Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182462
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-08-17
Brief Title:
Virtual Reality Distraction for Dental Anxiety RCT
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
The Effects of A Virtual Reality Game on Anxiety During Dental Procedures in Children VR-TOOTH A Randomized Controlled Trial Protocol
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments
Main research question Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures
Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play facilitating the dental procedure
The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker alpha-amylase
Main research question Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures
Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play facilitating the dental procedure
The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker alpha-amylase
Detailed Description:
Background
Dental fear and anxiety DFA is a condition that affects approximately 133 to 293 of children and adolescents and is a significant cause of patients avoiding dental care In children DFA is also associated with a lower oral-health-related quality of life Although the etiology of DFA is multifactorial a previous traumatic dental experience is the most predictive factor for DFA The majority of DFA experienced by adults stems from poor dental experiences as children Short term distress during appointments that is not managed properly can accumulate into poor dental experiences and in turn reinforcing DFA into adulthood
Dental patients with special health care needs SHCN are defined as patients requiring additional time and special consideration when receiving treatment due to medical physical cognitive or developmental conditions The population includes children with behaviour eg autism spectrum anxiety ADHD congenital eg trisomy 21 congenital heart disease developmental eg cerebral palsy systemic eg childhood cancer sickle cell disease or cognitive disorders eg intellectual disability Children with SHCN face more barriers to dental care than the overall population Barriers include external factors transportation cost inadequate dental facilities and internal factors fear and poor tolerance Many children with SHCN are cared for by dentists in the community or more often times in hospital dental clinic settings They likewise experience more anxiety than those without a disability which can result in more difficult dental visits or multiple reports of visits
Understanding and assessing DFA in children is important for delivering successful dental care with high satisfaction in this age group Among the vast assessment method options available today self-report assessment parental proxy assessment observation-based assessment and physiological assessment are the four major types of measures for children with SHCN Further salivary alpha-amylase an enzyme correlated to both adrenaline and noradrenaline has also been used as a biomarker for autonomic nervous system activity and stress
Factors in the dental setting that trigger DFA include the loud sounds of dental instruments presence of strangers examining the oral cavity and the fear of pain Of these the anticipation and use of local anesthetic injections are by far the main triggers Although necessary to provide adequate pain control during certain treatments local anesthetic injections are uncomfortable For children the initial injection combined with the feeling of numbness during the procedure is especially distressing Pharmacological agents combined with light to moderate sedation or general anesthesia can also be considered for non-cooperative patients but they are often time consuming and at a higher cost as well as generating health risks Audiovisual distractions such as tabletsTV screens have been used as distraction techniques during dental procedures with overall positive results However there is a lack of interactivity of these techniques and as a result are not enough to distract children from the stressful procedure Further lack of patient cooperation due to DFA often requires dentists treating pediatric populations to end appointments prematurely and sometimes without completion of the planned procedure Treating an anxious and fearful patient can also create an environment of stress for the clinician and associated dental team
Moreover when treating children with SHCN extra time and tools are needed to provide comfortable dental care Depending on the childs diagnosis many have hypersensitivity to external stimuli such as loud noises aversion to specific tastes and difficultly straying from usual daily routines A study by Pagano and colleagues showed that the use of augmented reality was well suited for patients with autism spectrum disorder in preparation for their dental visits Additionally a systematic review by Cunningham and colleagues concluded that virtual reality was a promising tool in dentistry especially with the population of children with autism spectrum disorder or other special needs
Aim of the Study
The aim of the study is to verify the efficacy of a VR immersion game compared to a muted cartoon on a wall-mounted TV to decrease anxiety in pediatric special needs patients undergoing dental procedures The study also aims to gain insight on parent and healthcare providers satisfaction levels on the use of VR during dental appointments
Objectives
The primary research objective is to determine
1 The efficacy of a VR immersion game to decrease dental fear and anxiety in children with special needs requiring dental procedures compared to the standard intervention consisting of watching a cartoon on a muted mounted-TV set
The secondary objectives of this study are as follows
1 To compare parents and healthcare professionals satisfaction levels between the VR distraction group and the standard intervention group
2 To compare physiological parameters pulse oxygen saturation and salivary alpha-amylase between the VR distraction group and the standard intervention group
3 To compare the occurrence of side effects between the VR distraction group and the standard intervention group
4 To compare dental procedure length between the VR distraction group and the standard intervention group
5 To compare the rate of dental procedures completion between the VR distraction group and the standard intervention group
MATERIALS AND METHODS
Design This randomized controlled trial study will follow a parallel design including two groups a control group watching cartoons on a muted mounted wall TV set and an experimental group virtual reality game during the dental procedure
Sample and Setting
This study will include 88 participants including an attrition rate of 10 All participants in this study will be allocated in an equal ratio of 44 per group Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine a pediatric hospital in Montréal Canada This clinic mostly serves patients with special health care needs such as craniofacial abnormalities autism spectrum disorder children battling cancer and others Pediatric patients with SHCN represent around 80 of the total clientele of this clinic while the rest is comprised of otherwise healthy patients with dental traumas and other dental emergencies Participants will be identified by the clinics resident dentist using the scheduling system for upcoming appointments for specific painful dental procedures such as teeth extractions fillings and others The research assistants will proceed to contact the parents or legal guardian in order to provide information on the study and seek parents approval ahead of time An individual independent of the clinical dental will review consent with participants and their parents The information and consent form will be signed by one of the parents on the day of the visit
Randomization and allocation
Randomization will be done through the electronic RedCap system Allocation to either intervention will be randomized by an independent biostatistician from the URCA Applied Clinical Research Unit In order to equalize participants in both arms permuted block randomization with randomly selected block sizes design will be used to randomize participants to their intervention Access to the randomization list will only be granted to the biostatistician and allocation will be concealed using RedCap Research Electronic Data Capture to reduce selection bias
Measure of primary outcome
DFA scores will be evaluated using the Venham Anxiety and Behavioral Scale It is an observation-based assessment by proxy for dental fear and anxiety and are among the most frequent behavior scoring models for DFA It is composed of two scales used to assess the anxiety and uncooperative behavior of children in the dental setting The scale is also found under the name Clinical Anxiety ScaleUncooperative Behaviour Rating Scale CARSBRS or Venham Clinical Cooperation Scale VCCS and Venham Clinical Anxiety Scale VCAS and has been used as anxiety rating scale in other studies that evaluate the efficacy of VR distraction in the management of DFA Both scales consist of a 6-point scale with 6 defined behavioral levels that range from 0 to 5 The highest score defines the highest anxiety level or lack of cooperation A high degree of reliability is seen for both scales even for untrained observers The scale points are measured by proxy and anchored in objective specific and readily observable behaviors The research assistant will evaluate the participants behavior by picking a number from 0 to 5 according to the scale thus for each participant two scores on the levels of anxiety and cooperation for the dental procedure will be obtained at T0 T1 and T2 These scores will also be validated and allocated as a consensus with the attending dentist or dental professional Venham and colleagues pointed out that the scale is reliable and valid and provides interval level measurement It is demonstrated that the scale is proven as a useful instrument for assessing childs responses to dental stress Anxiety score and uncooperative score will both be evaluated at T0 baseline during the procedure at 10 minutes after the beginning of the procedure T1 or at mid-procedure for shorter dental treatments and after the completion of the procedure T2
Virtual reality and Game Specification
Virtual reality VR is defined as an artificial environment which is experienced through sensory stimuli It is a modern tool that can immerse patients in a game or world Commonly used in the medical field to help distract patients during unpleasant procedures such as vaccination and cast removal it has proven to be effective at decreasing anxiety and providing a more positive experience for patients A recent clinical trial by Alshatrat and colleagues concluded that VR is an effective tool in reducing anxiety in young children during dental procedures Moreover a previous study by Ram and colleagues showed that both parent and clinician satisfaction was high using audio-visual glasses as distraction for children during dental treatments However clinical VR research in pediatric dentistry is limited especially with special needs populations VR use in pediatric dentistry offers the potential of an additional non-pharmacologic tool
Developed by Paperplane Therapeutics DREAM DENTAL is tailored for the pediatric population and approved by a team of healthcare professionals in pediatric care The simplified no-success game allows it to be enjoyable no matter the childs video game experience It was designed specifically for this study with the specific horizontal position in mind needed for dental procedures The video game is designed to be supported by the Pico Neo 4 VR headset
The objective of the VR game is to shoot lasers at targets located on the islands such as balloons and trolls It uses a new eye-tracking technology developed within the headset to help direct laser beams without any head movement making it easier for dental procedures where head movement is restricted These features also aim to reduce cybersickness The preliminary version of the VR headset has been tested in clinic on staff - the size and volume of the headset do not hinder delivery of dental care but this will be documented
Dental fear and anxiety DFA is a condition that affects approximately 133 to 293 of children and adolescents and is a significant cause of patients avoiding dental care In children DFA is also associated with a lower oral-health-related quality of life Although the etiology of DFA is multifactorial a previous traumatic dental experience is the most predictive factor for DFA The majority of DFA experienced by adults stems from poor dental experiences as children Short term distress during appointments that is not managed properly can accumulate into poor dental experiences and in turn reinforcing DFA into adulthood
Dental patients with special health care needs SHCN are defined as patients requiring additional time and special consideration when receiving treatment due to medical physical cognitive or developmental conditions The population includes children with behaviour eg autism spectrum anxiety ADHD congenital eg trisomy 21 congenital heart disease developmental eg cerebral palsy systemic eg childhood cancer sickle cell disease or cognitive disorders eg intellectual disability Children with SHCN face more barriers to dental care than the overall population Barriers include external factors transportation cost inadequate dental facilities and internal factors fear and poor tolerance Many children with SHCN are cared for by dentists in the community or more often times in hospital dental clinic settings They likewise experience more anxiety than those without a disability which can result in more difficult dental visits or multiple reports of visits
Understanding and assessing DFA in children is important for delivering successful dental care with high satisfaction in this age group Among the vast assessment method options available today self-report assessment parental proxy assessment observation-based assessment and physiological assessment are the four major types of measures for children with SHCN Further salivary alpha-amylase an enzyme correlated to both adrenaline and noradrenaline has also been used as a biomarker for autonomic nervous system activity and stress
Factors in the dental setting that trigger DFA include the loud sounds of dental instruments presence of strangers examining the oral cavity and the fear of pain Of these the anticipation and use of local anesthetic injections are by far the main triggers Although necessary to provide adequate pain control during certain treatments local anesthetic injections are uncomfortable For children the initial injection combined with the feeling of numbness during the procedure is especially distressing Pharmacological agents combined with light to moderate sedation or general anesthesia can also be considered for non-cooperative patients but they are often time consuming and at a higher cost as well as generating health risks Audiovisual distractions such as tabletsTV screens have been used as distraction techniques during dental procedures with overall positive results However there is a lack of interactivity of these techniques and as a result are not enough to distract children from the stressful procedure Further lack of patient cooperation due to DFA often requires dentists treating pediatric populations to end appointments prematurely and sometimes without completion of the planned procedure Treating an anxious and fearful patient can also create an environment of stress for the clinician and associated dental team
Moreover when treating children with SHCN extra time and tools are needed to provide comfortable dental care Depending on the childs diagnosis many have hypersensitivity to external stimuli such as loud noises aversion to specific tastes and difficultly straying from usual daily routines A study by Pagano and colleagues showed that the use of augmented reality was well suited for patients with autism spectrum disorder in preparation for their dental visits Additionally a systematic review by Cunningham and colleagues concluded that virtual reality was a promising tool in dentistry especially with the population of children with autism spectrum disorder or other special needs
Aim of the Study
The aim of the study is to verify the efficacy of a VR immersion game compared to a muted cartoon on a wall-mounted TV to decrease anxiety in pediatric special needs patients undergoing dental procedures The study also aims to gain insight on parent and healthcare providers satisfaction levels on the use of VR during dental appointments
Objectives
The primary research objective is to determine
1 The efficacy of a VR immersion game to decrease dental fear and anxiety in children with special needs requiring dental procedures compared to the standard intervention consisting of watching a cartoon on a muted mounted-TV set
The secondary objectives of this study are as follows
1 To compare parents and healthcare professionals satisfaction levels between the VR distraction group and the standard intervention group
2 To compare physiological parameters pulse oxygen saturation and salivary alpha-amylase between the VR distraction group and the standard intervention group
3 To compare the occurrence of side effects between the VR distraction group and the standard intervention group
4 To compare dental procedure length between the VR distraction group and the standard intervention group
5 To compare the rate of dental procedures completion between the VR distraction group and the standard intervention group
MATERIALS AND METHODS
Design This randomized controlled trial study will follow a parallel design including two groups a control group watching cartoons on a muted mounted wall TV set and an experimental group virtual reality game during the dental procedure
Sample and Setting
This study will include 88 participants including an attrition rate of 10 All participants in this study will be allocated in an equal ratio of 44 per group Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine a pediatric hospital in Montréal Canada This clinic mostly serves patients with special health care needs such as craniofacial abnormalities autism spectrum disorder children battling cancer and others Pediatric patients with SHCN represent around 80 of the total clientele of this clinic while the rest is comprised of otherwise healthy patients with dental traumas and other dental emergencies Participants will be identified by the clinics resident dentist using the scheduling system for upcoming appointments for specific painful dental procedures such as teeth extractions fillings and others The research assistants will proceed to contact the parents or legal guardian in order to provide information on the study and seek parents approval ahead of time An individual independent of the clinical dental will review consent with participants and their parents The information and consent form will be signed by one of the parents on the day of the visit
Randomization and allocation
Randomization will be done through the electronic RedCap system Allocation to either intervention will be randomized by an independent biostatistician from the URCA Applied Clinical Research Unit In order to equalize participants in both arms permuted block randomization with randomly selected block sizes design will be used to randomize participants to their intervention Access to the randomization list will only be granted to the biostatistician and allocation will be concealed using RedCap Research Electronic Data Capture to reduce selection bias
Measure of primary outcome
DFA scores will be evaluated using the Venham Anxiety and Behavioral Scale It is an observation-based assessment by proxy for dental fear and anxiety and are among the most frequent behavior scoring models for DFA It is composed of two scales used to assess the anxiety and uncooperative behavior of children in the dental setting The scale is also found under the name Clinical Anxiety ScaleUncooperative Behaviour Rating Scale CARSBRS or Venham Clinical Cooperation Scale VCCS and Venham Clinical Anxiety Scale VCAS and has been used as anxiety rating scale in other studies that evaluate the efficacy of VR distraction in the management of DFA Both scales consist of a 6-point scale with 6 defined behavioral levels that range from 0 to 5 The highest score defines the highest anxiety level or lack of cooperation A high degree of reliability is seen for both scales even for untrained observers The scale points are measured by proxy and anchored in objective specific and readily observable behaviors The research assistant will evaluate the participants behavior by picking a number from 0 to 5 according to the scale thus for each participant two scores on the levels of anxiety and cooperation for the dental procedure will be obtained at T0 T1 and T2 These scores will also be validated and allocated as a consensus with the attending dentist or dental professional Venham and colleagues pointed out that the scale is reliable and valid and provides interval level measurement It is demonstrated that the scale is proven as a useful instrument for assessing childs responses to dental stress Anxiety score and uncooperative score will both be evaluated at T0 baseline during the procedure at 10 minutes after the beginning of the procedure T1 or at mid-procedure for shorter dental treatments and after the completion of the procedure T2
Virtual reality and Game Specification
Virtual reality VR is defined as an artificial environment which is experienced through sensory stimuli It is a modern tool that can immerse patients in a game or world Commonly used in the medical field to help distract patients during unpleasant procedures such as vaccination and cast removal it has proven to be effective at decreasing anxiety and providing a more positive experience for patients A recent clinical trial by Alshatrat and colleagues concluded that VR is an effective tool in reducing anxiety in young children during dental procedures Moreover a previous study by Ram and colleagues showed that both parent and clinician satisfaction was high using audio-visual glasses as distraction for children during dental treatments However clinical VR research in pediatric dentistry is limited especially with special needs populations VR use in pediatric dentistry offers the potential of an additional non-pharmacologic tool
Developed by Paperplane Therapeutics DREAM DENTAL is tailored for the pediatric population and approved by a team of healthcare professionals in pediatric care The simplified no-success game allows it to be enjoyable no matter the childs video game experience It was designed specifically for this study with the specific horizontal position in mind needed for dental procedures The video game is designed to be supported by the Pico Neo 4 VR headset
The objective of the VR game is to shoot lasers at targets located on the islands such as balloons and trolls It uses a new eye-tracking technology developed within the headset to help direct laser beams without any head movement making it easier for dental procedures where head movement is restricted These features also aim to reduce cybersickness The preliminary version of the VR headset has been tested in clinic on staff - the size and volume of the headset do not hinder delivery of dental care but this will be documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None