness, higher ratings for increased anxiety and agitation. Respiratory distress: How much your breathing indicates pain, with higher ratings for agitated breathing. Crying: 1 for no crying, higher scores for moaning, sobbing, or screaming. Physical movement: 0 for no movement (a sign of less pain), 1 or 2 for some movement, and higher scores for vigorous movements (e.g., thrashing in pain). Muscle tone: A score of 3 for normal, lower scores for diminished muscle tone, and higher scores for rigid muscles. Facial tension: 1 for a completely normal, relaxed face, and higher ratings for signs of strain). Therefore, the total score varies from 6 to 30. Scores ≥ 17 indicate the need for pain reduction intervention [21, 22].
A score of ≤ 10 corresponds to super sedation and ≥ 23 to low sedation. The average scores [11‐22] were not able to predict the degree of sedation and required more careful observation and simultaneous examination with another tool. This scale is considered a complex scale due to the number of variables in each level [21, 25].
Results
Based on the demographic characteristics of the patients, 43 were boys and 27 were girls. The mean and standard deviation of the age of these children was 4.47 ± 3.5 years. The largest number of children were hospitalized for non-surgical reasons. The consciousness level of the patients was between 4 and 14 according to the Glasgow Coma Scale (GCS). In the group of nurses, the mean ± standard deviation of the age was 39.30 ± 6.7, the range of work experience in the special pediatric department was between 1 and 18 years with an approximate average of 9 years, and 8 of them were women and 2 were men (Table 2).
Table 2
Demographic characteristics of patients and nurses
Variable | Frequency | Percentage (%) | |
|---|---|---|---|
Patients | Age 1 > year 1–3 years 4–6 years 7–12 years > 13 years | 12 24 19 10 5 | 17.1 34.3 27.1 14.3 7.1 |
*M ± SD | 4.47 \(\:\pm\:\) 3.5 | ||
Gender Female Male | 43 27 | 61.4 38.6 | |
Diagnosis Internal Surgery | 42 28 | 60.0 40.0 | |
Nurses | Age 21–30 31–40 41–50 | 2 4 4 | 20 40 40 |
*M ± SD | 39.30\(\:\:\pm\:\:\)6.70 | ||
Gender Female Male | 8 2 | 80 20 | |
Work experience in PICU 3–12 months 2–5 years 6–10 years 11–15 years > 16 years | 1 2 2 4 1 | 10 20 20 40 10 | |
In the qualitative face validity review based on the opinions of the participants, none of the items changed in terms of appropriateness, ambiguity, and usability in Iranian society. In the quantitative evaluation of the face validity of the questionnaire, all 30 items had an impact score of more than 1.5, and as a result, no item was deleted. In terms of qualitative content validity, experts gave brief explanations for all items for better understanding by nurses, and some words were replaced with more concrete words. For example, in the deep sleep variable, an explanation was given as “the child’s eyes are closed and do not react to changes in the environment”.
In checking the CVR, all the experts had marked the necessary option for all the items, considering the minimum value of 0.62 for 10 experts, none of the items were removed. In checking the CVI, all the items scored higher than 0.8, which were recognized and retained according to the acceptable criteria. S-CVI/Ave for the whole scale was evaluated as 0.96 and acceptable (Table 3).
Table 3
CVI of each dimension and S-CVI/Ave of the whole scale
Dimensions | CVI |
|---|---|
Alertness | 0.96 |
Calmness/ Agitation | 1 |
Respiratory response | 0.96 |
Physical movement | 0.92 |
Muscle tone | 1 |
Facial tension | 0.92 |
S-CVI/Ave | 0.96 |
Regarding the discriminant validity, the researcher assumed that the pain score increases during the painful action compared to the resting state, but remains unchanged during the non-painful action, and the results showed that there is a significant difference between the pain score in painful and non-painful situations (Table 4).
Table 4
Average score of pain in patients before and during painful procedures
Variable | Time Before During | **P-value | |
|---|---|---|---|
*M ± SD *M ± SD | |||
Alertness | 3.95\(\:\pm\:0.54\) | 4.64\(\:\pm\:0.81\) | P = 0.000 |
Calmness–Agitation | 3.92\(\:\pm\:0.54\) | 4.70\(\:\pm\:0.77\) | P = 0.000 |
Respiratory response | 4.71\(\:\pm\:0.72\) | 3.14\(\:\pm\:0.50\) | P = 0.000 |
Physical movement | 2.96\(\:\pm\:0.55\) | 3.96\(\:\pm\:0.52\) | P = 0.000 |
Muscle tone | 2.98\(\:\pm\:0.49\) | 3.92\(\:\pm\:0.54\) | P = 0.000 |
Facial tension | 2.42\(\:\pm\:1.02\) | 4.51\(\:\pm\:0.83\) | P = 0.000 |
Total | 20.97\(\:\pm\:2.48\) | 24.87\(\:\pm\:2.55\) | P = 0.000 |
In the evaluation of criterion validity, as the Pearson coefficient correlation results show, there is a positive and significant correlation between the NISS and the CBS, as well as the NRS and the CBS, in the two states of rest and during the painful procedure (Table 5).
Table 5
Correlation between mean scores of Comfort, NISS, and NRS before and during painful procedures
Variable | Comfort1 | NISS1 | NRS1 | |
|---|---|---|---|---|
Comfort1 | Pearson Correlation | 1 | 0.318** | 0.492** |
Sig. (2-tailed) | 0.007 | 0.000 | ||
N | 70 | 70 | 70 | |
NISS1 | Pearson Correlation | 0.318** | 1 | 0.178 |
Sig. (2-tailed) | 0.007 | 0.140 | ||
N | 70 | 70 | 70 | |
NRS1 | Pearson Correlation | 0.492** | 0.178 | 1 |
Sig. (2-tailed) | 0.000 | 0.140 | ||
N | 70 | 70 | 70 | |
Variable | Comfort2 | NISS2 | NRS2 | |
Comfort2 | Pearson Correlation | 1 | 0.273* | 0.322** |
Sig. (2-tailed) | 0.022 | 0.007 | ||
N | 70 | 70 | 70 | |
NISS2 | Pearson Correlation | 0.273* | 1 | 0.197 |
Sig. (2-tailed) | 0.022 | 0.102 | ||
N | 70 | 70 | 70 | |
NRS2 | Pearson Correlation | 0.322** | 0.197 | 1 |
Sig. (2-tailed) | 0.007 | 0.102 | ||
N | 70 | 70 | 70 |
According to the results, the Kappa coefficient of agreement shows values higher than 0.4 [37], so the agreement between the two evaluators at rest and during the painful procedure is acceptable and the reliability of the tool is confirmed (Table 6).
Table 6
Cronbach’s alpha and kappa coefficient of agreement between two evaluators
Condition | Correlation | Measure of Agreement | Approx. Sig. |
|---|---|---|---|
Cronbach’s Alpha | Kappa | ||
Resting-state | 0.746 | 0.058 | P = 0.000 |
During the painful procedure | 0.753 | 0.072 | P = 0.000 |
Discussion
Assessing pain and discomfort in ventilated children in PICUs is an essential nursing activity.
This should be done with appropriate tools for the patient’s age and clinical conditions. It should be noted that culture can significantly affect the behavioral responses of patients to pain. Also, the expression and behavioral manifestations of children’s pain may be varied in different countries [23]. Therefore, in the present study, the CBS version was translated and validated so that it could be used to assess pain and discomfort in children who are unable to provide verbal feedback, such as preverbal infants, sedated children, mechanically ventilated, and those with cognitive or communication disorders.
The CBS is adapted from the comfort scale, which is widely used in foreign studies [23]. To check the validity of the instrument, Ista et al. compared the physiological variables in the CBS with the comfort scale and concluded that without the physiological variables, the internal consistency measured by Cronbach’s alpha increased from 0.78 to 0.84. Therefore, the CBS is a reliable alternative to the comfort scale and has a better ability to be used in the PICU [33].
In the present study, the content validity of the CBS was conducted using both quantitative and qualitative methods, and it was used in the content validity according to the nursing experts of the PICU. According to the obtained statistical results, the content validity of the scale was confirmed. The distinguishing feature of the present study was the simultaneous examination of the content validity and reliability of the questionnaire, which had not been measured in any of the existing studies [7, 24, 25].
For discriminant validity in this study, a comparison of pain during resting and painful conditions was used. The results of the present study showed that the total score was significantly higher during the painful action compared to the resting state.
The proposed standard for assessing pain and comfort with the comfort scale requires routine assessment of vital signs every 3–6 h and should not be used in the first 20 min after procedures such as suction, position change, or patient movement [23]. In this study, the increase in pain of patients during an invasive procedure showed the validity of the pain assessment scale. To determine internal consistency, Cronbach’s alpha coefficient was calculated. The results of the study showed that there is a good correlation between the items in two situations (more than 0.7).
To determine the reliability between evaluators, the correlation coefficient between the observations of two evaluators who evaluated patients simultaneously was used. The obtained results showed a relatively good correlation between the evaluators (0.58 at rest and 0.72 during the painful procedure). According to the results of the present study in terms of the reliability of the evaluators, it can be said that the nurses’ understanding of the symptoms was the same and there was no different interpretation. In Johansson and Kokinsky’s study on 40 children with an average age of 4 months (119 observations) in Sweden, the kappa coefficient in the behavioral comfort tool was reported as 0.7 [24], which confirms the findings of the present study.
The results of Fagioli et al.‘s study in Italy on 35 children under 17 years hospitalized in the PICU (70 observations), showed that before the painful procedure, there was 100% agreement between the evaluators (kappa coefficient = 1) and after the painful procedure, they obtained a coefficient equal to 0.5 [7] In the present study, the agreement between evaluators before the painful procedure was lower (0.58), but it was higher after the painful procedure(0.72) which may be due to individual differences and personal perceptions of pain assessment. In general, if the Kappa agreement coefficient shows values higher than 0.4 [37] the reliability of the tool is confirmed. In the study of Rodrigues et al. on children aged 28 days to 16 years admitted to the pediatric intensive care unit of a hospital in Portugal, the internal consistency using Cronbach’s alpha was equal to 0.9 [25], which shows a higher consistency than the present study. Maybe the reason is the higher number of observations (646 times) compared to the present study (140 times).
For criterion validity, NISS and NRS were used simultaneously by two other nurses at the end of each evaluation for each patient. The result indicated the average correlation of the comfort tool with each of these tools. Johansson and Kokinsky in their study on children under 10 years of age with congenital heart diseases admitted to the PICU used two instruments CBS and FLACC as well as observational VASobs and NIS [24]. The results of their study indicated a moderate correlation between each of the tools and the comfort tool, which is in line with the results of the present study. Although the CBS provides more information in the assessment of child pain than other scales [24], one of the disadvantages of this instrument is that it does not examine emotional changes, skin color, sweating, and pupil size. It is suggested to consider these criteria in addition to this scale for more accurate evaluation of patients’ pain.
Conclusions
The findings of this study showed that CBS has good validity and reliability. By using this scale, pain management becomes possible in children with reduced levels of consciousness and a lack of verbal communication. Effective management of pain and unnecessary use of sedatives and painkillers helps to reduce medical complications, reduce length of hospital stay, reduce parental dissatisfaction with medical care, and ultimately reduce patient mortality. Therefore, it is recommended to include this scale in the file of children hospitalized in the PICU.
The present study was not without limitations. Because non-painful and painful measures were pre-defined, knowing this may have influenced raters’ ratings. Of course, good inter-rater reliability can reduce this concern. Another limitation of this study was the observation of only 70 patients, so it is suggested that future studies of this tool be done with a larger sample size to better determine its scientific and practical application. This study was conducted only in one of the hospitals with special care for children in Tehran, it is suggested to use this tool in hospitals of other cities and evaluate the acceptance and simplicity of the tool.
Acknowledgements
This article is a part of the pediatric nursing master’s thesis, which was approved with the number IR.IAU.TMU.REC.1403.099 dated 20/02/2024. The authors would like to express their gratitude to all the children and their parents in the research, the research assistants of the university, as well as PICU nurses and officials who helped us in conducting this research.
Declarations
Ethics approval and consent to participate
Research Council and Ethics Committee of the Medical Sciences Branch, Islamic Azad University, Tehran, Iran, approved this study (IR.IAU.TMU.REC.1403.099 dated 20/02/2024). All patients were observed during routine daily care. No expenses were imposed on them during the research or any additional intervention. Informed consent was obtained from the parents and legal guardians of the children. Informed verbal consent was also obtained from nurses to determine the tool’s validity. All methods followed the ethical declarations’ relevant guidelines and provisions.
Consent for publication
Not Applicable.
Competing interests
The authors declare no competing interests.
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