ORIGINAL RESEARCH |
https://doi.org/10.5005/jp-journals-10077-3299 |
Assessing Behavior and Anxiety among 3–9-year-old Children during Local Anesthesia Administration Using Conventional and Camouflaged Syringes: A Randomized Split-mouth Design
1–6Department of Pedodontics and Preventive Dentistry, Vinayaka Mission’s Sankarachariyar Dental College, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, India
Corresponding Author: Veena Arali, Department of Pedodontics and Preventive Dentistry, Vinayaka Mission’s Sankarachariyar Dental College, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, India, Phone: +91 7760748787, e-mail: pedo.veena@gmail.com
Received: 19 February 2024; Accepted: 15 March 2024; Published on: 27 April 2024
Aim and background: Childhood dental fear often stems from painful stimuli and heightened pain perception. Needles, perceived as threatening instrument, triggers anxiety, exacerbating pain memory. Camouflaged syringes, shaped like toy alligators, conceal the instrument alleviating children’s anxiety. This study aims to evaluate whether camouflaged syringes compared to conventional syringes have a favorable impact on the behavior and anxiety levels of the children according to variations in pulse rates, Face, Legs, Activity, Cry, Consolability (FLACC) behavior pain scale and facial image scale (FIS). Materials and methods: The study included 60 children divided into two age-groups (3–6 years and 6–9 years). It was also registered in Clinical Trials Registry, India (CTRI) as a prospective study with CTRI number CTRI/2023/08/056189. Conventional syringes were used in the first appointment, and camouflaged syringes in the second, employing a split-mouth design. Prior to block administration, a topical anesthetic gel was applied. Pulse rates were noted before and during the block administrations using a pulse oximeter. Behavior was evaluated by the FLACC scale before and during the administration of local anesthesia (LA). After the injection, children were expressed their anxiety during the block administration using FIS. Paired sample t-tests were used for (p ≤ 0.05) assessing significant differences in bivariate samples. Results: In 3–6-year-olds, camouflaged syringes significantly improved FLACC pain scale and reduced anxiety according to FIS during LA, positively impacting children’s behavior. Conclusion: Camouflaged syringes have a positive impact on children’s behavior, especially in the 3–6-year-old age-group where cognitive abilities are limited. They enhance distraction, effectively reducing anxiety levels. How to cite this article: Rajan RE, Gunasekaran S, Arali V, et al. Assessing Behavior and Anxiety among 3–9-year-old Children during Local Anesthesia Administration Using Conventional and Camouflaged Syringes: A Randomized Split-mouth Design. J South Asian Assoc Pediatr Dent 2024;7(1):21–26. Source of support: Nil Conflict of interest: NoneABSTRACT
Keywords: Behavior management, Dental anxiety, Distraction technique, Local anesthesia, Pediatric dentistry
INTRODUCTION
Fear and anxiety about dentists and dental procedures are common among pediatric patients.1 Fear is generally considered to be a person’s reaction to a real threat to their lives or to a dangerous circumstance.2 Anxiety is an emotional condition that sometimes cannot be distinguished before the actual interaction with the dangerous stimulus. Dental anxiety is the terminology used to characterize a patient’s unique reaction to the stress associated with obtaining dental care when the stimulus is ambiguous, vague, or absent at the moment.3 Pain or the fear of pain can play a major part in dental anxiety, which is an important issue for dental professionals since it may discourage children from getting dental care and make the atmosphere unpleasant and uncooperative for successful treatment.4 Most of it can be related to procedures involving local anesthesia (LA). The dental syringe is perceived as a frightening tool both visually and psychologically, and children get anxious at the sight of a needle, which causes them to feel more pain for longer periods of time and accentuates their perceptions of pain.5 Earlier studies have been conducted with shorter needles, shorter cartridges, thin gauge needles to reduce the pain perception by the patient.6 However, there is only limited number of studies in which the whole injection apparatus is kept out from the sight of children.1 Camouflage syringe makes use of syringe sleeve made of autoclavable plastic shaped like a toy alligator that hides the needle and apparatus from child’s sight. This can serve as an efficient distraction tool while the injection is being administered and can improve behavior of the patient by decreasing dental anxiety. This has a significant effect in the age-group of 3–6 years by positively influencing their behavior as the younger children focuses mainly on the appearance of things due to lack of cognitive development.7
This study aims to evaluate whether camouflaged syringes compared to conventional syringes have a favorable impact on the anxiety and behavior of children depending on the alterations in pulse rate, Face, Legs, Activity, Cry, Consolability (FLACC) behavior pain scale and facial image scale (FIS). This study adopted a null hypothesis as there would be no change between the case and control group.
MATERIALS AND METHODS
Ethical Clearance and Consent
After receiving acceptance from the Institutional Ethics Committee, this randomized, crossover split-mouth study was carried out in the department of pediatric and preventive dentistry, XXXXXX (not disclosed for blinding) (VMSDC/IEC/Approval No. 284) and in accordance with the ethical principles for medical research involving human subjects outlined in the Helsinki Declaration of 1975 (revised 2013). Before the study began, the parents of the children and children in the older age-group (6–9 years) who participated provided written informed consent. It was also registered in Clinical Trials Registry, India (CTRI) as a prospective study with CTRI number CTRI/2023/08/056189.
Sample Size Calculation and Sampling
After the study’s power was set at 80% and the significance level at p < 0.05, the necessary sample size was calculated as 60 with age-group between 3 and 9 years based on the key article by Melwani et al.7 In order to divide children into two age-groups with equal numbers, simple random sampling was done using lottery method where odd numbers were allotted for conventional and even numbers were allotted for camouflaged syringes (groups I and II: 3–6 and 6–9 years, respectively).
Inclusion and Exclusion Criteria
Children having their first dental visit, belonging to Frankel’s positive and definitely positive (rating 3 and 4) and behavior, requiring block administrations for pulpectomy and extractions in primary mandibular teeth in at least two quadrants were included for the study.8 All patients belonging to Frankl’s negative and definitely negative behavior, conditions that required emergency treatment, unpleasant dental experiences in the past, children lacking cooperative behavior and medically compromised patients were not allowed to participate in the study.
Procedural Methodology
For this study, a split-mouth design was employed, with children in each age-group being randomly assigned to one of two groups; group I containing 3–6-year-olds and group II containing 6–9-year-olds with 30 patients in which conventional syringes and camouflaged syringes (Fig. 1) were used respectively in the two consecutive appointments.
Fig. 1: Materials used in the study
The investigator was trained and calibrated in the Department of Pedodontics and Preventive Dentistry, Vinayaka Mission’s Sankarachariyar Dental College, Vinayaka Mission’s Research Foundation (Deemed to be University) to use the FLACC behavior pain scale prior to the start of the study.
Positive reinforcements and tell-show do technique were the behavior management techniques used during the treatment where the camouflaged syringe was mentioned as magic crocodile spilling water to make the tooth sleep. In both appointments, before injecting the local anesthetic, topical anesthetic gel (Xylofrench 2%) was applied for 2 minutes, and a finger pulse oximeter was used to record baseline pulse rate.
Inferior alveolar nerve block injection was then administered using the camouflaged syringe with 27 G needle, and the pulse rate was recorded by a third person. Child’s behavior was graded with the help of FLACC behavior pain scale by the investigator before and during the LA administration.9 After the injection, children were asked to express their anxiety during the LA administration using FIS by pointing out a range of faces varying from very happy to very sad.10
On the subsequent appointment 2 weeks later, nerve blocks were administered for the children with conventional syringe, and all pulse rates, FLACC scale and FIS were recorded as done in the previous visit.
Statistical Analysis
The data collected was tabulated and subjected to statistical analyses using IBM Statistical Package for the Social Sciences (SPSS) Statistics for Windows, version 23.0 (Armonk, New York: IBM Corp). Significant difference of pulse oximeter readings, FLACC scores and FIS were analyzed employing the paired sample t-test, which deemed a probability value (p) ≤ 0.05 to be significant.
RESULTS
Pulse oximeter showed a small decrease in readings while the camouflaged syringe was used in both groups. While using conventional and camouflaged syringes in group I, the pulse rate were 113.20 ± 13.35 bpm and 104.60 ± 15.75 bpm, respectively while in group II, it was 107 ± 18.26 bpm and 98.60 ± 15.10 bpm, respectively. This indicated that child had lower anxiety levels while using camouflaged syringes which was highly statistically significant (p < 0.005) (Fig. 2).
Fig. 2: Pulse oximeter readings obtained in both the groups
Table 1 shows the demographic details of the participants with respect to age, gender, height and weight. When camouflaged syringes were used, the mean FLACC scores in both groups dropped, indicating improved behavior. When conventional and camouflaged syringes were used in group I, the mean FLACC scores were 7.37 ± 2.47 and 3.00 ± 2.09, respectively while that for group II were 6.23 ± 2.45 and 3.80 ± 1.94, respectively (Fig. 3). When using conventional and camouflaged syringes, the p-values after comparing the FLACC scores were both highly statistically significant in groups I and II suggesting an improvement in behavior (p < 0.005) (Tables 2 and 3).
| Demographic details | ||
|---|---|---|
| Variables | 3–6 years | 6–9 years |
| Mean age (in years) | 3.68 ± 1.7 | 7.82 ± 1.89 |
| Gender | ||
| Girls | 15 | 15 |
| Boys | 15 | 15 |
| Mean weight (in kg) | 14.28 ± 1.89 | 21 ± 2.3 |
| Mean height (in cm) | 99 ± 1.92 | 108 ± 1.56 |
The study involved 60 patients, with 15 boys and 15 girls in each group. The mean age of patients was 3.68 ± 1.7 years (3–6 years group) and 7.82 ± 1.89 (6–9 years group)
| Paired differences | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 95% confidence interval of the difference | |||||||||
| Mean | Standard deviation | Standard error mean | Lower | Upper | t | df | p-value | ||
| Pair 1 | PO CON before—PO CAM before | 6.3000 | 14.0545 | 2.5660 | 1.0520 | 11.5480 | 2.455 | 29 | 0.020 |
| Pair 2 | PO CON during—PO CAM during | 8.4000 | 14.3829 | 2.6260 | 3.0293 | 13.7707 | 3.199 | 29 | 0.003 |
| Pair 3 | FLACC CON before—FLACC CAM before | 0.9000 | 1.8819 | 0.3436 | 0.1973 | 1.6027 | 2.619 | 29 | 0.014 |
| Pair 4 | FLACC CON during—FLACC CAM during | 2.4333 | 1.6333 | 0.2982 | 1.8234 | 3.0432 | 8.160 | 29 | 0.0005 |
| Pair 5 | FI CON after—FI CAM after | 0.9333 | 0.7397 | 0.1350 | 0.6571 | 1.2095 | 6.911 | 29 | 0.0005 |
| Paired differences | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 95% confidence interval of the difference | |||||||||
| Mean | Standard deviation | Standard error mean | Lower | Upper | t | df | p-value | ||
| Pair 1 | PO CON before—PO CAM before | 3.1000 | 8.3557 | 1.5255 | –0.0201 | 6.2201 | 2.032 | 29 | 0.051 |
| Pair 2 | PO CON during—PO CAM during | 8.6000 | 11.8978 | 2.1722 | 4.1573 | 13.0427 | 3.959 | 29 | 0.0004 |
| Pair 3 | FLACC CON before—FLACC CAM before | –0.0667 | 2.2273 | 0.4066 | –0.8984 | 0.7650 | –0.164 | 29 | 0.871 |
| Pair 4 | FLACC CON during—FLACC CAM during | 3.0667 | 2.2581 | 0.4123 | 2.2235 | 3.9098 | 7.439 | 29 | 0.0005 |
| Pair 5 | FI CON after—FI CAM after | 1.5333 | 1.1958 | 0.2183 | 1.0868 | 1.9798 | 7.023 | 29 | 0.0005 |
Paired sample tests showed high significance in FLACC scores and FIS during the use of camouflaged syringes in both the age-groups
Fig. 3: Face, Legs, Activity, Cry, Consolability scores obtained in both the groups
An increased percentage of children stated lower anxiety levels by indicating happy face in the FIS after the procedure in both the groups while using camouflaged syringes. The scores were 3.40 ± 1.25 and 1.87 ± 0.68, respectively for group I and 3.30 ± 1.02 and 2.37 ± 0.96 for group II which was highly statistically significant (Fig. 4).
Fig. 4: Facial image scale in both the groups
DISCUSSION
Dental anxiety is a major concern in providing dental treatment that differs patients from getting treatment. Approximately, 14% of children aged 4–11 reported feeling anxious when they visit a dental facility, with injections being their biggest dread.11 In the current study, camouflaged syringes were used so that it can distract the patient by its modified alligator-shaped sleeve that conceals the needle. The 3–6-year-olds were included mainly in the study as this age-group accords with the preoperational stage of Jeans Piaget’s theory and focuses mainly on the appearance of things such that children can be distracted easily. The current study compared pulse rate between the groups before and during the administration of local anesthetic. According to results obtained, pulse rate was maximum during the LA administration.12 This could be due to the anxiety created by the sight of the needle for the first time in children which decreased progressively with time.13
The study employed the FIS due to its ease of use for children as the verbal skills of children in this age-group are often quite limited. The most positive emoji on this scale receives a score of 1, while the most negative emoji receives a score of 5. FLACC behavior pain scale was used in this study as the younger kids may fail to report their level of pain accurately and this scale assesses pain by analyzing five different domains—face, legs, activity, cry, and consolability.
Pulse Rates
Pulse oximeter readings were taken prior and during the administration of LA as an objective measure of anxiety and research indicates that this particular physiological characteristic is more closely associated with dental visit anxiety than other physiological indicators.14 High levels of tension and anxiety related to dental visits are correlated with the increase in pulse rate.15 Yadav et al. discovered that pulse oximeter is a noninvasive, objective method for assessing the physiological alterations brought on by subjective nature of anxiety.16 A study by Rosenberg et al.17 found that anxiety-producing circumstances change physiological markers including pulse rate and blood pressure. When camouflage syringes were used in this study, there was a small drop in pulse rate observed in both groups, suggesting a decreased level of anxiety. The results differ from those of Padminee et al. who found that children aged 6–11 who received their LA with a camouflaged syringe had a significantly higher heart rate (HR) than the group that received normal syringes.18
Face, Legs, Activity, Cry, Consolability Behavior Pain Scale
The FLACC behavior pain scale was originally intended to assess postoperative pain in infants and children between the ages of 2 months and 7 years. The first usage guidelines included spending 1–5 minutes observing the child and comparing the observed behaviors to each item’s description on the scale which includes a range of descriptors and behavioral characteristics that are typically linked to pain.19 It evaluates the level of procedural pain in patients who are nonverbal or preverbal and are unable to self-report their discomfort as in 3–6 year and 6–9-year-olds.20 Melwani et al. assessed in his study that when camouflage syringes were used in 6–11-year-olds, there was a little drop in HR and a decrease in FLACC scores, which indicated reduced anxiety and improved behavior.7 In his study, Ismail et al. discovered that 90% of children found the hydroshooter camouflage syringes more attractive and had reduced FLACC scores.21 A statistically significant difference was likewise discovered by Bagher et al. when a camouflaged syringe was used.22 Ujaoney et al. also strongly recommended using camouflaged syringes to help children who are afraid of the dentist.23 In the current study, using camouflage syringes was associated with poorer FLACC scores; this effect was especially pronounced in children aged 3–6.
Facial Image Scale
The FIS, developed by Buchanan in 2002, is a valid tool used to assess dental anxiety in young children. The FIS consists of five faces, ranging in score from 1 (very sad) to 5 (very cheerful). Children were asked to indicate faces which, at that precise moment, best resembled them. Score 1 is assigned to the face with the greatest negativity on the scale, while 5 is assigned to the face with the highest positivity.24 Fathima et al. also concluded that it is a reliable indicator of dental anxiety and can be used with young patients in a clinical setting and it may be worth considering administering the FIS at different points throughout the dental session.25 According to Muinelo-Lorenzo et al., variations in pulse rate were consistent with variations in the FIS.26 Khokhar et al. also found that children between the ages of 6 and 9 years old had lower anxiety levels following treatment.27 This finding is consistent with the current study. In the current study, FIS was used to assess dental anxiety between the groups at different time intervals and the results showed that the subjects were less anxious at the time of administration of LA which was similar to the study by Beegum et al.10
Distraction in Behavior Management
A child’s fearful or uncooperative behavior can disrupt effective dental treatment. This is where techniques such as tell show do, voice control, nonverbal communication, positive reinforcement, and distraction come in action. Distraction means shifting the child’s attention away to something engaging or interesting.28 In this study, we had used metal aspirating syringes with cartridges as these can be easily used in children with an added advantage of aspiration with one hand and cartridge being visible. These type of metal syringes are also corrosion resistant and autoclavable which is in accordance with American Dental Association (ADA) standards of syringe.29 Camouflaged syringes use a toy alligator sleeve that can conceal the needle rather than the conventional syringes which has the needle in the child’s sight. The literature on using camouflaged syringes to reduce fear and positively affect behavior is extremely sparse. An assessment of the effectiveness of a camouflage sleeve made using cold cure acrylic was done through a clinical evaluation. Consistent with the current study, the results of that study also significantly support the use of camouflaged syringes to minimize dental fear and anxiety in children.17 Two studies were carried out after the needle was shown to the children determine their response to dental injection. Contrary to the current study, which found that the needle concealed in the disguised syringe had a favorable impact on behavior and anxiety, these studies found no impact on children’s reactions when the needle was revealed or hidden.30,31 The camouflaged sleeve distracts the child by making them focus on the shape of the sleeve and not the needle which reduces their anxiety. This could be a new milestone in the field of behavior management in pediatric dentistry as the camouflaged syringes can serve as a solution for LA administration, which is the most terrorizing part of treatment for the child.
Limitations
Only the metal aspirating dental syringe that utilizes disposable needles and cartridges are compatible with Angelus™ sleeve. The sleeve can be difficult to handle due its large size. The sample size of the study was not large enough to draw accurate conclusions regarding the product. For this, further studies should be done on large scale.
Clinical Significance
This study explores innovative methods, such as camouflaged syringes, as a distraction technique to manage anxiety in children and thereby inducing a positive dental experience. The inclusion of different age-groups (3–6 years and 6–9 years) acknowledges the developmental variations in cognitive abilities and attention spans. These findings can help tailor anxiety management techniques based on age-specific needs. The outcomes of this study could pave the way for additional investigation, encouraging exploration into additional strategies for managing dental anxiety in pediatric patients. It could inspire investigations into the development of other child-friendly dental tools or techniques.
CONCLUSION
Dental anxiety has a negative impact on children as well as dental professionals. Camouflaged syringes positively influence the behavior of children and decrease their anxiety in both age-groups. It was easier in the 3–6-year-old age-group as they focus their attention more on how things appear and can be distracted easily. Hence, the null hypothesis predicted in the beginning of the study was dropped. The application of camouflaging syringes can help the clinicians in effectively managing the child in the dental office by alleviating their dental anxiety and providing them with a positive experience.
ORCID
Reshma E Rajan https://orcid.org/0000-0002-0769-1524
Veena Arali https://orcid.org/0000-0002-6614-3405
M Vijayakumar https://orcid.org/0000-0002-9345-9261
Arya A Vargheese https://orcid.org/0000-0002-9159-4443
Yash S Latkar https://orcid.org/0000-0003-0595-2548
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