Effectiveness of hypnotic video overlay technique using immersive projection environment in pediatric patients undergoing dental treatment : A Randomized controlled trial

Rationale-

DentalFear and Anxiety is a very common problem in children and adolescents with aprevalence rate of around 12-20 % and thus new strategies to overcome thisshould be encouraged. This Fear and Anxiety related to dental procedures if notresolved properly can have a significant impact on the child’s life whichincludes a lifetime barrier to seek proper oral health care. According to therecent 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 increasinglybeing used in pediatric patients for patients with dental fear and anxiety. Indentistry, video illusions have not been explored extensively for management ofpatient fear and anxiety. In the technologically driven age, an immersivevisual experience for the pediatric patients might be more effective to have abehavior guidance experience and improve the patient’s approach towards gettingthe optimal dental treatment.

 Novelty-

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

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

•       First of its kind Video illusions used incombination with an immersive projection experience for management of dentalanxiety.

 Objectives:

1.    Toprepare the audiovisuals of hypnotic video overlay technique for projection.

2.    Toassess the behaviour of pediatric patients undergoing dental treatment using a hypnoticvideo overlay on a screen.

3.    Toassess the behaviour and vitals of pediatric patients undergoing dentaltreatment using an hypnoticvideo overlay combined with animmersive projection experience.

4.    To assessthe behaviour of pediatric patients undergoing dental treatment usingconventional visual distraction aid using a screen.

5.    Tocompare the behaviour assessment of pediatric patients undergoing dentaltreatment using hypnotic videooverlay,hypnotic video overlay usingan immersive projection experience with the conventional visual distractiontechnique in behavior guidance.

Methods:

Itwill be a single blinded parallel arm randomized controlled study.

1.    After approval from institutional ethics committee illusionvideo will be downloaded

from the internet

2.    According to the inclusion criteria patient selection will bedone and the patient will be asked to sit in the room equipped with immersiveprojection technology.

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

4.   Heart rate and Oxygensaturation with the behaviour assesment scales and skin conductance will berecorded pre operatively, immediately after delivery of local anethesia andpost operatively.

ExpectedOutcome:

Thevideo overlay combined with the immersive ceiling projection will be asuccessful option for pediatric dentists to use as behaviour guidance aid.

Null Hypothesis - Thereis no difference in the effectiveness of the video overlay combined with animmersive projection technology compared to conventional visual distractiontechnique among pediatric patients undergoing dental treatment.

Study Aim and Objectives

Aim- Toevaluate and compare the effectiveness of hypnotic video overlay alone , combined with animmersive projection to conventional visual distraction technique in pediatricpatients undergoing dental treatment.

Objectives-

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

2.   To assess behaviour of pediatric patientsundergoing dental treatment using a hypnotic video overlay combinedwith an immersive projection technology.

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

4.   To compare the effectiveness of the hypnoticvideo overlayalone,combined with immersive projection technology to the conventional visualdistraction aid in behaviour guidance.

**A.**Methodology

I. StudyDesign

It will be a singleblinded parallel arm randomized controlled study.

**II.**Study Area-

The study will beconducted at Department of Pediatric and Preventive Dentistry, Dr D Y PatilDental College and Hospital, Pune.

III. Sample Size

Sample size is calculatedusing 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. Inclusionand Exclusion Criteria-

Inclusion Criteria

Exclusion Criteria

|•        Patients aged from 7-12 years.

•        Patients showcasing behaviour according to the Frankl behaviour rating scale II and III.

•        Patients requiring restorative treatment.

•        Children with special health care needs.

•        Patients with any systemic disorders or psychological conditions.

•        Patients requiring emergency dental treatment

•        Patients that have undergone any previous treatment under local anaesthesia.

•        Patients requiring local anaesthesia for treatment.

**V.**Project Implementation Plan in Detail–

· Afterapproval from the institutional ethics committee, illusion video will be usedthat are available from the internet.

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

·     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 withimmersive projection technology.

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

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

· Heartrate, oxygen saturation, skin conduction and behaviour assessment scales (FacialImage Scale and FLACC scale) will be recorded pre operatively and post operatively.

· Anoperator will be present in the immersive technology room with the child, whilean assessor will evaluate the entire process. Due to the different methods usedin the study, the operator cannot be blinded, but the assessor will be blindedto the trial.

· Results will be noted, and statisticalanalysis will be performed.

VI. Design of Statistical analysis-

Descriptiveand inferential statistics

 VII. Expectedoutcome/ Deliverables aligned with research question

1.    Physiological Indicators- Stabilization or reductionin heart rate and oxygen saturation variations during treatment, indicatingreduced stress levels.

2.    Effectiveness of Immersive Technology- Evidencesupporting the use of immersive ceiling projection technology as a distractiontool to enhance the patient experience during dental procedures.

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

4.    Behaviour assessment will be done meticulouslyusing different scales and values will be assessed at three differentintervals.

**A.**Methodology

I. StudyDesign

It will be a singleblinded parallel arm randomized controlled study.

**II.**Study Area-

The study will beconducted at Department of Pediatric and Preventive Dentistry, Dr D Y PatilDental College and Hospital, Pune.

III. Sample Size

Sample size is calculatedusing 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. Inclusionand Exclusion Criteria-

Inclusion Criteria

Exclusion Criteria

|•        Patients aged from 7-12 years.

•        Patients showcasing behaviour according to the Frankl behaviour rating scale II and III.

•        Patients requiring restorative treatment.

•        Children with special health care needs.

•        Patients with any systemic disorders or psychological conditions.

•        Patients requiring emergency dental treatment

•        Patients that have undergone any previous treatment under local anaesthesia.

•        Patients requiring local anaesthesia for treatment.

**V.**Project Implementation Plan in Detail–

· Afterapproval from the institutional ethics committee, illusion video will be usedthat are available from the internet.

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

·     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 withimmersive projection technology.

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

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

· Heartrate, oxygen saturation, skin conduction and behaviour assessment scales (FacialImage Scale and FLACC scale) will be recorded pre operatively and post operatively.

· Anoperator will be present in the immersive technology room with the child, whilean assessor will evaluate the entire process. Due to the different methods usedin the study, the operator cannot be blinded, but the assessor will be blindedto the trial.

· Results will be noted, and statisticalanalysis will be performed.

VI. Design of Statistical analysis-

Descriptiveand inferential statistics

 VII. Expectedoutcome/ Deliverables aligned with research question

1.    Physiological Indicators- Stabilization or reductionin heart rate and oxygen saturation variations during treatment, indicatingreduced stress levels.

2.    Effectiveness of Immersive Technology- Evidencesupporting the use of immersive ceiling projection technology as a distractiontool to enhance the patient experience during dental procedures.

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

4.    Behaviour assessment will be done meticulouslyusing different scales and values will be assessed at three differentintervals.

**I.**References-

1.     American Academy of Pediatric Dentistry.Behavior guidance for the pediatric dental patient. The Reference Manual ofPediatric 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 DentalAnxiety and Phobia: A Systematic Review and Meta-Analysis. Brain Sci. 2022,12, 521. https://doi.org/10.3390/brainsci12050521

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

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

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

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

7.    RajeswariSR, Chandrasekhar R, Vinay C, et al. Effectiveness of Cognitive Behavioral PlayTherapy and Audiovisual Distraction for Management of Preoperative Anxiety inChildren. Int J Clin Pediatr Dent 2019;12(5):419–422.

8.    DentalAnesthetic 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 oralhealth. International Journal of Recent Trends in Science And Technology. 2016;20:188-190.

10.        Deogade SC, Suresan V. Psychometricassessment of anxiety with the Modified Dental Anxiety scale among centralIndian 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 ofanesthesia during pulp therapy of primary molars in phobic child patients. EurJ Dent 2015;9:470-5.

12. KlingbergG. Dental fear and behavior management problems in children. A study ofmeasurement, prevalence, concomitant factors, and clinical effects. Swed Dent JSuppl. 1995;103:1-78. PMID: 7740439.

**I.**References-

1.     American Academy of Pediatric Dentistry.Behavior guidance for the pediatric dental patient. The Reference Manual ofPediatric 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 DentalAnxiety and Phobia: A Systematic Review and Meta-Analysis. Brain Sci. 2022,12, 521. https://doi.org/10.3390/brainsci12050521

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

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

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

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

7.    RajeswariSR, Chandrasekhar R, Vinay C, et al. Effectiveness of Cognitive Behavioral PlayTherapy and Audiovisual Distraction for Management of Preoperative Anxiety inChildren. Int J Clin Pediatr Dent 2019;12(5):419–422.

8.    DentalAnesthetic 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 oralhealth. International Journal of Recent Trends in Science And Technology. 2016;20:188-190.

10.        Deogade SC, Suresan V. Psychometricassessment of anxiety with the Modified Dental Anxiety scale among centralIndian 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 ofanesthesia during pulp therapy of primary molars in phobic child patients. EurJ Dent 2015;9:470-5.

12. KlingbergG. Dental fear and behavior management problems in children. A study ofmeasurement, prevalence, concomitant factors, and clinical effects. Swed Dent JSuppl. 1995;103:1-78. PMID: 7740439.