Dental anxiety in childhood can seriously impact a child’s perception of dentists and greatly diminish the dental experience¹. A majority of dental procedures in children require profound local anesthesia for them to be painless. The irony is that the procedure of LA administration to make treatments painless, itself is associated with pain and related anxiety². Pain and anxiety are often inter-related. Anxious patients are usually less cooperative and experience more pain³, thereby affecting the quality of care provided as well as the overall treatment outcome^4-6. The very sight of needle is what worsens anxiety in children. Also, in India, the parents and the society play an active role in inducing anxiety about injections in a child’s mind⁷. It, thus becomes very challenging for a Paediatric Dentist to alleviate this anxiety.

Behaviour management of the child patient forms the cornerstone in paediatric dentistry. Myriad techniques are described in the literature when it comes to managing the child’s behaviour at the dental office^8,9. These include both pharmacological and non-pharmacological methods. Non-pharmacological methods may include Tell Show Do, desensitization, modelling, reframing, distraction and hypnosis, while pharmacological management involves a broad spectrum of agents administered in a variety of ways (e.g., oral, parenteral, and inhalation routes). The child who requires dental treatment is, frequently, not capable of cooperative behaviour. The challenge that the clinicians face is to provide an environment that allows technically complex dental treatment, starting with the injection of local anesthetic, to be delivered without inflicting adverse psychological or physical harm to the child or others. Administering LA by injection is still the most common method used in dentistry. However, there is a constant search for ways to avoid the invasive and often painful nature of the injection, and to find a more comfortable and pleasant means of producing local anesthesia before dental procedures¹⁰.

Dental anxiety can involve behavioural, cognitive, emotional, and physiological components, and their expression may vary between individuals. Pain perception has a large psychological component based on the amount of attention directed toward the noxious stimulus modulating the pain. Distraction techniques are anxiety-reducing strategies that overload the patient’s limited attention capacity, thus diverting their attention from unpleasant procedures (noxious stimuli). Distraction techniques can be active or passive. Active techniques involve activities that require the direct participation of the child, such as the use of toys and games. Passive techniques rely on the use of music and video and do not require the child to directly participate.

Distraction seems to be a safe and low-cost strategy that can have a positive impact on young individual’s dental fear and anxiety, thus improving the quality of dental care. Knowledge on the effectiveness of distraction techniques may be helpful to increase clinician’s confidence during the management of fearful or anxious children and to assist the practitioner in the improvement of children’s and adolescent’s behaviour and experience during dental care, creating a more pleasant environment for the patient, his/her parents and the paediatric dentist¹¹.

Recently, Dental Syringe Camouflage Technique has gained attention as a Distraction method to reduce needle anxiety in children. There is scarcity of studies conducted to evaluate efficacy of such technique as against the conventional dental syringes. The current study was planned with this background to answer the research question: “How effective shall be camouflaging the dental syringe with a cloth dental syringe sleeve in reducing associated needle anxiety in school going children in dental office?”

Hypothesis: Camouflaged Dental Syringe shall lead to significant reduction of needle related anxiety as compared to use of conventional syringes in school going children during local anesthesia administration.

AIM AND OBJECTIVES:

AIM:

To compare ‘Camouflaged Dental Syringe’ with ‘Conventional Dental Syringe’ for LA administration in reducing needle associated anxiety in school going children in dental office.

OBJECTIVES:

Primary:

·       To compare the effect of ‘Camouflaged Dental Syringe’ with ‘Conventional Dental Syringe’ on Self-reported Dental Anxiety Scores in school going children aged 6-9 years (early mixed dentition period) during local anesthesia administration

·       To compare the effect of ‘Camouflaged Dental Syringe’ with ‘Conventional Dental Syringe’ on Self-reported Pain Scores in school going children aged 6-9 years (early mixed dentition period) during local anesthesia administration

·       To compare the effect of ‘Camouflaged Dental Syringe’ with ‘Conventional Dental Syringe’ on Physiological Parameters of Anxiety (SpO₂, Heart Rate, Blood Pressure) in school going children aged 6-9 years (early mixed dentition period) during local anesthesia administration

Secondary:

·       To compare the effect of Light-coloured with Dark-coloured Camouflaged Dental Syringes on child’s Self-reported Dental Anxiety, Self-reported Pain and Physiological Parameters of Anxiety during the same procedure

MATERIAL AND METHODS:

Study Setting-

The study will be conducted in Post-Graduate Clinic, Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences,
King George’s Medical University, Lucknow, Uttar Pradesh

Study Design:

The research question will be addressed within a randomized clinical trial study design.

Participants:

Children of any gender in the age group 6-9 years, visiting Department of Paediatric and Preventive Dentistry, FODS, KGMU, Lucknow, UP; shall be screened for following inclusion criteria:

Inclusion criteria:

Ø  Patients requiring dental procedures indicated for Inferior Alveolar Nerve Block anesthesia (pulp therapies, extractions, or other surgical interventions)

Ø  Patients categorized under Frankel’s negative and positive behaviour categories

Ø  No history of previous dental office visits

Ø  Patients whose parents give informed consent for participation

Exclusion Criteria-

Ø  Children with special health care needs

Ø  Children showing positive response to patch test of Lignocaine

Ø  Children whose parents/guardian do not agree for written informed consent

Pediatric patients finally fulfilling all inclusion and exclusion criteria shall be enrolled in the study as participants. All participants shall be randomly assigned to one of the following groups-

Group I (Control)- Use of Conventional Dental Syringes for LA administration

Group II (Experimental)- Use of Camouflaged Dental Syringes LA administration with

IIa- Light-coloured Camouflaged Dental Syringe

IIb- Dark-coloured Camouflaged Dental Syringe

Sample size:

Sample Size at 90% Power

Sample size is calculated on the basis of proportion of no pain (according to study score) among two study groups using the formula

Where p₁ = 0.15 (15%) proportion of no pain in first group

p₂ = 0.543 (54.3%) proportion of no pain in second group

(Ref. Savitha Sathyaprasad, Divyia J., Krishna Moorthy S. H., Rakesh Rajeevan Nair, Shashikala Prabhu.Camouflage Technique: A Novel Behaviour Management Strategy For Local Anesthesia)

e = 1.75(p₁- p₂), the attributable risk considered to be clinically significant

Type I error, α=5%

Type II error β=10% for setting power of study 90%

The minimum sample size required n = 38 each group

Randomization:

              A block randomization process shall be followed for allocating participants into control or experimental groups. This involves recruiting participants in short blocks and ensuring that one-half of the participants within each block are allocated to “Group I” and the remaining one half to “Group II” within each block to obtain the different combinations. Blocks of ‘Four’ shall be used to allocate to Group I and II respectively. Within Group II, again blocks of ‘four’ will be created using computer generated sequence to allocate to subgroups.

Procedure:

All participants finally enrolled in the study shall be allocated to Control or Experimental groups. The parent/guardian will be explained about the study in detail in a language well understood by them and written consent to be taken for the same.

A standard set of instructions shall be given to all patients prior to LA administration using euphemisms (Annexure1). Patient will not be informed of the actual procedure to be performed post Local anesthesia administration. A baseline data collection will be done before the intervention.

The intervention will be carried out by a single investigator to avoid procedural and examiner bias. The outcomes shall be measured by different observers. The order of instructions shall be kept identical for all the groups. Use of a topical anesthetic gel will be common for all the groups. A video of each patient during local anesthesia administration will be recorded to note the facial expressions of the patient and sent to observers for evaluation. Finally, post-intervention data collection will be done.

OUTCOMES:

Primary:

Subjective measures: These shall be recorded by asking the patient to choose the most-apt picture in the report card.

Change in anxiety scores using Venham Picture Test both pre and post LA administration

-       Pain perception: Wong-Baker FACES Pain Rating Scale post LA administration

Objective measures: These shall be recorded by an observer other than the one performing the LA administration.

-       Change in Oxygen saturation (SpO2) post-intervention

-       Change in Heart rate post-intervention

-       Change in Blood pressure post-intervention

Secondary:

All Subjective and Objective measures shall be observed and compared within subgroups of Experimental group using Camouflaged Dental Syringes.

DATA COLLECTION:

Data for following variables shall be collected as defined in Outcomes as inter and intra group comparison

-       Change in anxiety scores

-       Wong-Baker FACES Pain Rating scores

-       Change in Oxygen saturation (SpO2) post-intervention

-       Change in Heart rate post-intervention

-       Change in Blood pressure post-intervention

DATA ANALYSIS:

Data will be analyzed and expressed in mean (SD) or proportion/percentage or Median values depending on type of data.

-       Change in anxiety scores: Shall elicit ‘ordinal’/ ‘discrete’ data

-       Wong-Baker FACES Pain Rating scores: Shall elicit ‘ordinal’/ ‘discrete’ data

-       Change in Oxygen saturation (SpO2) post-intervention: shall elicit ‘continuous’ data

-       Change in Heart rate post-intervention: shall elicit ‘continuous’ data

-       Change in Blood pressure post-intervention: shall elicit ‘continuous’ data

The observations between the groups shall be compared with Mann Whitney Test for all discrete/ordinal data. Wilkoxan sign rank test shall be used to compare observations pre and post intervention for all discrete/ordinal data observations. Observations of continuous variables shall also be compared with similar non parametric tests since sample is not being retrieved from a Gaussian population. p-value < 0.05 will be taken as the significance level.

REVIEW OF LITERATURE:

Anjana M Melwani et al.¹² compared the efficacy of a camouflaged syringe and conventional syringe on behaviour and anxiety in 6-11 year old children during local anesthesia administration. They concluded that camouflaged syringes for anesthesia are effective in improving behaviour of children and decreasing their anxiety.

Savitha Sathyaprasad et al.⁷ used a modified syringe pattern camouflaged with the child’s favourite cartoon character and found better management of children when such a method was applied as made evident by their improved Frankel behaviour score.

Monika K. et al.¹³ compared camouflaged and conventional syringes in eliminating dental anxiety and fear in children. They found that fear and anxiety was significantly reduced when camouflaged syringes are used.

Venu Vallakatla et al.¹⁴ compared the effects of conventional and camouflaged syringe in reducing anxiety and pain levels during maxillary dental procedures in paediatric patients. They concluded that the use of camouflaged syringe was associated with improved outcomes related to dental fear and anxiety in children.

References:

1.              Majstorovic, M., D. E. Morse, D. Do, L. l Lim, N. G. Herman, and A. M. Moursi. “Indicators of Dental Anxiety in Children Just Prior to Treatment.” The Journal of Clinical Pediatric Dentistry 39, no. 1 (2014): 12–17.

2.              Davis, M. J., and L. D. Vogel. “Local Anesthetic Safety in Pediatric Patients.” The New York State Dental Journal 62, no. 2 (1996): 32–35.

3.              Dou, Lei, Margaret Maria Vanschaayk, Yan Zhang, Xiaoming Fu, Ping Ji, and Deqin Yang. “The Prevalence of Dental Anxiety and Its Association with Pain and Other Variables among Adult Patients with Irreversible Pulpitis.” BMC Oral Health 18, no. 1 (2018): 1–6.

4.              Al-Khalifa, Khalifa S. “Prevalence of Dental Anxiety in Two Major Cities in the Kingdom of Saudi Arabia.” Saudi Journal of Medicine and Medical Sciences 3, no. 2 (2015): 135.

5.              Al-Madi, Ebtissam M., and HodaAbdelLatif. “Assessment of Dental Fear and Anxiety among Adolescent Females in Riyadh, Saudi Arabia.” Saudi Dent J 14, no. 2 (2002): 77–81.

6.              Gadve, Vandana R., Ramakrishna Shenoi, Vikas Vats, and Amit Shrivastava. “Evaluation of Anxiety, Pain, and Hemodynamic Changes during Surgical Removal of Lower Third Molar under Local Anesthesia.” Annals of Maxillofacial Surgery 8, no. 2 (2018): 247.

7.              Sathyaprasad, Savitha, J. Divyia, S. H. Krishna Moorthy, Rakesh Rajeevan Nair, and Shashikala Prabhu. “Camouflage Technique: a Novel Behaviour Management Strategy for Local Anesthesia,” 2020.

8.              Curtis, Sarah, Aireen Wingert, and Samina Ali. “The Cochrane Library and Procedural Pain in Children: An Overview of Reviews.” Evidence-Based Child Health: A Cochrane Review Journal 7, no. 5 (2012): 1363–99.

9.              Goettems, Marilia Leao, Eduardo Jung Zborowski, Francine dos Santos Costa, Vanessa Polina Pereira Costa, and Dione Dias Torriani. “Nonpharmacologic Intervention on the Prevention of Pain and Anxiety during Pediatric Dental Care: A Systematic Review.” Academic Pediatrics 17, no. 2 (2017): 110–19.

10.           Ram, D., and B. Peretz. “Administering Local Anaesthesia to Paediatric Dental Patients–Current Status and Prospects for the Future.” International Journal of Paediatric Dentistry 12, no. 2 (2002): 80–89.

11.           Prado, Ivana Meyer, Larissa Carcavalli, Lucas Guimarães Abreu, Júnia Maria Serra-Negra, Saul Martins Paiva, and Carolina Castro Martins. “Use of Distraction Techniques for the Management of Anxiety and Fear in Paediatric Dental Practice: A Systematic Review of Randomized Controlled Trials.” International Journal of Paediatric Dentistry 29, no. 5 (2019): 650–68.

12.           Melwani, Anjana M., Ila Srinivasan, Jyothsna V. Setty, Murali Krishna D. R., Sunaina S. Pamnani, and DandamudiLalitya. “A Clinical Comparative Study between Conventional and Camouflaged Syringes to Evaluate Behavior and Anxiety in 6–11-Year-Old Children during Local Anesthesia Administration—a Novel Approach.” Journal of Dental Anesthesia and Pain Medicine 18, no. 1 (February 1, 2018): 35–40.

13.           Khoja, Monika. “Comparative Evaluation of Dental Anxiety and Fear in Children by Using Camouflaged Syringe and Conventional Syringe.” Open Access Journal of Dental Sciences 4, no. 0 (2019).

Vallakatla, Venu, Swathi Vallakatla, Sulagna Dutta, Pallav Sengupta, and Raghavendra Penukonda. “Conventional and Camouflage Syringe during Maxillary Dental Procedures: Relevance to Anxiety and Pain Levels in Children.” Biomedical and Pharmacology Journal 13, no. 1 (March 28, 2020)