Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05302154 |
| Other study ID # |
119S618 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2021 |
| Est. completion date |
March 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
