Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05663619
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-12-07
Brief Title:
Virtual Reality Distraction and Dental Anxiety Among Anxious Pediatric Patients
Sponsor:
King Abdulaziz University
Organization:
King Abdulaziz University
Study Overview
Official Title:
The Effect of Virtual Reality Distraction on Anxiety Level During Dental Treatment Among Anxious Pediatric Patients A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Objective This study evaluated the effect of Virtual Reality Distraction VRD on dental anxiety among anxious children undergoing prophylactic dental treatment by utilizing both subjective Venham Anxiety and Behavioral Rating Scale VABRS and objective heart rate HR and salivary cortisol level SCL measures Method and Materials This randomized controlled study included 36 6- to 14-year-old healthy and anxious children who needed prophylactic dental treatment and who had a history of previous dental treatment The eligible childrens anxiety level was evaluated using a modified version of Abeer Dental Anxiety Scale-Arabic version M-ACDAS and those who scored at least 14 or more out of 21 were included Participants were randomly distributed to either the VRD or control group In the VRD group participants wore the VRD device during prophylactic dental treatment In the control group subjects received their treatment while watching a video cartoon on a regular screen The participants were videotaped during the treatment and their HR was recorded at four time points Also a sample from each participants saliva was collected twice at the baseline and after the procedure
Detailed Description:
The aim of this study was to evaluate the effect of virtual reality distraction among 6- to 14-year-old anxious children undergoing prophylactic dental treatment by utilizing both subjective Venham Anxiety and Behavioral Rating Scale VABRS and objective heart rate and salivary cortisol level measures
This two-arms parallel randomized controlled study was conducted at the Department of Pediatric Dentistry at King Abdulaziz University Dental Hospital KAUDH between January and May 2022 after obtaining the ethical approval from the Research Ethics Committee of the Faculty of Dentistry 341-11-21 at King Abdulaziz University The study is reported according to the protocol established by the Consolidated Standards of Reporting Trials CONSORT statement 18
The inclusion criteria were 6- to 14-year-old healthy children with a history of previous dental treatment The included subjects also had to have high dental anxiety high score on a modified version of Abeer Children Dental Anxiety Scale M-ACDAS Children with visual or auditory deficits a history of epilepsy andor anxiety disorder and non-Arabic speaking children were excluded
Records of pediatric patients on the dental treatment waiting list were reviewed and potentially eligible children were contacted via the phone The aim of the study was introduced to the parentsguardians and upon agreement to participate an appointment was scheduled
Abeer Children Dental Anxiety Scale ACDAS a cognitive dental anxiety scale is the first Arabic validated cognitive dental anxiety scale developed to measure anxiety in children and adolescents It consists of 19 self-reported questions arranged in a logical order to assess dental anxiety in children 19 In this study the ACDAS was modified M-ACDAS and only seven of the 19 self-reported questions were included to avoid a lengthy questionnaire with the children Figure 1 Each question can be scored 1 2 or 3 by choosing between three faces with different expressions The first face is a smily face and reflects the feeling of being relaxed happy and not scared while the second face represents a neutral feeling and the third face is a sad face and represents anxious and scared feeling The children were asked to circle the face that best represented hisher response to the question Therefore the total values ranged from 7 to 21 The M-ACDAS was used at the beginning of the scheduled appointment in the waiting area to assess the pre-treatment anxiety level of the potentially eligible children Those who scored 14 667 of the maximum score or more were considered anxious and were included in the study Those who scored less than 14 in the M-ACDAS were excluded from the study
An Arabic consent form was obtained from the parentsguardians and a verbal assent was obtained from the child before participation The participants age gender the timing type of treatment provided and behavior during their most recent dental visit were also recorded
A stratified block randomization process was used to randomize the 36 participants into either a VRD or a control group The participants were stratified by gender and then a block size of six was used in each stratum The sequence of assignments in each block was generated using a random number generator To ensure allocation concealment the allocation assignment and sequence were kept with a dental assistant not involved in the study In the VRD group participants wore a VRD device and watched a previously selected favorite cartoon during the prophylactic dental treatment The device was introduced to the participants using the Tell-Show-Do technique at the beginning of the appointment In the control group participants received their treatment while watching a previously selected favorite cartoon on a regular screen For both groups only speakers with no headphones were used
The subjects underwent a dental prophylactic treatment performed by a single trained dental intern using a low-speed handpiece and a rubber cup with prophy paste The dental treatment was conducted in the same order the upper right upper left lower left and lower right quadrants with all the participants The participants were allowed to choose the prophy paste flavor Bubble Gum Cherry Tart Concord grape Mint Parfait Raspberry Jam and Valencia Orange During the treatment the HR was recorded using a pulse oximeter TECNO-GAS pulse oximeter VITAL TEST at four-time points 1 in the waiting area as a baseline 2 in the dental chair before starting the procedure and after the VRD device or the regular screen were turned on 3 during prophylactic dental treatment after prophy of the two quadrants in the upper arch was completed 4 after the procedure was completed and before taking off the VRD device in the VRD group or turning off the regular screen in the control group
During the treatment participants were videotaped using a high-resolution camera Later two trained and calibrated evaluators assessed the participants anxiety using the VABRS independently The scale consists of five defined behavioral categories ranging from zero to five A higher score indicates a greater level of anxiety 20
Two saliva samples were collected from each participant 1 as a baseline in the waiting area 2 after the dental procedure was completed Approximately two mL of saliva was collected using Salivettes and the samples were stored at -20oC until evaluation To minimize the effects of the diurnal cortisol cycle all study procedures and saliva sample collection were performed between 1000 am and 200 pm The cortisol levels were measured using the Cortisol Saliva Enzyme-Linked Immunosorbent Assay ELISA Assay Kit ab 154996- cortisol ELISA kit Abcam UK following the manufacturers instructions
Sample size and statistical analysis A sample size of 18 in each group will have 80 power to detect a difference in means of -15 assuming that the common standard deviation is 15 with a 5 two-sided significance level The Statistical Package for Social Science software for Windows was used for the statistical analysis SPSS Chicago IL USA The participants baseline characteristics were compared using the Mann-Whitney U test chi-square test or Fisher exact test The Mann-Whitney U test was used to compare the three outcomes of the research HR SCL and VABRS between the VRD and control groups The significance threshold was set at 005
This two-arms parallel randomized controlled study was conducted at the Department of Pediatric Dentistry at King Abdulaziz University Dental Hospital KAUDH between January and May 2022 after obtaining the ethical approval from the Research Ethics Committee of the Faculty of Dentistry 341-11-21 at King Abdulaziz University The study is reported according to the protocol established by the Consolidated Standards of Reporting Trials CONSORT statement 18
The inclusion criteria were 6- to 14-year-old healthy children with a history of previous dental treatment The included subjects also had to have high dental anxiety high score on a modified version of Abeer Children Dental Anxiety Scale M-ACDAS Children with visual or auditory deficits a history of epilepsy andor anxiety disorder and non-Arabic speaking children were excluded
Records of pediatric patients on the dental treatment waiting list were reviewed and potentially eligible children were contacted via the phone The aim of the study was introduced to the parentsguardians and upon agreement to participate an appointment was scheduled
Abeer Children Dental Anxiety Scale ACDAS a cognitive dental anxiety scale is the first Arabic validated cognitive dental anxiety scale developed to measure anxiety in children and adolescents It consists of 19 self-reported questions arranged in a logical order to assess dental anxiety in children 19 In this study the ACDAS was modified M-ACDAS and only seven of the 19 self-reported questions were included to avoid a lengthy questionnaire with the children Figure 1 Each question can be scored 1 2 or 3 by choosing between three faces with different expressions The first face is a smily face and reflects the feeling of being relaxed happy and not scared while the second face represents a neutral feeling and the third face is a sad face and represents anxious and scared feeling The children were asked to circle the face that best represented hisher response to the question Therefore the total values ranged from 7 to 21 The M-ACDAS was used at the beginning of the scheduled appointment in the waiting area to assess the pre-treatment anxiety level of the potentially eligible children Those who scored 14 667 of the maximum score or more were considered anxious and were included in the study Those who scored less than 14 in the M-ACDAS were excluded from the study
An Arabic consent form was obtained from the parentsguardians and a verbal assent was obtained from the child before participation The participants age gender the timing type of treatment provided and behavior during their most recent dental visit were also recorded
A stratified block randomization process was used to randomize the 36 participants into either a VRD or a control group The participants were stratified by gender and then a block size of six was used in each stratum The sequence of assignments in each block was generated using a random number generator To ensure allocation concealment the allocation assignment and sequence were kept with a dental assistant not involved in the study In the VRD group participants wore a VRD device and watched a previously selected favorite cartoon during the prophylactic dental treatment The device was introduced to the participants using the Tell-Show-Do technique at the beginning of the appointment In the control group participants received their treatment while watching a previously selected favorite cartoon on a regular screen For both groups only speakers with no headphones were used
The subjects underwent a dental prophylactic treatment performed by a single trained dental intern using a low-speed handpiece and a rubber cup with prophy paste The dental treatment was conducted in the same order the upper right upper left lower left and lower right quadrants with all the participants The participants were allowed to choose the prophy paste flavor Bubble Gum Cherry Tart Concord grape Mint Parfait Raspberry Jam and Valencia Orange During the treatment the HR was recorded using a pulse oximeter TECNO-GAS pulse oximeter VITAL TEST at four-time points 1 in the waiting area as a baseline 2 in the dental chair before starting the procedure and after the VRD device or the regular screen were turned on 3 during prophylactic dental treatment after prophy of the two quadrants in the upper arch was completed 4 after the procedure was completed and before taking off the VRD device in the VRD group or turning off the regular screen in the control group
During the treatment participants were videotaped using a high-resolution camera Later two trained and calibrated evaluators assessed the participants anxiety using the VABRS independently The scale consists of five defined behavioral categories ranging from zero to five A higher score indicates a greater level of anxiety 20
Two saliva samples were collected from each participant 1 as a baseline in the waiting area 2 after the dental procedure was completed Approximately two mL of saliva was collected using Salivettes and the samples were stored at -20oC until evaluation To minimize the effects of the diurnal cortisol cycle all study procedures and saliva sample collection were performed between 1000 am and 200 pm The cortisol levels were measured using the Cortisol Saliva Enzyme-Linked Immunosorbent Assay ELISA Assay Kit ab 154996- cortisol ELISA kit Abcam UK following the manufacturers instructions
Sample size and statistical analysis A sample size of 18 in each group will have 80 power to detect a difference in means of -15 assuming that the common standard deviation is 15 with a 5 two-sided significance level The Statistical Package for Social Science software for Windows was used for the statistical analysis SPSS Chicago IL USA The participants baseline characteristics were compared using the Mann-Whitney U test chi-square test or Fisher exact test The Mann-Whitney U test was used to compare the three outcomes of the research HR SCL and VABRS between the VRD and control groups The significance threshold was set at 005
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