Ensuring a painless dental experience is crucial in minimizing anxiety and fear, promoting effortless delivery of treatment, establishing a trustworthy relationship between the dentist and the patient, and encouraging the child's willingness to undergo future treatments. Local anesthesia is a critical aspect of attaining these desired goals, but it remains one of the most challenging procedures in pediatric dentistry, and according to a systematic review, children experience the greatest degree of injection-related fear, highlighting the necessity for interventions to alleviate this fear [2]. One of the classic key techniques employed in pediatric dentistry is the use of distraction methods to help alleviate a child's discomfort during treatment procedures [24, 25]. In light of the numerous studies in general medicine that have indicated the efficacy of using tablets to reduce pain and anxiety in pediatric clinics [12], this current study was conducted to compare the effectiveness of AD and PD techniques during the administration of IANB injection.
The VR device was used in the current study based on the outcomes of previous studies that have established its effectiveness as a safe and reliable tool for passive distraction in order to relieve pain and anxiety during injections and dental procedures [13, 14]. The use of the VR device in this study aimed to prevent the children from anticipating the anesthesia procedure by concealing the needle from their view without requiring them to close their eyes, which could lead to fear or anxiety about the unknown. This approach is recommended by some practitioners who recognize the potential negative impact of preparing the needle in front of the child or mentioning the word "injection" during dental procedures [26]. the device was utilized on two groups of patients who required non-emergency dental treatment that involved an injection of IANB.
The current study relied on the parallel design to eliminate the carryover effect [27]. and to correspond with the entry criteria that include the child's use of the VR device for the first time. The sample for this study was chosen from the middle childhood stage, according to Nelson's classification [28], and consisted of children aged between 6–10 years. As the successful use of the device requires a good level of cooperation and awareness, participants with emergency cases or uncooperative behavior were excluded in order to minimize negative behavior and obtain results that were not influenced by different behavior patterns [29]. The study groups were established using a random distribution table, and the statistical analysis demonstrated that the sample was homogeneous in terms of age and gender. This approach was employed to neutralize any potential selection bias [30]. In order to enhance the principle of reliability, the study standardized the work environment by using the same distraction tool for both active and passive distraction. The work steps were also designed in a simple and repeatable way, which further neutralized the performance bias [30]. The current study is also one of the few studies in the field of distraction that used double-blinded for both the researcher and the co-evaluators, thus neutralizing the detection bias [30].
AAPD recommends that subjective, behavioral, and biological pain scales should be used as the most important measures for assessing pain in children [10] and that the subjective pain scale has been identified as the gold standard for children aged 6 years and older [31, 32]. Our research used the WBF scale as a subjective scale for pain, as it is designed for the age group of 4–12 years [10], which matches the age range of the children who participated in our study. Additionally, we took into account the children's preference for this scale [33]. Due to these reasons, we decided to exclude the visual analog scale intended for children aged 8 years and above [32].
The FLACC scale was also used as a behavioral scale of pain, based on a systematic review conducted in 2007, which proved the reliability and validity of the scale and recommended its use in children aged 3–18 years [34].
Furthermore, previous research has demonstrated the effective and straightforward utilization of both the WBF and FLACC scales among children within similar environments as those in the present study [4, 5]. Additionally, our study found a significant correlation between these two scales, indicating that an increase in one is associated with an increase in the other. HR measurement is the most common biological pain scale for children because of that it was used as the biological scale of the current study to enhance the accuracy of the subjective pain scale, thereby increasing the ability to describe the quality of the response to painful stimuli and allowing for a more comprehensive interpretation of the results [31, 32]. To achieve this goal, a smartwatch was employed as the measuring tool due to its proven effectiveness in natural conditions [35]. Additionally, unlike the oximeter device used in the Attar & Baghdadi's study [8], the smartwatch does not hinder hand movement during play.
The findings of the WBF subjective scale indicated that there were no statistically significant differences between the two study groups. Most of the study participants in both groups selected the facial expression that represented no pain, which aligns with the subjective scale results of Shekhar's study which used VR glasses for PD and a stress ball for AD [17]. Our study's results were consistent with those of Attar & Baghdadi's study in terms of the WBF scale values for the highest pain levels experienced during local anesthesia, However, it should be noted that their study found a statistically significant difference in favor of AD [8], where two of the children in our study sample chose the face that expresses the worst feeling of pain in the PD group, and no child chose this face in the AD group. This suggests that AD is more effective than PD in alleviating the most intense pain and avoiding the child's crying, this superiority may be more evident in cases of severe pain rather than mild pain or the absence of pain.
On the contrary, our study differed from Guinot et al, Arıkan, and MacLaren studies [16, 36, 37]. Guinot's study, which used VR for both study groups during dental treatment, showed a clear superiority of AD over PD [16]. The reason for this difference may be due to the fact that the child was asked about his feeling after the completion of the treatment completely and not immediately after anesthesia, which may affect the child's self-report. Arıkan's study showed lower levels of pain in the AD group as well [36]. The reason for this difference with the results of our study may be attributed to the use of an audible colored toy wristband that was designed by the researcher to emit music twice when pressed, which may not have been adequate for distraction in the PD group. While in the MacLaren study, they used a DVD player for PD and an interactive toy for AD, and it showed the superiority of PD over active distraction contrary to the results of other studies [37]; The reason for the difference may be due to the small age group in their studies, as younger children may be more affected by watching [38].
The FLACC behavioral scale results showed no statistically significant differences between the two groups, as most patients exhibited mild discomfort behaviors in both groups. However, the AD group exhibited slightly lower expression and behavior indicative of pain compared to the PD group. Our findings are consistent with most studies that have used the behavioral scale [16, 17, 37]. However, our results differ from the study conducted by Attar & Baghdadi [8], which could be attributed to the evaluators not being blinded to the study group, thus increasing the possibility of evaluator bias.
In terms of the biological scale results, both needle insertion and local anesthetic administration were found to be associated with a statistically significant increase in the mean HR over the baseline value for each group separately, however, there were no statistically significant differences between the two groups, although the mean HR changes in the AD group were slightly smaller than the PD group. It should be noted that most of these changes fell within normal physiological states [39]. These results are consistent with the results of the Padminee study, which compared the effectiveness of distraction using Biofeedback Relaxation and watching cartoons using a VR device during local anesthesia, and relied on HR as a primary outcome [40]. While our study's biological scale results differed from those of Guinot et al., who found a statistically significant difference in HR values favoring the AD group [16], one possible reason for this difference is that HR was measured intermittently in their study, whereas in our study, it was measured continuously in order to record all values to enhance the accuracy of the results.
It is important to note that the consistency in the results obtained from the three different measures used in this study strongly supports the accuracy and reliability of the findings.
The study had a few limitations that should be taken into account. Firstly, the VR device used was relatively large in size, which may not be suitable for children with small faces. Secondly, the device covers a part of the face, which limits the ability to investigate facial expressions during the procedure of the assessment by the FLACC scale. To mitigate this limitation, camera was placed close to the face to capture facial expressions as accurately as possible.
In conclusion, the results of our clinical and research study highlight the significance of modern technologies and the need to use them in the field of dental sciences, particularly in pediatric dentistry. Our findings demonstrate that incorporating these technologies can offer to patients a positive and comfortable dental treatment experience, with minimal pain and discomfort. Device usability and its Adequate price make this technique a practical method that can be applied easily and frequently in pediatric clinics. These positive outcomes can positively impact a child's acceptance of dental treatment in the future and enhance the child's positive behavior and reduce the fear of receiving local anesthesia.