Rationale-

Dental Fear and Anxiety is a very common problem in children and adolescents with a prevalence rate of around 12-20 % and thus new strategies to overcome this should be encouraged. This Fear and Anxiety related to dental procedures if not resolved properly can have a significant impact on the child’s life which includes a lifetime barrier to seek proper oral health care. According to the recent guidelines given by the American Association of Pediatric Dentistry (AAPD) in 2020, the best way to practice is by reinforcing a positive attitude, to reduce the dental fear and anxiety by various behavior guidance methods. Medical Hypnotherapy and visual aids for behavior guidance is increasingly being used in pediatric patients for patients with dental fear and anxiety. In dentistry, video illusions have not been explored extensively for management of patient fear and anxiety. In the technologically driven age, an immersive visual experience for the pediatric patients might be more effective to have a behavior guidance experience and improve the patient’s approach towards getting the optimal dental treatment.

Novelty-

•        Illusion exposure has shown reduction in anxiety – Albanese et al, 2020

•        The panoramic view of the illusion video has not been tried in the dental operatory for reducing the dental anxiety.

•        First of its kind Video illusions used in combination with an immersive projection experience for management of dental anxiety.

Objectives:

1.    To prepare the audiovisuals of hypnotic video overlay technique for projection.

2.    To assess the behaviour of pediatric patients undergoing dental treatment using a hypnotic video overlay on a screen.

3.    To assess the behaviour and vitals of pediatric patients undergoing dental treatment using an hypnotic video overlay combined with an immersive projection experience.

4.    To assess the behaviour of pediatric patients undergoing dental treatment using conventional visual distraction aid using a screen.

5.    To compare the behaviour assessment of pediatric patients undergoing dental treatment using hypnotic video overlay, hypnotic video overlay using an immersive projection experience with the conventional visual distraction technique in behavior guidance.

Methods:

It will be a single blinded parallel arm randomized controlled study.

1.    After approval from institutional ethics committee illusion video will be downloaded

from the internet

2.    According to the inclusion criteria patient selection will be done and the patient will be asked to sit in the room equipped with immersive projection technology.

3.    The videos will be then shown to the patients during the entire course of treatment.

4.    Heart rate and Oxygen saturation with the behaviour assesment scales and skin conductance will be recorded pre operatively, immediately after delivery of local anethesia and post operatively.

 Expected Outcome:

The video overlay combined with the immersive ceiling projection will be a successful option for pediatric dentists to use as behaviour guidance aid.

Null Hypothesis - There is no difference in the effectiveness of the video overlay combined with an immersive projection technology compared to conventional visual distraction technique among pediatric patients undergoing dental treatment.

Study Aim and Objectives

Aim- To evaluate and compare the effectiveness of hypnotic video overlay alone , combined with an immersive projection to conventional visual distraction technique in pediatric patients undergoing dental treatment.

Objectives-

1.    To assess behaviour of pediatric patients undergoing dental treatment using hypnotic video overlay.

2.    To assess behaviour of pediatric patients undergoing dental treatment using a hypnotic video overlay combined with an immersive projection technology.

3.    To assess behaviour of pediatric patients undergoing dental treatment using conventional visual distraction technology.

4.    To compare the effectiveness of the hypnotic video overlay alone, combined with immersive projection technology to the conventional visual distraction aid in behaviour guidance.

 A.          Methodology

I.   Study Design

It will be a single blinded parallel arm randomized controlled study.

II.         Study Area-

The study will be conducted at Department of Pediatric and Preventive Dentistry, Dr D Y Patil Dental College and Hospital, Pune.

III.      Sample Size

Sample size is calculated using G power software (V 3.1.9.4) at 5% level of significance and 95% power. The sample size of 60(n = 20) has been confirmed

IV.     Inclusion and Exclusion Criteria-

V.          Project Implementation Plan in Detail –

· After approval from the institutional ethics committee, illusion video will be used that are available from the internet.

· Patient selection will be done according to the inclusion criteria, and the patient will be asked to sit in a room equipped with immersive ceiling projection technology. The patient will be preconditioned to the environment for 10 minutes

·      There will be 3 groups in the study –

o  Group I – behaviour guidance using illusion video shown on a TV screen.

o  Group II- Behaviour guidance using illusion video in combination with immersive projection technology.

o  Group III – Behaviour guidance using conventional visual distraction aid shown on a TV screen.

· The videos will then be shown to the patients throughout the entire course of treatment.

· Heart rate, oxygen saturation, skin conduction and behaviour assessment scales (Facial Image Scale and FLACC scale) will be recorded pre operatively and post operatively.

· An operator will be present in the immersive technology room with the child, while an assessor will evaluate the entire process. Due to the different methods used in the study, the operator cannot be blinded, but the assessor will be blinded to the trial.

· Results will be noted, and statistical analysis will be performed.

VI.      Design of Statistical analysis-

Descriptive and inferential statistics

VII. Expected outcome/ Deliverables aligned with research question

1.    Physiological Indicators- Stabilization or reduction in heart rate and oxygen saturation variations during treatment, indicating reduced stress levels.

2.    Effectiveness of Immersive Technology- Evidence supporting the use of immersive ceiling projection technology as a distraction tool to enhance the patient experience during dental procedures.

3.    Blinded Assessment Validity- Validation of the study design, ensuring unbiased results through a blinded assessor, despite the operator’s involvement in the immersive environment.

4.    Behaviour assessment will be done meticulously using different scales and values will be assessed at three different intervals.

A.          Methodology

I.   Study Design

It will be a single blinded parallel arm randomized controlled study.

II.         Study Area-

The study will be conducted at Department of Pediatric and Preventive Dentistry, Dr D Y Patil Dental College and Hospital, Pune.

III.      Sample Size

Sample size is calculated using G power software (V 3.1.9.4) at 5% level of significance and 95% power. The sample size of 60(n = 20) has been confirmed

IV.     Inclusion and Exclusion Criteria-

V.          Project Implementation Plan in Detail –

· After approval from the institutional ethics committee, illusion video will be used that are available from the internet.

· Patient selection will be done according to the inclusion criteria, and the patient will be asked to sit in a room equipped with immersive ceiling projection technology. The patient will be preconditioned to the environment for 10 minutes

·      There will be 3 groups in the study –

o  Group I – behaviour guidance using illusion video shown on a TV screen.

o  Group II- Behaviour guidance using illusion video in combination with immersive projection technology.

o  Group III – Behaviour guidance using conventional visual distraction aid shown on a TV screen.

· The videos will then be shown to the patients throughout the entire course of treatment.

· Heart rate, oxygen saturation, skin conduction and behaviour assessment scales (Facial Image Scale and FLACC scale) will be recorded pre operatively and post operatively.

· An operator will be present in the immersive technology room with the child, while an assessor will evaluate the entire process. Due to the different methods used in the study, the operator cannot be blinded, but the assessor will be blinded to the trial.

· Results will be noted, and statistical analysis will be performed.

VI.      Design of Statistical analysis-

Descriptive and inferential statistics

VII. Expected outcome/ Deliverables aligned with research question

1.    Physiological Indicators- Stabilization or reduction in heart rate and oxygen saturation variations during treatment, indicating reduced stress levels.

2.    Effectiveness of Immersive Technology- Evidence supporting the use of immersive ceiling projection technology as a distraction tool to enhance the patient experience during dental procedures.

3.    Blinded Assessment Validity- Validation of the study design, ensuring unbiased results through a blinded assessor, despite the operator’s involvement in the immersive environment.

4.    Behaviour assessment will be done meticulously using different scales and values will be assessed at three different intervals.

 I.   References-

1.     American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2022:321-39.

2.    Wolf, T.G.; Schläppi, S.; Benz, C.I.; Campus, G. Efficacy of Hypnosis on Dental Anxiety and Phobia: A Systematic Review and Meta-Analysis. Brain Sci. 2022, 12, 521. https://doi.org/10.3390/ brainsci12050521

3.    Ramírez-Carrasco A, Butrón-Téllez Girón C, Sanchez-Armass O, Pierdant-Pérez M. Effectiveness of Hypnosis in Combination with Conventional Techniques of Behavior Management in Anxiety/Pain Reduction during

4.    Delgado A, Ok SM, Ho D, Lynd T, Cheon K. Evaluation of children’s pain expression and behavior using audio visual distraction. Clin Exp Dent Res. 2021 Oct;7(5):795-802. doi: 10.1002/cre2.407. Epub 2021 Feb 23. PMID: 33622030; PMCID: PMC8543459.

5.    Venkiteswaran A, Tandon S. Role of hypnosis in dental treatment: A narrative review. J Int Soc Prevent Communit Dent 2021;11:115-24.

6.    Tiwari S, Kulkarni P, Agrawal N, et al. Dental Anxiety Scales used in Pediatric Dentistry: A Systematic Review and Meta-analysis. J Contemp Dent Pract 2021;22(11):1338–1345.

7.    Rajeswari SR, Chandrasekhar R, Vinay C, et al. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent 2019;12(5):419–422.

8.    Dental Anesthetic Infiltration. Pain Res Manag. ;2017:1434015. doi: 10.1155/2017/1434015. Epub 2017 Apr 11. PMID: 28490941; PMCID: PMC5405389.

9.    Malik, Mamta & V, Pruthvi & Maurya, Rajkumar & Laller, Sanjeev & Shukla, Chandresh & Saini, Ravinder. Hypnodontics: Role of hypnosis in oral health. International Journal of Recent Trends in Science And Technology. 2016;20:188-190.

10.         Deogade SC, Suresan V. Psychometric assessment of anxiety with the Modified Dental Anxiety scale among central Indian adults seeking oral health care to a dental school. Ind Psychiatry J 2016;25:202-9.

11.         Fakhruddin KS, El Batawi H, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent 2015;9:470-5.

12. Klingberg G. Dental fear and behavior management problems in children. A study of measurement, prevalence, concomitant factors, and clinical effects. Swed Dent J Suppl. 1995;103:1-78. PMID: 7740439.

I.   References-

1.     American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2022:321-39.

2.    Wolf, T.G.; Schläppi, S.; Benz, C.I.; Campus, G. Efficacy of Hypnosis on Dental Anxiety and Phobia: A Systematic Review and Meta-Analysis. Brain Sci. 2022, 12, 521. https://doi.org/10.3390/ brainsci12050521

3.    Ramírez-Carrasco A, Butrón-Téllez Girón C, Sanchez-Armass O, Pierdant-Pérez M. Effectiveness of Hypnosis in Combination with Conventional Techniques of Behavior Management in Anxiety/Pain Reduction during

4.    Delgado A, Ok SM, Ho D, Lynd T, Cheon K. Evaluation of children’s pain expression and behavior using audio visual distraction. Clin Exp Dent Res. 2021 Oct;7(5):795-802. doi: 10.1002/cre2.407. Epub 2021 Feb 23. PMID: 33622030; PMCID: PMC8543459.

5.    Venkiteswaran A, Tandon S. Role of hypnosis in dental treatment: A narrative review. J Int Soc Prevent Communit Dent 2021;11:115-24.

6.    Tiwari S, Kulkarni P, Agrawal N, et al. Dental Anxiety Scales used in Pediatric Dentistry: A Systematic Review and Meta-analysis. J Contemp Dent Pract 2021;22(11):1338–1345.

7.    Rajeswari SR, Chandrasekhar R, Vinay C, et al. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent 2019;12(5):419–422.

8.    Dental Anesthetic Infiltration. Pain Res Manag. ;2017:1434015. doi: 10.1155/2017/1434015. Epub 2017 Apr 11. PMID: 28490941; PMCID: PMC5405389.

9.    Malik, Mamta & V, Pruthvi & Maurya, Rajkumar & Laller, Sanjeev & Shukla, Chandresh & Saini, Ravinder. Hypnodontics: Role of hypnosis in oral health. International Journal of Recent Trends in Science And Technology. 2016;20:188-190.

10.         Deogade SC, Suresan V. Psychometric assessment of anxiety with the Modified Dental Anxiety scale among central Indian adults seeking oral health care to a dental school. Ind Psychiatry J 2016;25:202-9.

11.         Fakhruddin KS, El Batawi H, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent 2015;9:470-5.

12. Klingberg G. Dental fear and behavior management problems in children. A study of measurement, prevalence, concomitant factors, and clinical effects. Swed Dent J Suppl. 1995;103:1-78. PMID: 7740439.