Evaluation of dental syringe hiding technique as a distraction method in paediatric dental patients in dental office
- Conditions
- Dental caries, unspecified,
- Registration Number
- CTRI/2023/07/055924
- Lead Sponsor
- Oberoi Ashmeetkaur Sukhbirsingh
- Brief Summary
Dental anxiety in childhood can seriouslyimpact a child’s perception of dentists and greatly diminish the dentalexperience1. A majority of dental procedures in children requireprofound local anesthesia for them to be painless. The irony is that theprocedure of LA administration to make treatments painless, itself isassociated with pain and related anxiety2. Pain and anxiety areoften inter-related. Anxious patients are usually less cooperative andexperience more pain3, thereby affecting the quality of care providedas well as the overall treatment outcome4-6. The very sight ofneedle is what worsens anxiety in children. Also, in India, the parents and thesociety play an active role in inducing anxiety about injections in a child’smind7. It, thus becomes very challenging for a Paediatric Dentist toalleviate this anxiety.
Behaviour management of the child patientforms the cornerstone in paediatric dentistry. Myriad techniques are describedin the literature when it comes to managing the child’s behaviour at the dentaloffice8,9. These include both pharmacological andnon-pharmacological methods. Non-pharmacological methods may include Tell ShowDo, desensitization, modelling, reframing, distraction and hypnosis, whilepharmacological management involves a broad spectrum of agents administered ina variety of ways (e.g., oral, parenteral, and inhalation routes). The childwho requires dental treatment is, frequently, not capable of cooperativebehaviour. The challenge that the clinicians face is to provide an environmentthat allows technically complex dental treatment, starting with the injectionof local anesthetic, to be delivered without inflicting adverse psychologicalor physical harm to the child or others. Administering LA by injection is stillthe most common method used in dentistry. However, there is a constant searchfor ways to avoid the invasive and often painful nature of the injection, andto find a more comfortable and pleasant means of producing local anesthesiabefore dental procedures10.
Dental anxiety caninvolve behavioural, cognitive, emotional, and physiological components, andtheir expression may vary between individuals. Painperception has a large psychological component based on the amount of attentiondirected toward the noxious stimulus modulating the pain. Distractiontechniques are anxiety-reducing strategies that overload the patient’s limitedattention capacity, thus diverting their attention from unpleasant procedures(noxious stimuli). Distraction techniques can be active orpassive. Active techniques involve activities that require the directparticipation of the child, such as the use of toys and games. Passivetechniques rely on the use of music and video and do not require the child todirectly participate.
Distraction seems to be a safe and low-coststrategy that can have a positive impact on young individual’s dental fear andanxiety, thus improving the quality of dental care. Knowledge on theeffectiveness of distraction techniques may be helpful to increase clinician’sconfidence during the management of fearful or anxious children and to assistthe practitioner in the improvement of children’s and adolescent’s behaviourand experience during dental care, creating a more pleasant environment for thepatient, his/her parents and the paediatric dentist11.
Recently, Dental Syringe CamouflageTechnique has gained attention as a Distraction method to reduce needle anxietyin children. There is scarcity of studies conducted to evaluate efficacy ofsuch technique as against the conventional dental syringes. The current studywas planned with this background to answer the research question: “Howeffective shall be camouflaging the dental syringe with a cloth dental syringesleeve in reducing associated needle anxiety in school going children in dentaloffice?â€
***Hypothesis****:* Camouflaged Dental Syringe shall lead to significantreduction of needle related anxiety as compared to use of conventional syringesin school going children during local anesthesia administration.
**AIMAND OBJECTIVES:**
**AIM:**
Tocompare ‘Camouflaged Dental Syringe’ with ‘Conventional Dental Syringe’ for LAadministration in reducing needle associated anxiety in school going childrenin 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 6-9years (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 dentitionperiod) during local anesthesia administration
**Secondary:**
· To compare the effect of Light-coloured with Dark-coloured CamouflagedDental Syringes on child’s Self-reported Dental Anxiety, Self-reported Pain andPhysiological Parameters of Anxiety during the same procedure
**MATERIAL AND METHODS:**
***Study Setting-***
The studywill be conducted in Post-Graduate Clinic, Department of Paediatric andPreventive Dentistry, Faculty of Dental Sciences, King George’s Medical University, Lucknow, Uttar Pradesh
***Study Design:***
Theresearch question will be addressed within a randomized clinical trial studydesign**.**
***Participants:***
Children of any gender inthe age group 6-9 years, visiting Department of Paediatric and PreventiveDentistry, FODS, KGMU, Lucknow, UP; shall be screened for following inclusioncriteria:
***Inclusion criteria:***
Ø Patients requiring dental proceduresindicated for Inferior Alveolar Nerve Block anesthesia (pulp therapies,extractions, or other surgical interventions)
Ø Patients categorized under Frankel’s negativeand positive behaviour categories
Ø No history of previous dental office visits
Ø Patients whose parents give informed consentfor participation
**Exclusion Criteria-**
Ø Children with special health care needs
Ø Children showing positive response to patchtest of Lignocaine
Ø Children whose parents/guardian do not agreefor written informed consent
Pediatricpatients finally fulfilling all inclusion and exclusion criteria shall beenrolled in the study as participants. All participants shall be randomlyassigned to one of the following groups-
**Group I (Control)-** Use of Conventional Dental Syringes for LAadministration
**Group II (Experimental)-** Use of Camouflaged Dental Syringes LAadministration 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 (accordingto study score) among two study groups using the formula
Where *p*1= 0.15 (15%) proportionof no pain in first group
*p*2 =0.543 (54.3%) proportionof no pain in second group
(Ref. Savitha Sathyaprasad, Divyia J., Krishna MoorthyS. H., Rakesh Rajeevan Nair, Shashikala Prabhu.**Camouflage Technique: A NovelBehaviour Management Strategy For Local Anesthesia**)
*e* = *1.75(p*1*-p*2*)*, the attributable risk considered to be clinicallysignificant
Type I error, α=5%
Type II errorβ=10% for setting power of study 90%
The minimum samplesize required **n = 38 each group**
***Randomization******:***
Ablock randomization process shall be followed for allocating participants intocontrol or experimental groups. This involves recruiting participants in shortblocks and ensuring that one-half of the participants within each block are allocatedto “Group I†and the remaining one half to “Group II†within each block toobtain the different combinations. Blocks of ‘Four’ shall be used to allocateto Group I and II respectively. Within Group II, again blocks of ‘four’ will becreated using computer generated sequence to allocate to subgroups.
***Procedure*:**
All participants finally enrolled in thestudy shall be allocated to Control or Experimental groups. The parent/guardianwill be explained about the study in detail in a language well understood bythem and written consent to be taken for the same.
A standard set of instructions shall begiven to all patients prior to LA administration using euphemisms (Annexure1).Patient will not be informed of the actual procedure to be performed post Localanesthesia administration. A baseline data collection will be done before theintervention.
The intervention willbe carried out by a single investigator to avoid procedural and examiner bias.The outcomes shall be measured by different observers. The order ofinstructions shall be kept identical for all the groups. Use of a topicalanesthetic gel will be common for all the groups. A video of each patientduring local anesthesia administration will be recorded to note the facialexpressions 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 byasking the patient to choose the most-apt picture in the report card.**
Change in anxiety scoresusing Venham Picture Test both pre and post LA administration
- Painperception: Wong-Baker FACES Pain Rating Scale post LA administration
*Objectivemeasures**:* These shall be recorded by an observer otherthan the one performing the LA administration.
- Change inOxygen saturation (SpO2) post-intervention
- Change inHeart rate post-intervention
- Change inBlood pressure post-intervention
**Secondary:**
All Subjective and Objective measures shallbe observed and compared within subgroups of Experimental group usingCamouflaged Dental Syringes.
**DATA COLLECTION:**
**Data for followingvariables shall be collected as defined in Outcomes as inter and intra groupcomparison**
- Change in anxiety scores
- Wong-Baker FACES Pain Rating scores
- Change inOxygen saturation (SpO2) post-intervention
- Change inHeart rate post-intervention
- Change inBlood pressure post-intervention
**DATA ANALYSIS:**
Data will be analyzed and expressed in mean (SD) orproportion/percentage or Median values depending on type of data.
- Change in anxiety scores: Shall elicit ‘ordinal’/‘discrete’ data
- Wong-Baker FACES Pain Rating scores: Shallelicit ‘ordinal’/ ‘discrete’ data
- Change inOxygen saturation (SpO2) post-intervention: shall elicit ‘continuous’ data
- Change inHeart rate post-intervention: shall elicit ‘continuous’ data
- Change inBlood pressure post-intervention: shall elicit ‘continuous’ data
The observations between the groups shall be compared with Mann WhitneyTest for all discrete/ordinal data. Wilkoxan sign rank test shall be used tocompare observations pre and post intervention for all discrete/ordinal dataobservations. Observations of continuous variables shall also be compared withsimilar non parametric tests since sample is not being retrieved from aGaussian population. p-value < 0.05 will betaken as the significance level.
**REVIEW OF LITERATURE:**
**Anjana M Melwani *et al.***12 comparedthe efficacy of a camouflaged syringe and conventional syringe on behaviour andanxiety in 6-11 year old children during local anesthesia administration. Theyconcluded that camouflaged syringes for anesthesia are effective in improvingbehaviour of children and decreasing their anxiety.
**Savitha Sathyaprasad *et al.***7 used amodified syringe pattern camouflaged with the child’s favourite cartooncharacter and found better management of children when such a method wasapplied as made evident by their improved Frankel behaviour score.
**Monika K. *et al.***13 comparedcamouflaged and conventional syringes in eliminating dental anxiety and fear inchildren. They found that fear and anxiety was significantly reduced whencamouflaged syringes are used.
**Venu Vallakatla *et al.***14 comparedthe effects of conventional and camouflaged syringe in reducing anxiety andpain levels during maxillary dental procedures in paediatric patients. Theyconcluded that the use of camouflaged syringe was associated with improvedoutcomes related to dental fear and anxiety in children.
**References:**
1. Majstorovic, M., D. E. Morse, D. Do, L. lLim, N. G. Herman, and A. M. Moursi. “Indicators of Dental Anxiety in ChildrenJust Prior to Treatment.†*The Journal of Clinical Pediatric Dentistry*39, no. 1 (2014): 12–17.
2. Davis, M. J., and L. D. Vogel. “Local AnestheticSafety 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 ItsAssociation with Pain and Other Variables among Adult Patients withIrreversible Pulpitis.†*BMC Oral Health* 18, no. 1 (2018): 1–6.
4. Al-Khalifa, Khalifa S. “Prevalence of DentalAnxiety in Two Major Cities in the Kingdom of Saudi Arabia.†*Saudi Journalof 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 Changesduring Surgical Removal of Lower Third Molar under Local Anesthesia.†*Annalsof 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 LocalAnesthesia,†2020.
8. Curtis, Sarah, Aireen Wingert, and Samina Ali. “TheCochrane Library and Procedural Pain in Children: An Overview of Reviews.†*Evidence-BasedChild 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 DiasTorriani. “Nonpharmacologic Intervention on the Prevention of Pain and Anxietyduring Pediatric Dental Care: A Systematic Review.†*Academic Pediatrics*17, no. 2 (2017): 110–19.
10. Ram, D., and B. Peretz. “Administering LocalAnaesthesia to Paediatric Dental Patients–Current Status and Prospects for theFuture.†*International Journal of Paediatric Dentistry* 12, no. 2 (2002):80–89.
11. Prado, Ivana Meyer, Larissa Carcavalli, LucasGuimarães Abreu, Júnia Maria Serra-Negra, Saul Martins Paiva, and CarolinaCastro Martins. “Use of Distraction Techniques for the Management of Anxietyand Fear in Paediatric Dental Practice: A Systematic Review of RandomizedControlled 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, andDandamudiLalitya. “A Clinical Comparative Study between Conventional andCamouflaged Syringes to Evaluate Behavior and Anxiety in 6–11-Year-Old Childrenduring Local Anesthesia Administration—a Novel Approach.†*Journal of DentalAnesthesia and Pain Medicine* 18, no. 1 (February 1, 2018): 35–40.
13. Khoja, Monika. “Comparative Evaluation ofDental Anxiety and Fear in Children by Using Camouflaged Syringe andConventional Syringe.†*Open Access Journal of Dental Sciences* 4, no. 0(2019).
Vallakatla,Venu, Swathi Vallakatla, Sulagna Dutta, Pallav Sengupta, and RaghavendraPenukonda. “Conventional and Camouflage Syringe during Maxillary DentalProcedures: Relevance to Anxiety and Pain Levels in Children.†*Biomedicaland Pharmacology Journal* 13, no. 1 (March 28, 2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 76
Patients requiring dental procedures indicated for Inferior Alveolar Nerve Block anesthesia (pulp therapies, extractions, or other surgical interventions) Patients categorized under Frankel’s negative and positive behaviour categories No history of previous dental office visits Patients whose parents give informed consent for participation.
Children with special health care needs Children showing positive response to patch test of Lignocaine Children whose parents/guardian do not agree for written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective measures These shall be recorded by asking the patient to choose the most apt picture in the report card. Immediate post intervention Change in anxiety scores using Venham Picture Test both pre & post LA administration Immediate post intervention Pain perception Wong-Baker FACES Pain Rating Scale post LA administration Immediate post intervention Objective measures These shall be recorded by an observer other than the one performing the LA administration. Immediate post intervention Change in Oxygen saturation (SpO2) post intervention Immediate post intervention Change in Heart rate post intervention Immediate post intervention Change in Blood pressure post intervention Immediate post intervention
- Secondary Outcome Measures
Name Time Method All subjective as well as objective measures shall be observed as well as compared within subgroups of experimental group using camouflaged dental syringes Immediate post intervention
Trial Locations
- Locations (1)
Faculty of Dental Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Faculty of Dental Sciences🇮🇳Lucknow, UTTAR PRADESH, IndiaOberoi Ashmeetkaur SukhbirsinghPrincipal investigator7498063407ashmeetkauroberoi283@gmail.com