Behavior, ChildNCT05302154
Effect of Virtual Reality on Dental Anxiety in Children
A study testing Distraction by dentist, Distraction by cartoon movie and Distraction by virtual reality glasses in people with Behavior, Child, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to reduce dental anxiety in children by using virtual reality glasses (VRG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child
- What is being tested?
- Distraction by dentist, Distraction by cartoon movie and Distraction by virtual reality glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically and mentally healthy patients without any previous dental treatment experience,
- Children who required pulpotomy in lower primary molars under local anaesthesia.
Who cannot join
- Systemic disease,
- Mental and cognitive disorders, visual and auditory disabilities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Dentistry
Istanbul
About this study
Official title: Virtual Reality as a Distraction Technique in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain and Behaviour
The aim of this study is to reduce dental anxiety in children by using virtual reality glasses (VRG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.
Within the scope of the study, the participants being examined are in a controlled manner from the practice environment. They are attached a VRG and headphones throughout the treatment. With the help of VRG, it is ensured that participants are ready for the treatment. During the treatment, the participant's focus is on various contents in terms of spectacles. Contents include visual (video surveillance) and auditory stimuli (listening to music). They also provide information about treatment to the patient with the help of avatars (characters) and environmental elements that are placed into the VRG application. In addition, dental anxiety is reduced by the fun contents. The goal is to increase the rate of dental treatment success in child patients.
Read more
The effectiveness of virtual reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with VRG. In the course of these experiments, the effects of VRG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of VRG on the level of stress on dental treatment.
Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.
Read the detailed description
The study is being carried out in Istanbul University Department of Pedodontics, period between March 2021 - December 2021 following the ethics committee approval 2018/5. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.
In this randomised parallel clinical study, the sample consisted of 90 children aged between 6-10 years old who applied for routine dental care in paediatric clinic.
Randomization Children are evaluated by the same dentist during the first examination with Frankl Behavior Rating Scale (FBRS) according to their behavioral attitudes and listed by numbers according to the order of application. Participants who do not come to the treatment appointment are recruited again. The volunteers in the top 30 on the list were recruited to Group I (GI), the next 30 volunteers to Group II (GII), and the last group of 30 volunteers to Group III (GIII).
Group I. Dental treatment is carried out using tell-show-do. Group II. Dental treatment is carried out with showing cartoon movie as a passive distraction.
Group III. The active distraction group is treated while wearing the VR headset and interacting with the designed application.
Study Procedure:
The success of the proposed approach is analyzed by the researcher observing the treatment session child's behaviours and physiological data. Pre-operative pulse rate is got from a pulse oximeter to evaluate the child's anxiety objectively. Children's Fear Survey Schedule-Dental Subscale is applied before the beginning of each visit to evaluate the child's subjective anxiety. In addition, FBRS is applied by the dentist. Video recordings are used to measure behavioral responses of the child before the treatment. Facial Image Scale is applied to children before the treatment to measure the pain perception of the children.
During the treatment, pulse rate is got from a pulse oximeter starting from the local anaesthesia application just before, during and after the treatment of local anesthesia.
The details of the treatment to be applied is as follows: Local anaesthesia application, the intraoral procedure with a high-speed rotary instrument, matrix application, restorative treatment (etch/adhesive application/polymerase/composite application with light-curing), finishing.
As soon as the treatment is completed, post-operative pulse rate, Facial Image Scale, Children's Fear Survey Schedule, FBRS are repeated. Moreover at the end of the dental treatment, children are asked whether they are willing to use VR in their next appointment. The answers given to this question are evaluated in 5 stages between "I would never want to" and "I would like it very much". Also dental chair sitting time of the participant during the procedure is recorded in the experimental and control groups.
The anticipated treatment time is determined as 30 minutes. The treatments are planned to be completed in a single session under local anesthesia. Parents are not allowed be with their children during the treatment according to the routine clinical procedure. A fixed camera which is placed in front of the child is used to record the sessions. Facial and body expressions records are evaluated with FBRS.
Basic behavior orientation techniques (tell-show-do, positive encouragement) is applied by the dentist during the treatment of the first group. According to a study in Turkey published in 2019, the most preferred movies were "Super Wings" for boys and "Frozen" for girls. Therefore, these movies are used in group II and group III. VR headset are used during the treatment of the third group. In a vivid dentist room, the explanatory introduction part takes place while the movies are watched in a fairy world or a futuristic world to take the user away from the real world. Specially created animations have enhanced the virtual environment. The application is designed to function in a way not requiring any intervention. From start to the end, the application interacts with the patient using gaze selection and head tracking mechanisms. The avatar characters provide information related to the dental treatment in a joyful manner. Gamification elements such as gaining stars and collecting rewards have been used to keep the patient engaged. Motion blur feature ensures the patient to keep his head still as sudden movements are supposed to be dangerous and undesired by the dentist during the treatment.
- Conditions
- Behavior, Child
- Being tested
- Distraction by dentist, Distraction by cartoon movie, Distraction by virtual reality glasses
- Keywords
- behaviour management techniques, children, distraction, virtual reality
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction by dentistBehavioural
Basic behavior orientation techniques (tell-show-do) is applied by the dentist during the treatment.
Distraction by cartoon movieBehavioural
Children watch cartoons on a screen mounted dental unit during the treatment.
Distraction by virtual reality glassesBehavioural
During the treatment visual and auditory stimuli provide information about treatment to the patient with the help of avatars (characters) and environmental elements placed within the VRG application. In a vivid dentist room, the explanatory introduction part takes place while the movies are watched in a fairy world or a futuristic world to separate the user from the actual location and context. The application was designed to function in such a way as not to require outside intervention. From start to finish, the application interacts with the user through gaze selection and head tracking mechanisms. The avatar characters provide information related to the dental treatment in a joyful manner. Gamification elements such as gaining stars and collecting rewards have been used to keep the patient engaged. Motion blur feature ensures the patient to keep head still as sudden movements are dangerous and undesired by the dentist during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment group | Active comparator | Dental treatment is carried out with tell-show-do technique as a behavioural guidance technique. Receives: Behavioral: Distraction by dentist |
| Cartoon movie- passive distraction group | Experimental | Dental treatment is carried out with showing cartoon movie as a passive distraction during the treatment. Receives: Behavioral: Distraction by cartoon movie |
| VR-active distraction group | Experimental | The active distraction group is treated while wearing the VR headset and interacting with the designed application. Receives: Behavioral: Distraction by virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's behaviour assessment (subjective) Child's pain assessment (subjective)
According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist).
Measured: 1 year
Secondary outcomes (3)
Child's anxiety assessment (objective)
Heart rate is used to determine the anxiety levels of all treated children at certain critical moments of the treatment being. Significant differences in heart rate is compared between groups.
Measured: 1 year
Child's anxiety assessment (subjective)
Children's Fear Survey Schedule-Dental Subscale consists of 15 questions covering different aspects of dental treatment. It was done by asking children to score from 1 (not at all) to 5 (extremely scared) for each question (1 = Not scared at all, 2 = Slightly scared, 3 = A little scared, 4 = Very scared, 5 = Extremely scared). All scores are added together and the total score is obtained between 15 and 75. 15-31 points indicate low level, 32-38 points to moderate, and 39 and above to indicate high level of anxiety. 5 minutes after the end of the dental treatment, children are asked whether they are willing to use VR in their next appointment. The answers given to this question are evaluated in 5 stages between "I would never want to" and "I would like it very much".
Measured: 1 year
Child's pain assessment (subjective)
Facial Image Scale is aimed to measure the pain perception of the child during dental treatment. Subjective responses from children before and after dental treatment is evaluated with five different facial expressions ranging from "very happy" (1) to "very unhappy" (5). With this questionnaire, it is planned to measure the pain perception of the children and make a comparison between the groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Mar 2021
- Primary completion10 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral: Behavioral guidance Other: Pain assessment Other: Dental anxiety assessment
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Technical University
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
- Investigators
- Elif B Tuna Ince, Prof., Study director, Department of Pedodontics, Faculty of Dentistry, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302154
- Sponsor's protocol ID
- 119S618
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Distraction Technique in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain and Behaviour
- ClinicalTrials.gov ID
- NCT05302154
- Acronym / sponsor ID
- 119S618
- Conditions
- Behavior, Child
- Keywords
- behaviour management techniques, children, distraction, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Technical University
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to reduce dental anxiety in children by using virtual reality glasses (VRG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.
Within the scope of the study, the participants being examined are in a controlled manner from the practice environment. They are attached a VRG and headphones throughout the treatment. With the help of VRG, it is ensured that participants are ready for the treatment. During the treatment, the participant's focus is on various contents in terms of spectacles. Contents include visual (video surveillance) and auditory stimuli (listening to music). They also provide information about treatment to the patient with the help of avatars (characters) and environmental elements that are placed into the VRG application. In addition, dental anxiety is reduced by the fun contents. The goal is to increase the rate of dental treatment success in child patients.
The effectiveness of virtual reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with VRG. In the course of these experiments, the effects of VRG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of VRG on the level of stress on dental treatment.
Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.
Detailed description
The study is being carried out in Istanbul University Department of Pedodontics, period between March 2021 - December 2021 following the ethics committee approval 2018/5. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.
In this randomised parallel clinical study, the sample consisted of 90 children aged between 6-10 years old who applied for routine dental care in paediatric clinic.
Randomization Children are evaluated by the same dentist during the first examination with Frankl Behavior Rating Scale (FBRS) according to their behavioral attitudes and listed by numbers according to the order of application. Participants who do not come to the treatment appointment are recruited again. The volunteers in the top 30 on the list were recruited to Group I (GI), the next 30 volunteers to Group II (GII), and the last group of 30 volunteers to Group III (GIII).
Group I. Dental treatment is carried out using tell-show-do. Group II. Dental treatment is carried out with showing cartoon movie as a passive distraction.
Group III. The active distraction group is treated while wearing the VR headset and interacting with the designed application.
Study Procedure:
The success of the proposed approach is analyzed by the researcher observing the treatment session child's behaviours and physiological data. Pre-operative pulse rate is got from a pulse oximeter to evaluate the child's anxiety objectively. Children's Fear Survey Schedule-Dental Subscale is applied before the beginning of each visit to evaluate the child's subjective anxiety. In addition, FBRS is applied by the dentist. Video recordings are used to measure behavioral responses of the child before the treatment. Facial Image Scale is applied to children before the treatment to measure the pain perception of the children.
During the treatment, pulse rate is got from a pulse oximeter starting from the local anaesthesia application just before, during and after the treatment of local anesthesia.
The details of the treatment to be applied is as follows: Local anaesthesia application, the intraoral procedure with a high-speed rotary instrument, matrix application, restorative treatment (etch/adhesive application/polymerase/composite application with light-curing), finishing.
As soon as the treatment is completed, post-operative pulse rate, Facial Image Scale, Children's Fear Survey Schedule, FBRS are repeated. Moreover at the end of the dental treatment, children are asked whether they are willing to use VR in their next appointment. The answers given to this question are evaluated in 5 stages between "I would never want to" and "I would like it very much". Also dental chair sitting time of the participant during the procedure is recorded in the experimental and control groups.
The anticipated treatment time is determined as 30 minutes. The treatments are planned to be completed in a single session under local anesthesia. Parents are not allowed be with their children during the treatment according to the routine clinical procedure. A fixed camera which is placed in front of the child is used to record the sessions. Facial and body expressions records are evaluated with FBRS.
Basic behavior orientation techniques (tell-show-do, positive encouragement) is applied by the dentist during the treatment of the first group. According to a study in Turkey published in 2019, the most preferred movies were "Super Wings" for boys and "Frozen" for girls. Therefore, these movies are used in group II and group III. VR headset are used during the treatment of the third group. In a vivid dentist room, the explanatory introduction part takes place while the movies are watched in a fairy world or a futuristic world to take the user away from the real world. Specially created animations have enhanced the virtual environment. The application is designed to function in a way not requiring any intervention. From start to the end, the application interacts with the patient using gaze selection and head tracking mechanisms. The avatar characters provide information related to the dental treatment in a joyful manner. Gamification elements such as gaining stars and collecting rewards have been used to keep the patient engaged. Motion blur feature ensures the patient to keep his head still as sudden movements are supposed to be dangerous and undesired by the dentist during the treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Behavioral: Behavioral guidance Other: Pain assessment Other: Dental anxiety assessment
| Arm | Type | Receives |
|---|---|---|
| Standard treatment group | Active comparator | Behavioral: Distraction by dentistDental treatment is carried out with tell-show-do technique as a behavioural guidance technique. |
| Cartoon movie- passive distraction group | Experimental | Behavioral: Distraction by cartoon movieDental treatment is carried out with showing cartoon movie as a passive distraction during the treatment. |
| VR-active distraction group | Experimental | Behavioral: Distraction by virtual reality glassesThe active distraction group is treated while wearing the VR headset and interacting with the designed application. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Systemically and mentally healthy patients without any previous dental treatment experience,
- Children who required pulpotomy in lower primary molars under local anaesthesia.
Key exclusion criteria (2 listed)
- Systemic disease,
- Mental and cognitive disorders, visual and auditory disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction by dentistBasic behavior orientation techniques (tell-show-do) is applied by the dentist during the treatment. | Behavioural | Standard treatment group |
| Distraction by cartoon movieChildren watch cartoons on a screen mounted dental unit during the treatment. | Behavioural | Cartoon movie- passive distraction group |
| Distraction by virtual reality glassesDuring the treatment visual and auditory stimuli provide information about treatment to the patient with the help of avatars (characters) and environmental elements placed within the VRG application. In a vivid dentist room, the explanatory introduction part takes place while the movies are watched in a fairy world or a futuristic world to separate the user from the actual location and context. The application was designed to function in such a way as not to require outside intervention. From start to finish, the application interacts with the user through gaze selection and head tracking mechanisms. The avatar characters provide information related to the dental treatment in a joyful manner. Gamification elements such as gaining stars and collecting rewards have been used to keep the patient engaged. Motion blur feature ensures the patient to keep head still as sudden movements are dangerous and undesired by the dentist during the treatment. | Behavioural | VR-active distraction group |
Primary outcome
Child's behaviour assessment (subjective) Child's pain assessment (subjective)
Time frame: 1 year
According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist).
3 secondary outcomes
Child's anxiety assessment (objective)
Time frame: 1 year
Child's anxiety assessment (subjective)
Time frame: 1 year
Child's pain assessment (subjective)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif B Tuna Ince, Prof. study director
Department of Pedodontics, Faculty of Dentistry, Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction by dentist, Distraction by cartoon movie and Distraction by virtual reality glasses in people with Behavior, Child, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's behaviour assessment (subjective) Child's pain assessment (subjective) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.