Comparative Evaluation of Two Active Distraction Techniques during Intraoral Local Anesthesia Administration among 3–6-year-old Children: A Randomized Controlled Trial

Abstract

Aim

A common and inevitable intrusive technique that causes anxiety in people of all ages, but particularly in young ones, is local anesthesia. A variety of behavioral management strategies, including active distraction tactics such as having a communication with the child, deep breathing, Writing In The Air Using Leg (WITAUL), and stress balls, are available to help reduce anxiety brought on by local anesthesia. The purpose of this study was to assess and compare the behavioral management techniques: stress ball and the hands–eyes–mouth distraction technique (HEM-DT).

Materials and methods

Three groups of 60 preschool children participated in the study: group I (control group: communication), group II (stress ball distraction), and group III (HEM-DT). After applying topical lidocaine gel to the buccal mucosa, local anesthetic (LA) was deposited. The Wong–Baker Faces Pain Rating Scale (WBFPRS) was used to measure dental pain following the administration of local anesthesia, while the Facial Image Scale (FIS) was used to measure anxiety. A pulse oximeter was used to measure the pulse rate. An analysis of variance (ANOVA) was used to compare the groups (p < 0.05).

Results

HEM-DT showed significant difference on comparing pre-FIS and post-FIS scores, with a p-value of 0.014. Pulse rate was comparatively lesser in HEM-DT. When comparing WBFPRS between the three groups, HEM-DT exhibited significant difference.

Conclusion

HEM-DT technique was found to be better than stress ball technique and communication.

Clinical significance

The HEM-DT is a useful tool in pediatric dentistry that helps divert a child's attention from the needle and reduce their pain perception during various treatments.

How to cite this article

Vijayakumar PM, Mathew BM, Banu N, et al. Comparative Evaluation of Two Active Distraction Techniques during Intraoral Local Anesthesia Administration among 3–6-year-old Children: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2025;18(8):907–910.

Introduction

Anxiety is described as a fear of the unknown. Children's first dental appointment is typically accompanied by worry, trepidation, and dental terror. Routine dental care may be hampered by a pattern of consistently poor responses. Therefore, it is crucial to shape the child's perspective about dentistry during their initial dental encounter. Although it appears to affect children and teenagers more than adults, dental anxiety is a widespread problem that affects people of all ages. Both the pediatric dentist and the child may have unpleasant experiences as a result of the dentist's behavior management issues. Local anesthesia is a primary and inevitable invasive procedure in pediatric dentistry, which causes anxiety in children.¹ In order to reduce the anxiety brought on by local anesthetics (LA), pediatric dentists have been employing a variety of behavioral management strategies.²

One of the most commonly used nonpharmacological behavioral guidance techniques is distraction. The method lessens discomfort and anxiety by diverting the child's attention to something interesting and appealing.^1,3 The literature offers a range of active distraction strategies, including talking to the child, deep breathing, the hands–eyes–mouth distraction technique (HEM-DT), Writing In The Air Using Leg (WITAUL), and stress balls.^3,4

In HEM-DT, to distract them, the patient is told to do a series of motions that resemble games, and in stress ball, patients were asked to play with stress ball during LA administration. It is linked to memory and motor abilities and is multisensory. The psychology of clapping involves the coordination of motor skills. The startle response of the listener's midbrain appears to be involved in the particular sudden sound of clapping, transforming it into a useful signal to refocus attention.⁵ The capacity to generate a goal-oriented hand activity that is directed by visual input from the eyes is known as eye–hand coordination (EHC). When performing a certain motor action, eye movements are crucial.⁶

There is currently little information available regarding the effectiveness of distraction techniques in children younger than 6 years old, despite the fact that prior clinical trials have evaluated the effectiveness of these techniques using different behavioral management techniques during intraoral local anesthesia management in children. This study evaluated and compared the effectiveness of two active distraction techniques, HEM-DT and stress ball with the conventional method, i.e., communication.

Materials and Methods

Ethical Clearance and Consent

This randomized, controlled study was conducted in Department of Pediatric and Preventive Dentistry (VMSDC/IEC/Approval no. 299) following approval by the institutional ethical and review committee and in compliance with the Declaration of Helsinki 1975's Ethical Principles for Medical Research Involving Human Subjects (revised 2013). Additionally, it was registered as a prospective research with CTRI number CTRI/2023/12/060875 in the Clinical Trials Registry, India. Before the study began, parents gave their written informed consent.

Sample Size Calculation and Sampling

Based on the Leyda-Menéndez et al.'s² study, the required sample size was determined to be 60 with an age-group of 3–6 years after the research's statistical power was established at 95%, and the margin error was 16%, with a significance threshold at p < 0.05. Simple random sampling method was used for grouping of the children in equal numbers.

Children in their first dental visit with age cluster of 3–6 years, requiring buccal infiltration for extraction/pulp therapy for deep carious lesions, with Frankl's behavior rating scale of 3 and 4 were included for the study. The exclusion criteria include children with intellectual disabilities or neurological diseases, with systemic disorders, and those who are allergic to LA.

Two percent topical lidocaine gel was applied for 1 minute over the oral mucosal site (buccal). A 30-gauge needle was inserted, and 0.9 mL of 2% lidocaine with 1:1,00,000 epinephrine was deposited for the 60 children who fulfill the inclusion criteria.

Group I (Control Group—Communication) (n = 20)

During the LA procedure, communication was used as the conventional distraction technique.

Group II (Stress Ball Distraction) (n = 20)

A 5-cm (in diameter) lighted silicone stress ball was presented to the youngster by the operator. As part of therapy through play, the kid was engaged by being told to keep pushing the ball, concentrate, and watch the colors change, during which the LA was deposited with the same protocol.

Group III (Hands–Eyes–Mouth Distraction Technique) (n = 20)

In order to distract the child from puncturing needle and keep them from seeing it, the operator asked them to make a series of game-like motions. The child was given instructions on how to do this in the lobby and was required to practice it multiple times before settling into the dental chair. The sequence will consist of the child clapping the hands, putting his hands on his belly, opening his mouth, and closing his eyes each for a count of three consecutively, during which the LA was deposited.

Outcome Assessment

Outcome assessment was done by an examiner who is blinded to the assigned intervention. Pretreatment and posttreatment dental anxiety was assessed by the blinded examiner in the waiting area using Facial Image Scale (FIS).⁷ A pulse oximeter (Dr Trust USA Pulse Oximeter) was used to measure the children's pulse rate, and Wright's adaptation of Frankl's behavior rating scale⁸ was used to evaluate their behavior while LA was being administered. Wong–Baker Faces Pain Rating Scale (WBFPRS) was used to measure dental pain following the injection of local anesthesia.⁹

The statistical software IBM SPSS (version 22) was used to tabulate and analyze the acquired data.

Results

Table 1 compares the gender distributions across three groups using Chi-square test. The p-value of 0.072 indicates that there exists no statistically significant distinction in the distribution of sexes among the groups.

Table 1:

Comparison of gender distribution among three groups

Gender	Groups			p-value
	Group I n (%)	Group II n (%)	Group III n (%)
Male	10 (50)	15 (75)	8 (40)	0.072
Female	10 (50)	5 (25)	12 (60)

Table 2 compares the mean age and pulse rate (with standard deviation) across three groups using analysis of variance (ANOVA). The mean ages for each group were 5.3 years (±0.71) for group I, 5.2 years (±0.93) for group II, and 5.6 years (±0.67) for group III. The p-value of 0.255 indicates that there is definitely no statistically significant age difference between the groups. ANOVA was also used to compare the pulse rate measurements in the three groups (Table 2). With a p-value of 0.001, the groups' pulse rates differ statistically significantly. When compared with group I as well as group II, group III's pulse rate is noticeably lower.

Table 2:

Comparison of mean age-group and pulse rate among three groups

Gender	Groups			p-value
	Group I	Group II	Group III
Age	5.3 ± 0.71	5.2 ± 0.93	5.6 ± 0.67	0.255
Pulse rate	119.2 ± 7.2	108.3 ± 6.0	99.8 ± 5.9	0.001

Analysis of variance was used to compare WBFPRS and Frankl's behavior rating scale among the three groups (Table 3). The behavior scales did not significantly differ between the groups. Group I and group II differed significantly from group III when comparing WBFPRS.

Table 3:

Comparison of Frankl's behavior rating scale and WBFPRS between three groups

Dependent variable	(I) Group	(J) Group	Mean difference (I – J)	Significance	95% confidence interval
					Lower bound	Upper bound
Frankl's behavior rating scale	Group I	Group II	−0.050	0.578	−0.23	0.13
		Group III	−0.050	0.578	−0.23	0.13
	Group II	Group I	0.050	0.578	−0.13	0.23
		Group III	0.000	1.000	−0.18	0.18
	Group III	Group I	0.050	0.578	−0.13	0.23
		Group II	0.000	1.000	−0.18	0.18
WBFPRS (Postassessment)	Group I	Group II	2.100*	0.034	0.16	4.04
		Group III	5.350*	0.000	3.41	7.29
	Group II	Group I	−2.100*	0.034	−4.04	−0.16
		Group III	3.250*	0.001	1.31	5.19
	Group III	Group I	−5.350*	0.000	−7.29	−3.41
		Group II	−3.250*	0.001	−5.19	−1.31

*Mean difference is statistically significant

Preassessment FIS scores and postassessment FIS scores were compared among three groups using paired t-test (Table 4). Group III exhibited the statistical significance difference between the pre- and postassessment FIS score with a p-value of 0.014.

Table 4:

Comparison of FIS among three groups

FIS		Mean	Standard deviation	p-value
Group I	Preassessment FIS	1.9	1.4	0.073
	Postassessment FIS	1.4	0.8
Group II	Preassessment FIS	2.0	1.4	0.338
	Postassessment FIS	1.6	1.1
Group III	Preassessment FIS	2.4	1.5	0.014
	Postassessment FIS	1.4	0.75

Discussion

Since local anesthesia is uncomfortable and can cause anxiety in people of all ages, particularly in young ones, there are a number of behavioral management strategies available to reduce anxiety. The objective of this randomized controlled trial was to assess the effectiveness of two active behavioral management strategies applied during the administration of LA.¹⁰ In the current investigation, epinephrine in a 1:1,00,000 concentration combined with 2% lidocaine hydrochloride was used to give local anesthesia via buccal infiltration as per the previous studies.^11,12

For many years, the first technique—communication (group I)—was the standard method of distracting children from their attention. Both cooperative and noncooperative patients are treated in pediatric dentistry via communicative guidance and the proper use of instructions. At the beginning of a dental appointment, asking questions and engaging in active/reflective listening can aid in establishing rapport, promote faith, and reduce anxiety. Patients can voice their concerns and ask questions regarding their therapy through communication techniques such as ask-tell-ask. In order to establish rapport and foster trust, a dentist must be able to empathize with patients, listen to their worries, and engage in two-way communication. This helps to reduce anxiety.¹³

Positive reinforcement given after the LA injection serves as positive feedback, reduces fear, and raises the possibility that the behavior will reoccur. The second technique, the stress ball technique (group II), is based on the idea of play therapy, in which a therapist employs play materials, such as stress ball/rubber ball that is soft in texture that shows variations in color and shape when hard-pressed, to address psychological problems such as anxiety. This technique has been applied to actively distract patients during pediatric surgical procedures in order to manage discomfort^14,15; the third method HEM-DT (group III) is a relatively recent approach that relies on the patient's verbal communication, motor, multisensory, memory, and distraction skills. As a result, children who are more focused on the game experience confusion and distraction during the administration of LA, which improves EHC.²

According to results obtained, dental pain (WBFPRS) was minimum showing happy faces during the LA administration while using HEM-DT (group III). This could be due to distraction of sight of needle and usage of 30-gauge needle causing less pain perception. Aydin et al.¹⁵ and Girgin and Göl¹⁶ found that use of a stress ball was effective in decreasing pain and anxiety when used during phlebotomy and venipuncture, respectively, in 7–12-year age-group.

Pulse rate was reduced in HEM-DT technique when compared to the other two groups in our study and was similar to study done by Leyda-Menéndez et al.² According to results, children in group III seemed to be more at ease during the injection, but children in other groups showed an upsurge in pulse rate. This could be because HEM-DT let the patient focus on something other than the stimulator of stress.

Most of the children had good or highly favorable behaviors during buccal infiltration, and there were no discernible variations in patient behavior across the groups. It is also important to remember that the Frankl's behavior rating scale¹⁷ does not assess patients' anxiety levels before to therapy; rather, it solely categorizes patients based on their degree of cooperation.¹⁸ The FIS was utilized in the present investigation to evaluate the latter.

The results of the current study demonstrated that children's anxiety levels varied between pre- and postassessment. Significant differences between the other groups were shown by HEM-DT. The third group had the lowest anxiety levels, similar to the research by Leyda-Menéndez et al.²

The limitations of the study include buccal infiltration was not employed on lower primary molars for pulp therapy or extractions, only preschool-aged children were chosen, and training them proved challenging. Additionally, there was no assessment of preanesthetic pain levels and comparison. Not many kids who were staring at the glowing stress ball were scared.

Conclusion

When compared to a stress ball, HEM-DT has a favorable impact on dental pain and reduces pain perception in children aged 3–6 years during LA administration. The HEM-DT is a useful tool for a variety of dental treatments in pediatric dentistry. Both methods, though, can be utilized to help the youngster feel less discomfort and divert their attention from the needle.

Clinical Significance

In pediatric dentistry, the HEM-DT is a helpful tool that helps distract children from needles to lessen their sense of discomfort during various procedures.

Orcid

Basil M Mathew https://orcid.org/0000-0003-0446-012X

Veena Arali https://orcid.org/0000-0002-6614-3405