Comparative efficacy of virtual reality headset and auditory distraction for reducing anxiety and pain during inferior alveolar nerve block in 7-10-year-old children: A clinical trial

doi:10.21203/rs.3.rs-4618823/v1

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Comparative efficacy of virtual reality headset and auditory distraction for reducing anxiety and pain during inferior alveolar nerve block in 7-10-year-old children: A clinical trial

https://doi.org/10.21203/rs.3.rs-4618823/v1

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Objectives: Pain and anxiety are not limited to a certain age group; however, their thresholds are closely correlated with age, and they can cause irreversible mental disorders in children. This study compared the efficacy of a virtual reality (VR) headset and auditory distraction for reducing anxiety and pain in 7- to 10-year-old children during inferior alveolar nerve block (IANB) injection.

Materials and Methods: This randomized clinical trial included 45 patients who required an IANB. The children were randomly assigned to 3 groups (n=15) to use a VR headset, headphones, or no distraction (control) during the IANB. The pain experienced by the children during the injection was quantified subjectively using the Wong-Baker FACES pain rating scale (WBFPS) and objectively using the Face Leg Activity Cry Consolability (FLACC) scale. Anxiety was quantified subjectively using the Facial Image Scale (FIS) and objectively by measuring changes in heart rate (HR) and blood pressure (BP). The data were analyzed using SPSS 19 (alpha=0.05).

Results: The mean age of the patients was 8.31±1.07 years. There were no significant differences in age or sex distribution among the three groups (P>0.05). Significant differences were found in the FLACC (P=0.000), WBFPS (P=0.011), and FIS (P=0.020) scores after the injection among the three groups; the headphone group had the highest scores, and the VR group had the lowest scores.

The mean change in systolic BP was significantly different among the three groups (P=0.00), and the VR headset group experienced the smallest increase in BP. The differences in diastolic BP (P=0.291) and HR changes were not significant among the groups (P=0.062).

Conclusion: Using a VR headset significantly decreased anxiety and pain during the IANB, while using headphones had no particular advantage.

Trail Registration:

The ethics committee of the university (IR.SSU.DENTISTRY.REC.1401.072)

The Iranian Registry of Clinical Trials (IRCT20230614058486N1)

Children

Dental Anxiety

Pain

Virtual Reality

Distraction

Pain is an unpleasant and annoying sensation that often occurs following an injury or indicates the possibility of an injury [1]. Pain is an alarming signal for the human body to prevent further damage. Anxiety is defined as an unpleasant sense of stress and concern of unknown origin and is characterized by restlessness, uncertainty, helplessness, and physiological arousal [2]. Pain and anxiety are not limited to a certain age group; however, their thresholds are closely correlated with age, and they can cause irreversible mental disorders in children, who are the most sensitive age group to pain and anxiety [3]. Additionally, dental pain and anxiety can adversely affect patient compliance with treatment and future dental visits [4].

The management of pain and anxiety is a high priority in dental care for children. Children with high levels of dental fear and anxiety often avoid seeking dental care, which increases their rate of caries and compromises their oral health [5].

Dental anesthesia injection is the most common method of pain control during dental procedures [6]. However, anesthetic agents are administered by needle injection, and trypanophobia or intense fear of needles is the most common cause of dental anxiety in children [7]. Thus, anesthetic injection is a stressful task for both patients and pedodontists [8].

Pharmaceutical interventions, such as the administration of analgesic agents, are also used for the reduction of pain and anxiety in children during dental procedures; however, they also have side effects and complications [9].

Researchers working on noninvasive pain control measures suggest distraction as a simple and noninvasive technique for reducing pain and anxiety [10]. Distraction decelerates the speed of transfer of pain and anxiety signals and decreases the severity of pain and anxiety [11]. Many studies have emphasized the necessity of distraction during dental procedures, particularly local anesthetic injections, and have recommended distraction for the effective reduction of pain and discomfort in children [6, 12, 13]. Distraction can be auditory, visual, or both, and the use of audiovisual tools for distraction may serve as an effective supplementary tool in dental procedures [14].

VR is a novel audiovisual technology that simulates an experience that can be similar to or different from reality [15]. Evidence shows that VR therapy can be effective for pain relief and the treatment of anxiety and depression [16–18]. Treatment with VR is performed through distraction and full immersion of the patient in the virtual environment [19]. It has been demonstrated that children treated with VR have a greater level of cooperation and experience less pain [15, 20]. VR headset/glasses were first introduced to the market by Google in 2013 [21].

Considering the significance of the management of dental pain and anxiety in children and the gap in information regarding the actual efficacy of VR headsets for reducing pain and anxiety in children during anesthetic injections, this study aimed to compare the efficacy of VR headsets and auditory distraction for reducing anxiety and pain in 7- to 10-year-old children during inferior alveolar nerve block (IANB) injection.

This study was conducted at the Pediatric Dentistry Department of the School of Dentistry, Yazd University of Medical Sciences between November 2022 and April 2023. The study protocol was approved by the ethics committee of the university (IR.SSU.DENTISTRY.REC.1401.072) and registered in the Iranian Registry of Clinical Trials (IRCT20230614058486N1).

Trial design:

A parallel-group randomized clinical trial in which the children received an IANB under audiovisual distraction by using a VR headset in the first intervention group, under auditory distraction by using headphones in the second intervention group, and with no distraction in the control group was conducted. The results were reported according to the criteria derived from the Consolidated Standards of Reporting Trials.

Participants, eligibility criteria, and settings:

The inclusion criteria were 7- to 10-year-old children with carious mandibular primary molars requiring an IANB, no history of intraoral injection, no allergy to lidocaine, no history of pain due to pulpitis, no experience of unsuccessful dental treatment, and no history of adverse dental or medical experiences.

The exclusion criteria were children with primary anxiety disorders and uncooperative children.

The sample consisted of 45 children between 7 and 10 years of age who were selected among children who presented to the Pediatric Dentistry Department of the School of Dentistry, Yazd University of Medical Sciences, by convenience sampling.

Interventions:

After providing written informed consent from the parents or legal guardians of the children, eligible children who were willing to participate in the study were enrolled. The children were randomly assigned to three groups, including two intervention groups and one control group (n = 15). The children in the first intervention group received an audiovisual VR headset (LEJI VR MINI Virtual Reality Headset; China) that could be connected to a cell phone, while the children in the second intervention group received headphones (Sierra Headset SR-WH200, USA). Group 3 served as the control group and did not receive any distractions. The Elsa and Anna animations were shown to children in the first intervention group, while children in the second intervention group listened only to them. In the first treatment session, children in all three groups underwent prophylaxis and fluoride therapy and were familiarized with the office environment and dental instruments through the tell-show-do technique. In the second treatment session, the first intervention group was provided with instructions on how to use the audiovisual VR headset before anesthetic injection. They wore the headset, and the animation started to play. After the child had watched and adapted for 1 minute, 20% topical benzocaine gel (Prodofix, Iran) was applied to the dry mucosa at the injection site with a cotton roll for topical anesthesia induction. Next, an IANB injection was performed using 1.8 mL of 2% lidocaine plus 1:100,000 epinephrine (Persocain E; Lidocaine HCl Darupakhsh Pharmaceutical MfaCo., Iran) within 1 minute. A 27-gauge short (25 mm) needle was used for the injection. In the second intervention group, the children were provided with headphones and instructed on how to use them. The children in the second intervention group did not have goggles and only heard the sound of the animation. The rest of the procedure was the same as that explained for the first intervention group. The third group served as the control group, and the children received IANB with no auditory or audiovisual distraction. The heart rate (HR) and blood pressure (BP) of patients were measured before and 1–2 minutes after the IANB injection by a digital wrist blood pressure monitor (KBM320; Japan), which was attached to the children’s wrist before the procedure. HR and BP were measured as physiological indices of anxiety. The Facial Image Scale (FIS), which has five faces with happy to sad expressions, was also used for the subjective assessment of anxiety. The faces were shown to the children, and they were asked to select the face that best described their current state. Faces #3, 4, and 5 indicated moderate to severe anxiety (Fig. 1).

The level of pain experienced by patients during IANB injection was quantified subjectively by using the Wong-Baker FACES Pain Rating Scale (WBFPS) [22] and objectively by using the Face Leg Activity Cry Consolability (FLACC) scale [23]. The WBFPS has 6 facial expressions showing different levels of pain from the lowest (left end) to the highest (right end), with scores ranging from 0 to 5. A score of 0 indicates no pain, a score of 1 indicates mild pain, a score of 2 indicates moderate pain, a score of 3 indicates almost severe pain, a score of 4 indicates severe pain, and a score of 5 indicates the most severe pain imaginable [24]. The children were asked to express the level of pain they experienced by using one of the faces that best described their feelings.

The FLACC scale has five domains, namely, facial expression, leg movements, activity of the child, crying, and consolability of the child, and each domain is scored from 0 to 2. The sum of the scores, which ranged from 0 to 10, was then calculated and reported (Fig. 2).

The pain and anxiety assessments (except for FLACC) were performed by a senior postgraduate student in pediatric dentistry. The FLACC was used by another postgraduate student in pediatric dentistry.

Ten minutes after the injection, the dental procedure was performed for the patients.

Outcomes (primary and secondary):

Pain and anxiety were the primary outcomes of this study. There was no secondary outcome.

Sample size calculation:

The sample size was calculated to be a minimum of 10 children according to a study by Haghgoo et al. [25], assuming that the mean pain score was 3 ± 0.81 in the control group and 1.99 ± 0.65 in the VR headset group, with an alpha = 5%, a study power of 80%, and an error rate equal to the difference between the means using the PASS15. Considering the possibility of 20% dropout, the minimum sample size was calculated to be 12. To increase accuracy, 15 children were assigned to each group.

Interim analyses and stopping guidelines:

No interim analyses were performed, and no stopping guidelines were established.

Randomization:

The children were randomly assigned to three groups by the generation of random numbers via the random allocation software program.

Blinding:

Blinding was not possible in this study due to the nature of the interventions.

Statistical analysis:

The normality of the data distribution was evaluated by the Kolmogorov‒Smirnov test. Accordingly, the mean pain and anxiety scores were compared among the groups by the Kruskal‒Wallis test (for general comparisons) and the Mann‒Whitney U test (for pairwise comparisons). ANOVA and Fisher’s exact test were applied to compare the mean change in BP and HR of the children and to compare the groups regarding age and sex distribution. All the statistical analyses were carried out using SPSS version 19 (SPSS Inc., IL, USA) at a 0.05 level of significance.

Participant flow:

The sample consisted of 45 children, including 25 boys (55.6%) and 20 girls (44.4%). There were 8 girls and 7 boys in the VR headset group, 6 girls and 9 boys in the headphone group, and 6 girls and 9 boys in the control group. The difference in sex distribution was not significant among the three groups (P = 0.452, Fisher’s exact test). The mean age of the children was 8.31 ± 1.07 years (range 7–10 years). The mean age was 8.06 ± 0.90 years in the VR group, 8.30 ± 1.06 years in the headphone group, and 8.56 ± 1.23 years in the control group, with no significant difference (P = 0.698, ANOVA). Figure 3 shows the CONSORT flow diagram of patient selection and allocation.

Harms:

No patients were harmed during the study.

Subgroup analyses:

Objective assessment of anxiety according to BP: Table 1 presents the mean systolic and diastolic BP in the three groups before and after IANB injection. The systolic BP increased in all the groups after the injection. The three groups had a significant difference in the mean change in BP (P = 0.0001); pairwise comparisons showed a significantly lower mean change in the VR headset group than in the control group (P = 0.029) and the headphone group (P = 0.0001). However, the difference between the headphone and control groups was not significant (P = 0.227). Despite the increase in diastolic BP in the three groups after the injection compared with baseline, the three groups had no significant difference in the mean change in diastolic BP (P = 0.291).

Table 1

Mean systolic and diastolic BP (mmHg) in the three groups before and after IANB injection (n = 15)
BP	Group	Before injection SD ± Mean	After injection SD ± Mean	Mean difference	P value*
Systolic	VR	101.13 ± 8.95	107.20 ± 6.83	6.06 ± 2.65	0.0001
	Auditory headset	105.80 ± 8.78	117.40 ± 6.97	11.60 ± 4.43
	Control	112.93 ± 7.17	122.40 ± 6.12	9.46 ± 3.13
Diastolic	VR	71.13 ± 6.89	77.47 ± 7.06	7.53 ± 6.33	0.291
	Auditory headset	76.67 ± 5.66	85.00 ± 5.66	8.33 ± 5.47
	Control	83.67 ± 4.86	90.07 ± 3.15	6.20 ± 3.12
SD: standard deviation; *ANOVA

Objective assessment of anxiety according to HR: Table 2 shows the mean HR of children before and after IANB injection in the three groups. The HR increased after injection compared with baseline in all three groups. There was no significant difference in the mean change in HR among the three groups (P = 0.062).

Table 2

Mean HR of children before and after IANB injection in the three groups (n = 15)
Group	Before injection SD ± Mean	After injection SD ± Mean	Mean difference	P value*
VR	78.13 ± 13.17	101.27 ± 13.80	23.13 ± 6.87	0.062
Headphones	79.11 ± 7.57	108.00 ± 10.63	28.53 ± 9.89
Control	88.67 ± 5.67	110.73 ± 7.78	22.06 ± 6.08
SD: standard deviation; *ANOVA

Subjective assessment of anxiety using the FIS: The mean FIS score was the highest in the headphone group, followed by the control group and then the VR group. This difference was statistically significant among the three groups (P = 0.020, Table 3). Pairwise comparisons by the Mann‒Whitney test revealed that the mean FIS of the headphone group was significantly greater than that of the VR group (P = 0.008). The mean FIS was not significantly different between the VR and control (P = 0.267) or between the headphone and control (P = 0.072) groups.

Table 3

Mean FLACC, WBFPS and FIS scores in the three groups (n = 15)
Group	FLACC SD ± Mean	WBFPS SD ± Mean	FIS SD ± Mean
VR	0.93 ± 0.96	0.93 ± 0.79	1.87 ± 0.74
Headphones	4.2 ± 2.73	2.13 ± 1.18	3.07 ± 1.28
Control	2.53 ± 2.03	1.73 ± 0.961	2.27 ± 0.961
P value*	0.0001	0.011	0.020
SD: standard deviation; *Kruskal‒Wallis test

Objective pain assessment using FLACC: The mean FLACC score was the highest in the headphone group, followed by the control group and the VR group. This difference was statistically significant among the three groups (P = 0.0001, Table 3). Pairwise comparisons by the Mann‒Whitney test revealed that the mean FLACC score in the headphone group was significantly greater than that in the VR group (P < 0.001). Additionally, the mean FLACC score in the VR group was significantly lower than that in the control group (P = 0.006). There was no significant difference in this regard between the headphone and control groups (P = 0.060).

Subjective pain assessment using the WBFPS: The mean WBFPS score was the highest in the headphone group, followed by the control group and the VR group. This difference was statistically significant among the three groups (P = 0.011, Table 3). Pairwise comparisons by the Mann‒Whitney test revealed that the mean WBFPS score was significantly greater in the headphone group than in the VR group (P = 0.006). The mean WBFPS score of the VR group was also significantly lower than that of the control group (P = 0.025). The difference in this regard was not significant between the headphone and control groups (P = 0.320).

This study compared the efficacy of VR headset and auditory distraction for reducing anxiety and pain in children between 7 and 10 years of age during IANB injection. The results showed a significantly smaller change in systolic blood pressure compared with baseline in the VR group than in the other groups. However, the difference in this regard was not significant between the headphone and control groups. The differences in diastolic BP and HR were not significant among the three groups. Koticha et al. [26] and Nunna et al. [27] showed a significant reduction in HR after treatment in the intervention group, which was in contrast to the present findings, probably due to different types of interventions (extraction in their study versus IANB injection in the present study). None of the similar previous studies assessed the systolic and diastolic BP of patients to compare our results with [28–30].

The mean WBFPS score was significantly different among the three groups in the current study and was the lowest in the VR group. The same results were obtained for the FLACC score. These results were in agreement with the findings of several previous studies [12, 25, 28–34]. In studies by Aminabadi et al. [28] and Haghgoo et al. [25], the mean pain score was significantly lower in the VR headset group than in the control group. It should be noted that patients were between 4 and 6 years of age in the study by Aminabadi et al. [28] and between 6 and 8 years of age in the study by Haghgoo et al. [25], and they both used the Modified Child Dental Anxiety Scale for the measurement of anxiety. Kaur et al. [31] reported significantly less pain and anxiety in the audiovisual group than in the auditory group, which was in agreement with the present findings. However, they evaluated children between 4–6 and 6–8 years of age. Thus, it appears that audiovisual distraction is more effective than auditory distraction for the management of anxious children.

Al-Halabi et al. [12] reported that distraction by watching a movie on a tablet was the most effective method for reducing dental pain and anxiety in children during an IANB; although the VR headset was significantly more effective than the control group in reducing pain and anxiety, it was less effective than the tablet.

In a meta-analysis, López-Valverde et al. [32] evaluated the use of VR for the management of dental pain and anxiety and confirmed that VR can serve as an effective distraction tool for this purpose. Their results were in line with the present findings. Mohammadpour et al. [34] assessed the effect of VR on the anxiety of adult patients before dental surgery and reported that VR significantly decreased anxiety scores compared with those of the control group. Their results were similar to the present findings, although they evaluated an adult population.

However, the current results were in contrast to the findings of Nunna et al. [27] and Kaur et al. [31] since they found no significant difference between the intervention and control groups in terms of pain and anxiety. Nunna et al. [27] used the WBFPS and a visual analog scale (VAS) for the quantification of pain after injection. The same scales were used by Kaur et al. [31]. The differences between their results and the present findings may be due to their larger sample size and use of the VAS.

The FIS was used for the assessment of anxiety in children in the present study, which only indicates the state of anxiety [35, 36]. Nonetheless, the results revealed a significant difference in the FIS among the three groups, such that the VR headset group had the lowest FIS. Sridhar et al. [36] and Bahrololoomi et al. [37] assessed the efficacy of VR headsets and breathing exercises using a bubble blower as methods of distraction and relaxation for pain reduction in pediatric dental patients. They showed that both methods were equally effective, whereas in the present study, the VR headset was significantly more effective than headphones. Several other studies reported a reduction in anxiety scores of children in the VR group, indicating its optimal efficacy for reducing anxiety in children [25, 28, 31, 33].

Shetty et al. [30] used the SCARED Scale for Child Anxiety-Related Disorders, Nunna et al. [27] used the Venham Behavior Rating Scale for the assessment of anxiety, and both studies reported significantly lower anxiety scores in the VR distraction group, which was in agreement with the present results, despite the use of different scales. Koticha et al. [26] assessed the efficacy of VR glasses as an aid for distraction and reduction of anxiety in children undergoing tooth extraction. They reported a significantly lower pulse rate in the intervention group; however, the difference in anxiety was not significant between the intervention and control groups. In other words, VR distraction improved physiological parameters in 6- to 10-year-old children in their study but did not decrease the self-reported anxiety of patients according to the Venham scale. Their findings were different from the present results, which may be due to the use of a different scale for the quantification of anxiety.

This study had several limitations. Treatments were performed at the Pediatric Dentistry Department of the university in a public, nonisolated room. Thus, crying and poor cooperation of other children could have had a confounding effect on the anxiety of other children. Additionally, the sample size was limited due to the strict inclusion criteria, and the selected study population may not be representative of the entire population of pediatric dental patients. Furthermore, blinding of patients and researchers was not possible due to the type of intervention.

Future studies on the efficacy of VR headsets for the distraction of children undergoing more stressful dental procedures, such as tooth extraction, are needed. Additionally, the efficacy of VR headsets should be compared with that of other distraction and behavioral control methods for reducing anxiety and pain in pediatric dental patients.

Using the VR headset significantly decreased the anxiety and pain of 7- to 10-year-old children during IANB injection, while using headphones had no particular advantage in this respect.

BP Blood Pressure

HR Heart rate

FIS Facial Image Scale

FLACC Face Leg Activity Cry Consolability

VR Virtual Reality

WBFPS Wong-Baker FACES Pain Rating Scale

Ethics approval and consent to participate

This study was approved by Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board, Taiwan (KMUHIRB-SV(II)-20200062). Written informed consent was obtained from all participants. All methods were carried out in accordance with declaration of Helsinki.

Consent for publication

Not applicable.

Availability of data and materials

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

Competing interests

The authors declare no competing interests.

Funding

Not applicable.

Authors' contributions

The first author ZB has contributed to the management, supervision of the whole process, revision, edit, and approval of this manuscript. The second author KV has contributed to the project conception, research inception, participant recruitment, management, data collection, analysis, and drafting and editing of the manuscript in its entirety. Third author MI has contributed to the writing, revision, edit, and approval of this manuscript. The fourth author ZP have contributed to data collection and approval of this manuscript. All authors reviewed the manuscript.

Corresponding author

Correspondence to [email protected]

Acknowledgements

We would like to thank the students who participated in this study.

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No competing interests reported.

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21 Jun, 2024

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Comparative efficacy of virtual reality headset and auditory distraction for reducing anxiety and pain during inferior alveolar nerve block in 7-10-year-old children: A clinical trial

Status:

Version 1

Abstract

Figures

Introduction

Materials and Methods

Trial design:

Participants, eligibility criteria, and settings:

Interventions:

Outcomes (primary and secondary):

Sample size calculation:

Interim analyses and stopping guidelines:

Randomization:

Blinding:

Statistical analysis:

Results

Participant flow:

Harms:

Subgroup analyses:

Discussion

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1