A Comparative Assessment of Three Different Behavior Modification Techniques Using Physiological and Psychological Parameters: An In Vivo Study

Abstract

Aim and background

The principal emotions of a child entering the dental operatory are usually fear and anxiety, which have an impact on their behavior during all future appointments. Over the past couple of decades, there has been a significant shift in professional and societal perspectives on handling child behavior. Hence, many dentists are interested in additional noninvasive alternatives to conventional behavior management techniques. Therefore, the goal of this study was to assess and relate the efficacy of three such minimally invasive, nonpharmacological behavior management methods in reducing dental anxiety by using certain physiological variables and an anxiety assessment scale (i.e., psychological variable), before and after a dental procedure.

Materials and methods

This single-blind, randomized clinical trial involved 88 subjects randomly allocated to four groups, who were treated under the influence of three different behavior management techniques (viz., audio distraction, aromatherapy, and clown therapy) and a conventional technique (control group). Anxiety levels were assessed using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS), and measuring the changes in their hemodynamic variables and salivary biomarkers, prior to, and following treatment. The data were tabulated and statistically analyzed using IBM Statistical Package for the Social Sciences (SPSS) version 21.0 statistical software.

Results

All three behavior management techniques assessed in this study were effective in lowering anxiety levels among the subjects. More specifically, audio distraction outperformed the other two techniques, followed by the aromatherapy technique, which was found to be better than clown therapy and control groups.

Conclusion

While all three methods are able to lower dental fear and anxiety in children, audio-distraction is better among the three at achieving the same.

Clinical significance

Results of this study have the potential to guide pediatric dentists in selecting evidence-based, patient-friendly approaches to behavior guidance, thereby improving the overall quality of care, reducing appointment durations, and fostering a more positive dental experience for children.

How to cite this article

Dey MK, Dhinsa K, Yadav G, et al. A Comparative Assessment of Three Different Behavior Modification Techniques Using Physiological and Psychological Parameters: An In Vivo Study. Int J Clin Pediatr Dent 2026;19(1):73–84.

Introduction

A significant issue in children is that dental fear and anxiety are considered to be a constraint in providing high-quality dental care. Its prevalence in minors has been estimated to range anywhere from 3 to 20%.¹ It can be triggered by looking at needles, blood, and dental handpieces, the sounds of airotors, ultrasonic scalers, and yelling, the odor of eugenol, wet gloves, and excavated dentin, and the experience of vibrations in the dental clinic. A child's first dental visit thus plays a crucial role in the extension or curtailment of dental anxiety. Dental anxiety may result from a bad first visit, which can have a detrimental effect on subsequent treatments.²

Thus, to provide the best possible dental care to their patients in a stress-free setting is one of the goals of dental practitioners. Dentists use their education, experience, and a variety of behavior management strategies to accomplish this.³ Commonly utilized nonpharmacological behavior management strategies, including tell-show-do, nonverbal communication, voice control, modeling, and distraction, work well for directing kids; however, some of these strategies' invasiveness restricts their acceptance.⁴ Given that dental anxiety is a common age-old issue among children worldwide, many new techniques have always been tried upon as long as they are believed to reduce anxiety and fear.

Distraction is a form of behavior management approach that has been found to be useful for treating children's dental issues. By helping the youngster concentrate on the audio, music distraction helps them ignore unpleasant stimuli, which can lower their anxiety levels. Additionally, it is widely accessible, noninvasive, and side-effect-free.⁵

Newer methods, such as aromatherapy, are also gaining popularity in managing uncooperative patients. This alternative medicine approach has gained attention as a way to manage anxiety in hospital settings and incorporates the therapeutic use of essential oils.⁶ Because lavender essential oil stimulates the parasympathetic nervous system, it may boost mood, reduce anxiety, and increase sedation.⁷

Apart from all the aforementioned techniques, children are also fond of watching animated shows of cartoons and funny videos, which helps them accept and understand even informative content with greater ease, thus bringing in the presence of clowns in hospitals, particularly in pediatric wards.⁸ Thus, another relatively novel nonpharmacological technique of behavior management is clown therapy, which involves the dentist treating his/her patients while dressed as a clown, or in the presence of clowns. The clowns' role in dentistry is to help young patients overcome their concerns and fears. By adopting holistic techniques, dental clowns add humor to the experience and establish an easy connection with the kids.⁹

A literature search turned up a few studies, performed using these three behavior modification techniques, which presented with inconsistent results. Hence, this study was carried out with the aim of evaluating and comparing the effectiveness of audio distraction, aromatherapy, and clown therapy in lowering dental anxiety among children, using psychological and physiological parameters.

Materials and Methods

Prior to commencement of the study, this research protocol underwent a thorough review and attained approval by the Institutional Ethical Committee to ensure compliance with ethical standards and was then registered with the Clinical Trial Registry-India (CTRI/2023/06/054043).

Study Design

Children between the ages of 4 and 11 years who reported to the outpatient department (OPD) of the Department of Pediatric Dentistry at the Sardar Patel Post Graduate Institute of Dental and Medical Sciences in Lucknow participated in the single-blind, randomized controlled experiment.

Inclusion Criteria

• Children within the age group of 4–11 years were having their first dental visit.

• Medically fit and healthy children [American Society of Anesthesiologists-I (ASA I)].¹⁰

• Children who fall under Wright's modification of Frankl's behavior rating scale of 2 (−) or 3 (+), which includes patients with either a negative or positive attitude, respectively.¹¹

• A child having a carious lesion in one of the primary molars, requiring restoration without the administration of local anesthesia.

Exclusion Criteria

• Children with special health care needs.

• Children who have pain or who require local anesthesia administration for treatment.

• Emergency needs such as drainage of an abscess or extraction.

Sample Size Estimation

The G*Power version 3.0 application was used for sample size estimation. It was estimated for one-way analysis of variance (ANOVA) and F-test, for four groups with equal sample size.

It was determined that for an alpha of 0.05, a power of 80%, and an effect size of 0.4 (measured for differences in anxiety scale between study groups), a minimum total sample size of 76 is required. As anxiety was measured on an ordinal scale, nonparametric test was used for inferential statistics. Thus, this sample size was inflated by 15% and the final sample size was calculated as 87.4, which was rounded off as 88 (i.e., 22 per group).

Randomization

Prior to the start of treatment, all subjects were blinded. To establish the intervention allocation, the lead investigator used a bowl of colorful chits (Fig. 1) to randomly assign eligible individuals to one of the following four groups (n = 22 per group):

Fig. 1:

Bowl of chits for randomized group allocation

• Group I: subjects undergo treatment while simultaneously listening to music (i.e., audio distraction) of their own choice using over-the-head headphones (Fig. 2).

• Group II: subjects undergo treatment under the influence of lavender essential oil aroma (Fig. 3) administered using a reed diffuser (i.e., aromatherapy).

• Group III: subjects treated by a dentist dressed as a clown (i.e., clown therapy, Fig. 4).

• Group IV: subjects were treated with the use of no specific behavior management technique.

Fig. 2:

Patient being treated under audio distraction

Fig. 3:

Patient being treated under aromatherapy

Fig. 4:

Patient being treated by a dentist dressed as a clown

Outcome Parameters

The level of anxiety in each subject was measured before and after intervention using psychological and physiological parameters, elaborated as follows (Figs 5A and B):

Figs 5.

A and B: (A) RMS-PS for evaluating anxiety in girls; (B) RMS-PS for evaluating anxiety in boys

Psychological Parameter

Dental anxiety score was recorded for each subject using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS). The RMS-PS comprises five faces of the same child exhibiting different kinds of emotions, from extremely happy to extremely unhappy (Figs 5A and B). Two sets of photographs are used for males and females. The subjects were asked to select the face that they felt most appropriately reflected how they were feeling at that moment. The scoring criteria of the RMS-PS, as per the face chosen, are listed as under:¹²

Scoring criteria of the RMS-PS
Score	Observation
1	Very happy face
2	Happy face
3	Sad face
4	Unhappy face
5	Very unhappy face

Physiological Variables

Two broad sets of physiological parameters were used to assess anxiety, each further consisting of three different parameters, as follows:

1. Hemodynamic variables:

   • Pulse rate: Was recorded for each subject with the use of a digital pulse oximeter.

   • Blood pressure (BP): Both systolic as well as diastolic blood pressure values were recorded for each subject, using a digital wrist-cuff sphygmomanometer.

   • Oxygen saturation (SpO₂) was recorded for each subject, using the digital pulse oximeter.

2. Salivary biomarkers:¹³

   • Salivary cortisol: Measured by using cortisol kit.

   • Salivary α-amylase: Measured using an enzyme-linked immunosorbent assay (ELISA) kit.

   • Salivary immunoglobulin A (IgA): Measured using the IgA test kit.

Samples of unstimulated saliva were obtained from the subjects before and after their treatment in sterile plastic containers, and then the biochemical assessment of the biomarkers mentioned above was performed at the institutional department of biochemistry.

Every observation made both prior to and following intervention was then input into groupwise Microsoft Excel spreadsheets and examined for any missing information.

Statistical Analysis

Data was examined using the IBM Statistical Package for the Social Sciences (SPSS) Statistics 21 application. All the variables were continuous in type and hence were summarized as means and standard deviations.

Normality of data was assessed using the Shapiro–Wilk test, which found that the data were normal. Considering the continuous nature and normal distribution of data, inferential statistics were performed using parametric tests of significance.

Inferential statistics were performed using the Chi-square test, one-way ANOVA, along with post hoc Tukey test and paired t-test. Chi-square test was used to compare categorical data. Comparison of >2 independent means was done using the one-way ANOVA test. Post hoc Tukey test was used to perform post hoc pairwise comparison. The paired t-test is used to compare two related means. The level of statistical significance was set at p < 0.05.

Results

Eighty-eight subjects in the 4–11 years age group requiring restorative treatment in their first visit were selected from the respective OPD as per the inclusion criteria of the present study.

Intragroup Comparisons

Table 1 shows the intragroup comparison of the different parameters used in this study, among the subjects of group I (i.e., audio distraction). All the parameters reduced significantly from pretreatment to posttreatment, except SpO₂, which increased significantly from pretreatment to posttreatment.

Table 1:

Intragroup comparison of various parameters among subjects of group I (audio distraction)

Parameters		Mean	n	Std deviation	p-value
RMS-PS	Pre	3.18	22	0.91	< 0.001 [S]
	Post	1.36	22	0.49
Pulse rate	Pre	92.09	22	8.05	< 0.001 [S]
	Post	84.27	22	6.30
SpO2	Pre	94.77	22	1.63	< 0.001 [S]
	Post	98.32	22	0.72
Systolic BP	Pre	124.27	22	12.94	< 0.001 [S]
	Post	113.05	22	8.52
Diastolic BP	Pre	82.23	22	5.08	< 0.001 [S]
	Post	76.55	22	4.00
Cortisol	Pre	0.0006	22	0.0001	0.001 [S]
	Post	0.0005	22	0.0002
α-amylase	Pre	40.62	22	4.30	< 0.001 [S]
	Post	33.96	22	3.33
IgA	Pre	183.85	22	55.54	< 0.001 [S]
	Post	134.64	22	33.96

S, Significant

Table 2 shows the intragroup comparison of different study parameters among subjects of group II (i.e., aromatherapy). Mean RMS-PS, pulse rate, SpO₂, and diastolic BP changed significantly from pretreatment to posttreatment. However, the other parameters (i.e., systolic BP, salivary cortisol, α-amylase, and IgA) did not change significantly.

Table 2:

Intragroup comparison of various parameters among subjects of group II (aromatherapy)

Parameter		Mean (Unit)	n	Std deviation	p-value
RMS-PS	Pre	3.14	22	0.71	< 0.001 [S]
	Post	2.09	22	0.81
Pulse rate	Pre	110.50	22	17.95	0.018 [S]
	Post	106.95	22	17.17
SpO2	Pre	96.73	22	1.58	0.018 [S]
	Post	97.64	22	1.29
Systolic BP	Pre	120.59	22	18.85	0.166 [NS]
	Post	123.68	22	14.09
Diastolic BP	Pre	82.86	22	6.76	0.008 [S]
	Post	81.64	22	5.53
Cortisol	Pre	0.0004	22	0.0003	0.172 [NS]
	Post	0.0005	22	0.0002
α-amylase	Pre	21.72	22	3.02	0.078 [NS]
	Post	20.71	22	4.63
IgA	Pre	304.92	22	149.33	0.743 [NS]
	Post	299.77	22	141.94

S, significant; NS, not significant

Table 3 shows the intragroup comparison of the different parameters in the clown therapy group. Mean systolic BP, α-amylase, and IgA levels increased significantly from pretreatment to posttreatment, while the rest of the parameters (i.e., RMS-PS scores, pulse rate, diastolic BP, SpO₂, and salivary cortisol) did not change significantly.

Table 3:

Intragroup comparison of various parameters among subjects of group III (clown therapy)

Parameters		Mean	n	Std deviation	p-value
RMS-PS	Pre	2.77	22	0.75	0.329 [NS]
	Post	2.59	22	0.91
Pulse rate	Pre	119.73	22	13.68	0.172 [NS]
	Post	123.77	22	14.72
SpO2	Pre	96.82	22	1.26	0.219 [NS]
	Post	96.27	22	1.70
Systolic BP	Pre	117.23	22	9.85	0.014 [S]
	Post	120.59	22	12.01
Diastolic BP	Pre	83.00	22	4.33	0.311 [NS]
	Post	83.77	22	4.50
Cortisol	Pre	0.0004	22	0.0002	0.789 [NS]
	Post	0.0004	22	0.0002
α-amylase	Pre	75.06	22	35.84	0.035 [S]
	Post	77.79	22	35.23
IgA	Pre	137.30	22	33.89	0.039 [S]
	Post	139.99	22	33.01

S, significant; NS, not significant

Table 4 shows the intragroup comparison of different study parameters in group IV (control group). Mean systolic and diastolic blood pressure increased significantly from pretreatment to posttreatment, while the rest of the parameters (i.e., RMS-PS scores, pulse rate, SpO₂, salivary cortisol, α-amylase, and IgA) did not change significantly.

Table 4:

Intragroup comparison of various parameters among subjects of group IV (control)

Parameters		Mean	n	Std deviation	p-value
RMS-PS	Pre	2.91	22	0.81	0.069 [NS]
	Post	2.59	22	1.01
Pulse rate	Pre	120.64	22	18.27	0.601 [NS]
	Post	122.00	22	17.09
SpO2	Pre	96.32	22	1.59	0.817 [NS]
	Post	96.23	22	1.63
Systolic BP	Pre	119.36	22	12.35	0.003 [S]
	Post	123.23	22	11.60
Diastolic BP	Pre	80.23	22	4.10	0.034 [S]
	Post	81.36	22	4.49
Cortisol	Pre	0.29	22	0.65	0.923 [NS]
	Post	0.28	22	0.63
α-amylase	Pre	71.90	22	37.89	0.104 [NS]
	Post	75.86	22	36.08
IgA	Pre	228.78	22	140.70	0.113 [NS]
	Post	234.17	22	137.66

S, significant; NS, not significant

Intergroup Comparisons

Table 5 shows the intergroup comparison of mean RMS-PS scores at pre- and postintervention. At preintervention, no statistically significant difference was found among the four study groups. While at postintervention, overall, a statistically significant difference was found among the study groups. Post hoc pairwise comparison showed that the mean RMS-PS of group I was found to be significantly lower than that among the rest of the other three study groups. Also, an intergroup comparison of the mean absolute change in the RMS-PS score. Overall, a statistically significant difference was found among the four study groups. Post hoc pairwise comparisons showed that the mean absolute change was found to be maximum in group I, which was significantly higher than that in group II, which was further significantly higher than that in groups III and IV.

Table 5:

Intergroup comparison of mean RMS-PS scores at pre- and postintervention along with intergroup comparison of absolute change in mean RMS-PS scores

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	3.18	0.91	2.78	3.58	0.285 [NS]	NA
	Group II	22	3.14	0.71	2.82	3.45
	Group III	22	2.77	0.75	2.44	3.11
	Group IV	22	2.91	0.81	2.55	3.27
Posttreatment	Group I	22	1.36	0.49	1.15	1.58	< 0.001 [S]	Group I < Group II, Group III, Group IV
	Group II	22	2.09	0.81	1.73	2.45
	Group III	22	2.59	0.91	2.19	2.99
	Group IV	22	2.59	1.01	2.14	3.04
Change from pre- to postintervention	Group I	22	1.82	0.85	1.44	2.20	< 0.001 [S]	Group I > Group II > Group III, Group IV
	Group II	22	1.05	0.65	0.76	1.34
	Group III	22	0.18	0.85	-0.20	0.56
	Group IV	22	0.32	0.78	-0.03	0.66

S, significant; NS, not significant

Table 6 shows the intergroup comparison of mean pulse rate at pre- and postintervention. At preintervention, a statistically significant difference existed in the mean pulse rate of the four study groups. Post hoc pairwise comparisons showed that at preintervention, the mean pulse rate of group I was significantly lower than that among the remaining three study groups. While at postintervention, the mean pulse rate of group I was found to be significantly lower than that of group II, which was further significantly lower than that of groups III and IV. Moreover, intergroup comparison of mean absolute change in pulse rate showed a statistically significant difference. Post hoc pairwise comparisons showed that the mean absolute change was found to be maximum in group I, which was significantly higher than that of group II, which was further significantly higher than that of groups III and IV.

Table 6:

Intergroup comparison of mean pulse rate at pre- and postintervention along with intergroup comparison of absolute change in mean pulse rate

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	92.09	8.05	88.52	95.66	< 0.001 [S]	Group I < Group II, Group III, Group IV
	Group II	22	110.50	17.95	102.54	118.46
	Group III	22	119.73	13.68	113.66	125.79
	Group IV	22	120.64	18.27	112.54	128.74
Posttreatment	Group I	22	84.27	6.30	81.48	87.06	< 0.001 [S]	Group I < Group II < Group III, Group IV
	Group II	22	106.95	17.17	99.34	114.57
	Group III	22	123.77	14.72	117.25	130.30
	Group IV	22	122.00	17.09	114.42	129.58
Change from pre- to postintervention	Group I	22	7.82	8.87	3.89	11.75	0.002 [S]	Group I > Group II > Group III, Group IV
	Group II	22	3.55	6.50	0.66	6.43
	Group III	22	−4.05	13.42	−9.99	1.90
	Group IV	22	−1.36	12.03	−6.70	3.97

S, significant; NS, not significant

Table 7 depicts the intergroup comparison of mean SpO₂ at pre- and postintervention. At preintervention, a statistically significant difference existed in the mean SpO₂ of the four study groups. Post hoc pairwise comparisons using Tukey's test showed that at preintervention, mean SpO₂ of group I was significantly lower than that among the remaining three study groups. While at postintervention, the mean SpO₂ of group I was found to be significantly higher than that of group II, which was further significantly higher than that of groups III and IV. Intergroup comparison of mean absolute change in SpO₂ was done using one-way ANOVA test. Overall, a statistically significant difference was found. Post hoc pairwise comparisons showed that mean absolute change was found to be maximum in group I, which was significantly higher than that of group II, which was further significantly higher than that of groups III and IV.

Table 7:

Intergroup comparison of mean SpO₂ at pre- and postintervention along with intergroup comparison of absolute change in mean SpO₂

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	94.77	1.63	94.05	95.50	< 0.001 [S]	Group I < Group II, Group III, Group IV
	Group II	22	96.73	1.58	96.03	97.43
	Group III	22	96.82	1.26	96.26	97.38
	Group IV	22	96.32	1.59	95.62	97.02
Posttreatment	Group I	22	98.32	0.72	98.00	98.64	< 0.001 [S]	Group I > Group II > Group III, Group IV
	Group II	22	97.64	1.29	97.06	98.21
	Group III	22	96.27	1.70	95.52	97.02
	Group IV	22	96.23	1.63	95.50	96.95
Change from pre- to postintervention	Group I	22	−3.55	1.47	−4.20	−2.89	0.002 [S]	Group I > Group II, Group III, Group IV
	Group II	22	−0.91	1.66	−1.64	−0.17
	Group III	22	0.55	2.02	−0.35	1.44
	Group IV	22	0.09	1.82	−0.72	0.90

S, significant; NS, not significant

Table 8 shows the intergroup comparison of mean systolic blood pressure at pre- and postintervention. At preintervention, no statistically significant difference existed in mean systolic blood pressure of the four study groups. While at postintervention, the mean systolic blood pressure of group I was found to be significantly lower than that of the other three groups. Also, intergroup comparison of mean absolute change in systolic blood pressure. Overall, a statistically significant difference was found. Post hoc pairwise comparisons showed that mean absolute change was found to be maximum in group I, which was significantly higher than that of the other three groups.

Table 8:

Intergroup comparison of mean systolic blood pressure at pre- and postintervention along with intergroup comparison of absolute change in mean systolic blood pressure

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	124.27	12.94	118.54	130.01	0.400 [NS]	NA
	Group II	22	120.59	18.85	112.23	128.95
	Group III	22	117.23	9.85	112.86	121.59
	Group IV	22	119.36	12.35	113.89	124.84
Posttreatment	Group I	22	113.05	8.52	109.27	116.82	0.012 [S]	Group I < Group II, Group III, Group IV
	Group II	22	123.68	14.09	117.43	129.93
	Group III	22	120.59	12.01	115.26	125.92
	Group IV	22	123.23	11.60	118.09	128.37
Change from pre- to postintervention	Group I	22	11.23	8.71	7.37	15.09	< 0.001 [S]	Group I > Group II, Group III, Group IV
	Group II	22	−3.09	10.10	−7.57	1.39
	Group III	22	−3.36	5.92	−5.99	−0.74
	Group IV	22	−3.86	5.48	−6.29	−1.43

S, significant; NS, not significant

Table 9 shows the intergroup comparison of mean diastolic blood pressure at pre- and postintervention. At preintervention, no statistically significant difference existed in the mean diastolic blood pressure of the four study groups. While at postintervention, the mean diastolic blood pressure of group I was found to be significantly lower than that of the other three groups. Intergroup comparison of mean absolute change in diastolic blood pressure shows an overall statistically significant difference. Post hoc pairwise comparisons showed that the mean absolute change was found to be maximum in group I, which was significantly higher than those of groups II, III, and IV.

Table 9:

Intergroup comparison of mean diastolic blood pressure at pre- and postintervention along with intergroup comparison of absolute change in mean diastolic blood pressure

		n	Mean	Std. deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	82.2273	5.07967	79.9751	84.4795	0.265 [NS]	NA
	Group II	22	82.8636	6.76331	79.8650	85.8623
	Group III	22	83.0000	4.33150	81.0795	84.9205
	Group IV	22	80.2273	4.10495	78.4072	82.0473
Posttreatment	Group I	22	76.5455	3.99675	74.7734	78.3175	< 0.001 [S]	Group I < Group II, Group III, Group IV
	Group II	22	81.6364	5.53384	79.1828	84.0899
	Group III	22	83.7727	4.50325	81.7761	85.7694
	Group IV	22	81.3636	4.48856	79.3735	83.3538
Change from pre- to postintervention	Group I	22	5.6818	4.35766	3.7497	7.6139	< 0.001 [S]	Group I > Group II, Group III, Group IV
	Group II	22	1.2273	1.95014	0.3626	2.0919
	Group III	22	−0.7727	3.49056	−2.3204	0.7749
	Group IV	22	−1.1364	2.35626	−2.1811	−0.0917

S, significant; NS, not significant

Table 10 shows the intergroup comparison of mean salivary cortisol levels before and after intervention. At baseline, a statistically significant difference existed in the mean salivary cortisol levels of the four study groups. The mean cortisol levels of groups I, II, and III were found to be significantly lower than those of group IV participants. At postintervention, a statistically significant difference was also found in the mean salivary cortisol levels. The mean salivary cortisol levels of groups I, II, and III were found to be significantly lower than those of group IV. Intergroup comparison of mean absolute change in salivary cortisol levels showed that the difference in mean absolute changes in its levels could not reach the level of statistical significance.

Table 10:

Intergroup comparison of mean salivary cortisol at pre- and postintervention along with intergroup comparison of absolute change in mean salivary cortisol levels

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	0.0005968	0.00014907	0.0005307	0.0006629	0.007 [S]	Group I, Group II, Group III < Group IV
	Group II	22	0.0004286	0.00027550	0.0003065	0.0005508
	Group III	22	0.0004382	0.00015029	0.0003715	0.0005048
	Group IV	22	0.2886832	0.64808157	0.0013399	0.5760265
Posttreatment	Group I	22	0.0004991	0.00016547	0.0004257	0.0005725	0.007 [S]	Group I, Group II, Group III < Group IV
	Group II	22	0.0005082	0.00022861	0.0004068	0.0006095
	Group III	22	0.0004477	0.00016044	0.0003766	0.0005189
	Group IV	22	0.2820855	0.63468277	0.0006829	0.5634880
Change from pre- to postintervention	Group I	22	0.0001	0.00012	0.0000	0.0002	0.999 [NS]	NA
	Group II	22	−0.0001	0.00026	−0.0002	0.0000
	Group III	22	0.0000	0.00017	−0.0001	0.0001
	Group IV	22	0.0066	0.31455	−0.1329	0.1461

S, significant; NS, not significant

Table 11 depicts the intergroup comparison of mean salivary α-amylase levels at pre- and postintervention. At baseline, a statistically significant difference existed in mean α-amylase levels of the four study groups. The mean amylase levels of group II were found to be lower than those of groups I and III, which were further significantly lower than those of group IV. At postintervention, a statistically significant difference was found in the mean α-amylase levels. The mean α-amylase levels of group II were found to be lower than those of groups I and III, which were further significantly lower than those among group IV participants. Intergroup comparison of the mean absolute change in α-amylase levels showed that the difference in mean absolute changes in α-amylase levels among the four study groups was statistically significant. Post hoc pairwise comparisons showed that the mean absolute change was found to be maximum in group I, which was significantly higher than that of group II, which was in turn significantly higher than that of groups III and IV.

Table 11:

Intergroup comparison of mean salivary α-amylase at pre- and postintervention, along with intergroup comparison of absolute change in mean salivary α-amylase levels

		n	Mean	95% Confidence interval for mean			p-value	Post hoc pairwise comparison
				Std deviation	Lower bound	Upper bound
Pretreatment	Group I	22	40.6241	4.29806	38.7184	42.5297	< 0.001 [S]	Group II < Group I < Group III, Group IV
	Group II	22	21.7214	3.02072	20.3821	23.0607
	Group III	22	75.0568	35.84106	59.1658	90.9479
	Group IV	22	71.9002	37.89085	55.1004	88.7001
Posttreatment	Group I	22	33.9618	3.32533	32.4875	35.4362	< 0.001 [S]	Group II < Group I < Group III, Group IV
	Group II	22	20.7132	4.63088	18.6600	22.7664
	Group III	22	77.7941	35.22557	62.1759	93.4122
	Group IV	22	75.8597	36.07808	59.8636	91.8559
Change from pre- to postintervention	Group I	22	6.6623	2.58777	5.5149	7.8096	< 0.001 [S]	Group I > Group II > Group III, Group IV
	Group II	22	1.0082	2.55422	−0.1243	2.1407
	Group III	22	−2.7373	5.69187	−5.2609	−0.2136
	Group IV	22	−3.9595	10.93637	−8.8084	0.8894

S, significant; NS, not significant

Table 12 depicts the intergroup comparison of mean IgA at pre- and postintervention. At baseline, a statistically significant difference existed in the mean IgA levels of the four study groups. The mean IgA levels of group III were found to be lower than those of group I, which was significantly lower than that of group IV, which was further significantly lower than that of group II. Postintervention also, a statistically significant difference was found in the mean IgA levels. The mean IgA levels of groups I and III were found to be lower than of groups II and IV. Intergroup comparison of the mean absolute change in IgA levels shows that overall, the difference in mean absolute changes in IgA levels among the four study groups was statistically significant. Post hoc pairwise comparisons showed that the mean absolute change was found to be maximum among group I, which was significantly higher than that in groups II, III, and IV.

Table 12:

Intergroup comparison of mean immunoglobulin A at pre- and postintervention, along with intergroup comparison of absolute change in mean IgA

		n	Mean	Std deviation	95% Confidence interval for mean		p-value	Post hoc pairwise comparison
					Lower bound	Upper bound
Pretreatment	Group I	22	183.8541	55.54049	159.2288	208.4794	< 0.001 [S]	Group III < Group I < Group IV < Group II
	Group II	22	304.9241	149.33188	238.7140	371.1341
	Group III	22	137.2973	33.88842	122.2720	152.3226
	Group IV	22	228.7777	140.69546	166.3969	291.1586
Posttreatment	Group I	22	134.6382	33.96279	119.5799	149.6964	< 0.001 [S]	Group I, Group III < Group II, Group IV
	Group II	22	299.7650	141.94154	236.8316	362.6984
	Group III	22	139.9886	33.00579	125.3547	154.6226
	Group IV	22	234.1736	137.65743	173.1398	295.2075
Change from pre- to postintervention	Group I	22	49.2159	33.11559	34.5333	63.8985	< 0.001 [S]	Group I > Group II, Group III, Group IV
	Group II	22	5.1591	72.82748	−27.1308	37.4490
	Group III	22	−2.6914	5.74220	−5.2373	−0.1454
	Group IV	22	−5.3959	15.28805	−12.1743	1.3824

S, significant; NS, not significant

Discussion

In its 1991–1992 Guidelines for behavior control, the American Academy of Pediatric Dentistry (AAPD) approved eleven behavior control techniques. The last three techniques include pharmacological therapies like conscious sedation and general anesthesia, while the hand-over-mouth exercise (HOME) and physical restraint were also mentioned in this list. Two decades ago, the dentistry clinic's use of these conventional behavior control approaches was widely accepted and unquestioned. However, societal and professional views on managing child behavior have changed dramatically over the course of time. Today, there is increased scrutiny by both parents and dentists because the traditional behavioral techniques do not always work with all children. As a result, many dentists are interested in additional noninvasive, acceptable alternatives.¹⁴

Distraction has been found to be an effective behavior control strategy for pediatric patients and to be beneficial when administering dental care. All cultures have music as a part of their creative art form. Changes in body temperature, respiration rate, and joyous sensations are just a few of the many health benefits it offers.⁵ Another noninvasive nonpharmacological method of behavior modification and eradication of dental fear and anxiety is aromatherapy, which is already used as an adjuvant in medical practice.

Yet another alternate method, which is easily viable and devoid of the limitations mentioned above, is clown therapy; it is fairly common in hospitals but was never really considered in the field of dentistry. According to Tevatia et al., a clown is a performer whose purpose is to entertain. Clowns are thought to possess the talent of humor. The ability to heal has, however, now broadened in the context of healthcare systems.⁹

Results of the present study show that upon performing intragroup comparison of the various parameters used in this study, among the subjects of group I (i.e., audio distraction), all the parameters reduced significantly from pretreatment to posttreatment, except SpO₂, which increased significantly from pretreatment to posttreatment.

These outcomes were in accordance with those of studies performed by De Silva et al., Alkahtani et al., and Sogabe et al.^5,15,16 As stated by De Silva et al., the reason for better levels of anxiety reduction in the audio distraction group can be attributed to the fact that the audio distraction group may have been more distracted by the music, which may have augmented the effects of the administered sedation and analgesia in their study.¹⁵ At the end of their study, Alkahtani et al. emphasized that music lowers anxiety by introducing pleasant feelings and eliminating negative ones. Through direct neurological reduction of pain, music may enhance analgesic response during dental treatment. Intracerebral endorphins are released during music listening, which helps patients divert their attention from unpleasant stimuli.⁵ Sogabe et al. in their study, also found that blood pressure in the audio distraction group improved significantly, and their results suggested that distraction suppresses vital sign elevation at baseline, during intervention, and after its completion.¹⁶

However, there also exist studies that found contradictory results; such as those performed by Shekhar et al. and Janthasila et al.^17,18 Shekhar et al. at the end of their study found that in comparison to traditional basic behavior guidance techniques such as verbal positive reinforcement and effective communication with euphemisms, without distraction, the use of audiovisual eyeglass distraction during local anesthetic administration does not significantly ameliorate behavior or reduce dental anxiety and pain levels. They added that the reason for this was that distraction tactics focus the child's attention through visual and/or aural stimuli, which in turn activate the nervous system's emotional and cognitive centers, producing feelings of relaxation and happiness. While communication with the dentist is possible, the child's operating environment is somewhat blocked. The youngster may develop a fear of the unknown as a result of their inability to see, hear, or interact with the outside world.¹⁷ In another study performed by Janthasila et al., the authors discovered that aromatherapy and music together were more successful than music alone at reducing anxiety and fear of dental procedures in children, and a single method alone is insufficient to achieve this goal.¹⁸

An intragroup comparison of the different study parameters among subjects of group II (i.e., aromatherapy) also shows that the mean RMS-PS scores, pulse rate, SpO₂, and diastolic BP values changed significantly from pretreatment to posttreatment. However, the values of systolic BP, salivary cortisol, α-amylase, and IgA did not change significantly.

These observations were in line with those of Karimzadeh et al., Nirmala et al., Purohit et al., and Alkanan et al., who found that aromatherapy can diminish anxiety and pain experienced in a dental setting.^6,19–21 Nirmala et al. explained that this is because aromatherapy is thought to offer therapeutic benefits because of the physiological impacts of the volatile molecules inhaled, as well as the mental effects of the fragrance, the latter of which acts through the olfactory system and may have a physiological effect.¹⁹ Purohit et al., in their systematic review, further added that apart from providing an ambient odor, aromatherapy can provide respiratory decongestion, disinfection, and other psychological benefits, thus comforting the patient/recipient, besides causing anxiolysis alone. As previously stated, scents have an impact on the limbic system of the brain as they enter the brain. This system is linked to cardiovascular and respiratory functions, stress, memory, hormonal, and emotional balance. It can therefore have a subtle yet comprehensive effect on the entire body.²⁰ More specifically, for lavender essential oil aroma (used in our study), Karimzadeh et al. stated that by influencing the neurological system, lavender suppresses the action of the hypothalamus, hypophysis, and adrenal glands, which lowers cortisol output and raises serotonin secretion.²¹ This was further explained by Alkanan et al., who stated that among linalyl acetate and linalool, the primary components of Lavandula angustifolia essential oil employed in their study to increase patients' sense of smell, linalool serves as a relaxant and elevates the recipient's mood by inducing the brain to release more serotonin, while linalyl acetate is a narcotic that aids in behavior management. Because both ingredients have anxiolytic properties, lavender oil helps people feel less anxious.⁶

However, these results were contradictory to the outcomes of studies performed by Nord et al., Ndao et al., and James et al.^22–24 The results of the study performed by Nord et al. indicated that ginger and lavender essential oils could not significantly provide comfort to the children in a peri-anesthesia setting. As such, they added that aromatherapy interventions should not be introduced casually.²² Ndao et al. also showed in their double-blind, placebo-controlled trial that aromatherapy was ineffective in lowering anxiety or pain in children and adolescents undergoing stem cell infusion. They opined that this could be due to individual scent preferences and age.²³ James et al. in their study, also found that between aromatherapy and music distraction, the latter showed better results with a relatively greater reduction in pulse rate and respiratory rate, and a meager elevation in oxygen saturation levels.²⁴

Results also show that in the intragroup comparison of the different parameters in group III (clown therapy), the mean systolic BP, α-amylase, and IgA levels increased significantly from pretreatment to posttreatment, while the rest of the parameters (i.e., RMS-PS scores, pulse rate, diastolic BP, SpO₂, and salivary cortisol) did not.

Our results are in accordance with those found in the studies performed by Cosi et al., and Dionigi et al.^25,26 Cosi et al. at the end of their study, found that clowns have the ability to lower anxiety in children, which they believed is because their activities improved the enthusiasm and the willingness of the patients in the waiting room, thus allowing them to collaborate.²⁵ Dionigi et al. further added that when clown doctors and the general population were examined for comic style differences in their study, the results revealed that clowns scored much higher on fun, gracious humor, and lower on cynicism than nonclowns. Thus, their findings were consistent with the function of clowns in medical settings, where they must entertain the audience—typically nervous patients—by using affiliative and constructive kinds of humor. Furthermore, one of the main goals of clown doctors is to deal with challenging circumstances, and in these instances, humor can be a helpful coping mechanism.²⁶

However, the results of our study were in contrast to those performed by Dionigi et al., Tevatia et al., and Efrat-Triester et al.^27–29 Dionigi et al. in their study found that clown intervention, though useful to deal with anxiety in children, did not reduce parental anxiety, which they hypothesized could be due to the fact that clowns were more focused on children.²⁷ Similar outcomes were found by Efrat-Triester et al. when it came to managing anxiety among adult patients with the help of clowns, which they proposed might originate from the general critical mindset and attitude that adults might hold regarding clowns.²⁸ Furthermore, Tevatia et al. added that the newfangled environment of medical clowning, according to therapeutic clowns, is a subtle approach because it operates in a state of constant stress where the patient needs to be soothed using both therapeutic vision and the conventional clown's skills, intuition, and sensitivity. They are making progressively more involved and psychologically complex efforts, while their responsibilities grow from being that of a humorous entertainment to becoming a vital member of the paramedical team.²⁹

Considering intergroup comparison of the various parameters used in this study, it was found that audio distraction performed better by decreasing the mean levels of the RMS-PS score, pulse rate, systolic and diastolic blood pressures, salivary α-amylase and salivary IgA levels, and by increasing the mean oxygen saturation levels following the intervention, relative to preintervention. Also, these changes were statistically significant. However, the change in the levels of mean salivary cortisol was not statistically significant among any of the four groups.

This can be attributed to several factors discussed above. Subjects of the audio distraction group may have been more distracted by the music, which might have further augmented the effects of the administered sedation and analgesia in their study.¹⁵ A rising volume of research supports the use of music in the clinical context, either in addition to or instead of conventional therapies, since it affects the biological and psychological aspects of anxiety.³⁰

Aromatherapy in our study was relatively less effective in reducing anxiety among children, which could be due to individual scent preferences and age.²³ Even when used properly, essential oils are considered to pose few dangers to patients, but there are always certain precautions to be taken before/during use, such as consultation of a reputable and experienced practitioner, proper storage of essential oil vials, usage of predetermined and properly measured volumes of essential oils, etc.²²

Moreover, though the use of clowns in medical and dental settings has resurfaced in recent times, it seems like this method, aimed at anxiolysis and behavior management, has still not been completely accepted by young patients. Medical/dental clowns are not yet widely common in India, but there is a growing interest in their potential benefits. To the best of our knowledge, this is among the first studies that investigated and compared the psychological, hemodynamic, and salivary changes in children during noninvasive restorative treatment using the three different behavior modification techniques (i.e., audio distraction, aromatherapy, and clown therapy) discussed above.

There are some limitations that need to be acknowledged. Apart from the few confounding factors of the parameters used (mentioned above), the study required a prolonged time with each subject, which is attributed to the collection of samples of unstimulated saliva and measurements of multiple parameters (both before as well as after intervention) after the parent/guardian and child understood and signed the consent. The relatively small sample size may also have affected the results of the study. Moreover, at least the hemodynamic parameters were not monitored throughout the whole procedure, which otherwise would have allowed better and more precise evaluation of the changes in anxiety levels. Despite these limitations, this clinical investigation was carried out by one trained single examiner, and the study used both psychological as well as physiological parameters to assess dental anxiety, ensuring its validity and reliability.

Conclusion

Hence, to conclude, audio distraction relatively outperformed aromatherapy and clown therapy at reducing anxiety levels among youngsters visiting the dental office for their first visit. Since the first dental visit has a crucial role to play in all subsequent encounters of children with the dentist, there always exists a need to put in greater emphasis and conduct more of such studies comparing other contemporary, noninvasive, nonpharmacological behavior management techniques too, to deal with dental fear and anxiety, thus achieving the goal of anxiolysis.

Clinical Significance

By integrating subjective, physiological, and biochemical data, this study not only enhances the reliability of anxiety assessment but also offers practical insight into the clinical efficacy of these behavior management techniques. The results have the potential to guide pediatric dentists in selecting evidence-based, patient-friendly approaches to behavior guidance, thereby improving the overall quality of care, reducing appointment durations, and fostering a more positive dental experience for children.

Orcid

Mukesh Kumar Dey https://orcid.org/0009-0001-1533-0534

Kavita Dhinsa https://orcid.org/0000-0002-3597-787X

Gunjan Yadav https://orcid.org/0000-0001-9495-9471

Sonali Saha https://orcid.org/0000-0001-5361-1698

Amit Rai https://orcid.org/0000-0002-5270-0303