F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.134041.1 Study Protocol Articles Evaluation and comparison of the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia.

[version 1; peer review: 1 approved with reservations]

 Parakh Himani Conceptualization Data Curation Formal Analysis Investigation Methodology Visualization Writing – Original Draft Preparation https://orcid.org/0000-0003-2942-095X a 1 Thosar Nilima Conceptualization Formal Analysis Funding Acquisition Project Administration Resources Software Supervision Validation Writing – Review & Editing 1 Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Wardha, Maharashtra, 442001, India himaniparakh08@gmail.com

No competing interests were disclosed.

 24 5 2023 2023 12 546 26 4 2023 Copyright: © 2023 Parakh H and Thosar N 2023 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Administration of local anesthesia via injection is the main reason for inducing anxiety in children and if not intervened it aggravates the anxiety in subsequent appointments. There are many approaches, including pharmacological and non-pharmacological methods that can be used to reduce children’s perception of pain and anxiety. A frequently used non-pharmacological behaviour management method to reduce anxiety and procedure pain is distraction. The rationale of distraction is to shift the attention to avert the brain from receiving unwanted stimulus which induce anxiousness. Many approaches including music, television, portable video games, virtual reality (VR) helmet, and virtual reality audio-visual eyewear, have been implemented so far. Kaleidoscope and virtual reality goggles may help as distraction techniques in reducing the levels of anxiety caused during administration of local anesthesia. By the aid of which the operator may be able to make the dental experience child friendly and ultimately provide quality dental care to anxious children. Non pharmacological measures of reducing pain are cost effective and best means that can be used while performing dental procedures. This is a research protocol for a study aimed to evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children.

 Kaleidoscope Virtual Reality Distraction Local anaesthesia Young children The author(s) declared that no grants were involved in supporting this work. Introduction

Anticipation of pain during dental treatment is a frequently reported reason for dental anxiety and fear. Dental anxiety comprises of various physical, mental as well as social components. Anxiety has been defined as a “vague, unpleasant feeling accompanied by a premonition that something undesirable is about to happen”. 1 In the terms of Dental Fear and Anxiety (DFA), Dental anxiety is characterized as significant negative or unpleasant feeling about a dental office and dental procedures; whereas dental phobia is an irrational form of dental anxiety. 2 Dental anxiety is said to be a major contributor to poor oral health. Several studies have shown that the majority of significant triggers come from the sight, sound, and vibratory sensation of dental drills, and sensation of a local anaesthetic injection which is a major cause; subsequently dental fear is associated with past painful experiences and negative staff behaviour. 3 An anxious patient is in a continuous state of restlessness and unease. Children experiencing anxiety during local anesthesia injection gives rise to a significant concern which thus necessitates cognitive - behavioural psychological guidance along with the needed dental treatment. 4 There are many approaches, including pharmacological and non-pharmacological methods that can be used to reduce children’s perception of pain and anxiety. 5 , 6 Amongst which the procedures that focuses on cognitive or behavioural methods include practices such as listening to music, dreaming, hypnosis, use of virtual reality goggles, progressive muscle relaxation, and distraction through various interventional techniques. 7 Attention refers to focusing and processing information from our surroundings. While in anxious state it is important to shift the child’s attention away from the unpleasant stimuli. Distraction works on the principle of diverting the focus and blocking the reception of the unpleasant stimuli that causes anxiety.

Kaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface. Increased blinking of the eyes is directly proportional to task difficulty, which in turn produces stress. In a relaxed situation, such as during kaleidoscope viewing, the number of blinks decreases and thus it controls the general physiological excitation. 8 , 9 Kaleidoscope is being increasingly recognized for its therapeutic and healing value in medical procedures but very few studies on it are available for its use in pediatric dentistry.

Virtual Reality (VR) is a human–computer interface that enables the user to communicate with the computer-generated atmosphere with dynamism. VR actively involves children and is a potent tool in helping children to keep their attention away from frightening and painful procedures. It allows the children to perceive the environment as a safe where they can be free without any risk. 10 , 11

Hence the focus of this study, according to the available literature, is to evaluate and compare effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children.

Protocol

The aim of this study is to evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia .

Objectives are:

To evaluate the effect of kaleidoscope to reduce dental anxiety levels in young children before and after the administration of local anesthesia.

To evaluate the effect of virtual reality goggles to reduce dental anxiety levels in young children before and after the administration of local anesthesia.

To compare effect of kaleidoscope and virtual reality goggles technique to reduce dental anxiety levels in young children before and after the administration of local anesthesia.

This randomized clinical trial will be conducted in an isolated setup over a period of six months. Children from five - eight years old who are healthy, co-operative but anxious and children undergoing dental treatment requiring administration of local anesthesia will be included in the study. Children with known vision problems, psychological abnormalities, children with special health care needs, children suffering from systemic diseases and the parents that are unwilling to participate will be excluded from the study.

Group 1 – Kaleidoscope: The children will be given a kaleidoscope having various changing colours and patterns to watch through just before the starting of the procedure and will be asked to watch through it until the procedure ends.

Group 2 – Virtual reality goggles technique: The children will be asked to wear Virtual Reality goggles and a video to keep the child engaged will be played by clicking on the remote control. VR will be given just before the starting of the procedure and will be asked to watch through it until the procedure ends.

Group 3 – Control group wherein no such distraction technique will be employed.

It is a randomized clinical trial. This is a version 1 of the protocol. Sequence generation by lottery method will be generated. The co-investigator of the department will generate the allocation sequence and will assign participants to interventions. Trial participants, data analysts will be blinded. Data management by double data entry will be done. Personal information about potential and enrolled participants will be collected and maintained in order to protect confidentiality before, during, and after the trial. Comparators Kaleidoscope, Virtual reality goggles technique and conventional behaviour management method will be taken into consideration for comparing as all of them are interventions aiding for reducing the anxiety levels.

The sample size calculation is based on previous research that used a similar study technique and by using the sample size formula for difference between two means, z α + z β 2 δ 1 2 + δ 2 / k 2 ∆ 2 .

A total of 60 children will be included for the study. The participants in each group will be selected by simple random sampling method.

VFAS score using Visual Facial Anxiety Scale is the primary outcomes to be measured. Pulse oximeter to measure physiological signs of oxygen saturation, and pulse rate, respiratory rate are the secondary outcomes to be measured. All the outcomes will be measured before, during and after intervention.

 Data analysis and statistical plan

Analytical tests like Chi square test and student’s t-test will be performed. All the statistical analysis will be performed using SPSS software, version 27.0 p<0.05 will be considered as the level of significance. This randomized clinical trial will be conducted at the Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha. The allocation will be done using lottery method.

 Dissemination

Once completed the study will be published in a PubMed, Scopus indexed journal.

 Discussion

There is a limited literature available regarding the use kaleidoscope as a distraction method for children undergoing dental procedures. Aditya et al. conducted a study to compare various methods of distraction to control anxiety in 60 children between the age group of six - nine years divided into four groups. Group 1 was fidget spinner (FS), Group 2 was kaleidoscope, Group 3 Virtual reality and Group 4 was control group with no distraction. The child’s self-reported anxiety levels using Venham’s picture test (VPT); the pulse oximeter was used to measure physiological signs of oxygen saturation and pulse rate at three intervals i.e. before, during, and after the IANB procedure. The VPT values were lower in the first three groups. Hence it was concluded that Fidget spinner, kaleidoscope, and virtual reality seem to be effective distraction methods and can be recommended as effective approaches to help reduce children’s dental anxiety during IANB procedures. 12 Tailor et al. found out that when Virtual reality (VR) and on-screen audio-visual distraction techniques were used in the age group of 4-8 years the VPT scores were significantly reduced in VR group as compared to On-screen aid group in the first two visits that included procedures of screening, cavity preparation and L.A. administration. 13 The effect of cartoon display and kaleidoscope in children between the ages of 5-12years was assessed and the anxiety levels were scored using Children’s Fear Scale by Molu and Açıkgöz, during echocardiography procedure. A significant difference is evident in anxiety scores before and during between all the intervention groups and it was concluded that use of kaleidoscope is an effective measure in reducing anxiety. 14 Distraction by Kaleidoscope and VR is a promising area for future research in pediatric dentistry because of the rising interest in non-pharmacological methods for behaviour management.

Ethical considerations

Ethical approval for the study was obtained from the Institutional ethics committee of Datta Meghe Institute of Medical Sciences (Deemed to be University) [ref no: DMIMSU (DU)/IEC/2022/756].

The study protocol will be explained to the participating children and their parents.

Further, a written informed consent will be obtained from their parents.

Trial Registration is done under The Clinical Trials Registry - India, the registry number is (CTRI/2023/04/051258- REF/2023/03/065058)

Date of Registration: 03/04/2023

https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=83188&EncHid=56660.93573&modid=1&compid=19

Study status

Yet to be started.

 Data availability

No data is associated with this article.

Reporting guidelines

Zenodo. SPIRIT checklist for “Evaluation and comparison of the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia”. DOI: https://doi.org/10.5281/zenodo.7811753

References Hare J Bruj-Milasan G Newton T : An Overview of Dental anxiety and the non-pharmacological management of dental anxiety. Prim. Dent. J. 2018;7(4):36–39. 10.1177/205016841800700409 Porritt J Buchanan H Hall M : Assessing children’s dental anxiety: a systematic review of current measures. Comm. Dent. Oral Epidemiol. 2013;41(2):130–142. 22970833 10.1111/j.1600-0528.2012.00740.x Oosterink FMD Jongh A de Aartman IHA : What are people afraid of during dental treatment? Anxiety-provoking capacity of 67 stimuli characteristic of the dental setting. Eur. J. Oral Sci. 2008;116:44–51. 10.1111/j.1600-0722.2007.00500.x Armfeild JM Milgrom P : A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011;27:33–39. Carlsson SG Wide Boman U Lundgren J : Dental anxiety – a joint interest for dentists and psychologists. Eur. J. Oral Sci. 2013;121:221–224. 10.1111/eos.12046 Uman LS Birnie KA Noel M : Psychological interventions for needlerelated procedural pain and distress in children and adolescents. Cochrane Database Syst. Rev. 2013;CD005179. 10.1002/14651858.CD005179.pub3 Ozveren H : Non-pharmacological methods at pain management. Hacettepe University Faculty of Health Sciences. Nurs. J. 2011;83e92. Koç Özkan T Polat F : The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels during Venipuncture in Children. J. Perianesth. Nurs. 2020 Apr;35(2):206–211. 10.1016/j.jopan.2019.08.010 Canbulat N Inal S Sönmezer H : Efficacy of distraction methods on procedural pain and anxiety by applying distraction cards and kaleidoscope in children. Asian Nurs. Res (Korean Soc Nurs Sci). 2014 Mar;8(1):23–28. 25030489 10.1016/j.anr.2013.12.001 Carmona Torres JA Cangas Diaz AJ Langer Herrer AI : Applications of 3D Simulation in Mental Health: Utilities and New Developments. Mental Illnesses - Evaluation, Treatments and Implications. 2012. 10.5772/29597 Özalp Gerçeker G Ayar D Özdemir EZ : Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5–12 years old: A randomized controlled study. J. Clin. Nurs. 2019;jocn.1517. Aditya PVA Prasad MG Nagaradhakrishna A : Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial. Heliyon. 2021 Sep 29;7(9):e08092. 34632153 10.1016/j.heliyon.2021.e08092 PMC8488815 Tailor B Bargale S Dave BH : Comparison of Virtual Reality Glasses vs On-screen Distraction Technique in Reduction of Pediatric Dental Anxiety: An in vivo Study. J. South Asian Assoc. Pediatr. Dent. 2021;4(1):22–26. Molu B Açıkgöz A : A randomized controlled study: The effect of preprocedurals ınformative animation watch about echocardiography and ıntraprocedural kaleidoscope watch on anxiety in children. Jpn. J. Nurs. Sci. 2022 Apr;19(2):e12468. 34939313 10.1111/jjns.12468 10.5256/f1000research.147067.r197357 Reviewer response for version 1 Kamatham Rekhalakshmi 1 Referee Vinnakota Dileep Nag 2 Co-referee https://orcid.org/0000-0002-1585-3773 Department of Pediatric and Preventive Dentistry,, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India Department of Prosthodontics, Narayana Dental College, Nellore, Andhra Pradesh, India

Competing interests: No competing interests were disclosed.

 15 9 2023 Copyright: © 2023 Kamatham R and Vinnakota DN 2023 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation approve-with-reservations

It is an interesting protocol. The literature on the comparison of kaleidoscope and virtual reality to reduce dental anxiety in young children is meager. However, there are certain flaws in the methodology:

Authors failed to mention the type of randomized clinical trial and the trial design; whether it is superiority, inferiority or equivalence trial; whether it is parallel or split mouth.

Can elaborate on the inclusion criteria like the procedures that the authors want to consider.

Control group intervention should be modified to usage of basic behavior guidance techniques. We feel it is not proper to mention no such distraction technique. 

Authors can consider other validated outcome measures to assess the anxiety in the children of the considered age group. Please mention whether the visual facial anxiety scale is validated or not. Should clearly mention the primary and secondary outcome measures. 

The sample size determination is not correct. What is the study that the authors have considered for sample size determination?

The authors have wrongly mentioned simple random sampling method. It should not be a sampling method!! Need to modify the randomization, sequence generation methods.

What about blinding? Authors did not mention about blinding aspect.

What is the use of Chi square test? Please describe in detail the application of each test.

Is the study design appropriate for the research question?

Yes

Is the rationale for, and objectives of, the study clearly described?

Yes

Are sufficient details of the methods provided to allow replication by others?

Partly

Are the datasets clearly presented in a useable and accessible format?

Not applicable

Reviewer Expertise:

Pediatric dentistry- Behavioral management; Biostatistics

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above.

Parakh Himani Pedodontics, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Competing interests: NA

 26 12 2023

Thank you for your valuable suggestions.

I have made the corrections in the manuscript regarding the type of randomization, refinement of the inclusion criteria, and outcome measures. Sample size calculation based on key articles is updated.

Information about blinding is available in the protocol section of the manuscript.

To test the null hypothesis, I would like to add that the Chi-square test will be applied as the sample size is more than 30. 

I have uploaded the version 2 with all the modifications as quoted.