Effect of Virtual Reality on Dental Anxiety in Children

NCT05302154 | Completed

• 1 other identifier: 119S618
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Behavior, Child

Keywords

behaviour management techniques; children; distraction; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (3)

• Child's anxiety assessment (objective)

  1 year

• Child's anxiety assessment (subjective)

  1 year

• Child's pain assessment (subjective)

  1 year

Study Arms (3)

Standard treatment group

ACTIVE COMPARATOR

Dental treatment is carried out with tell-show-do technique as a behavioural guidance technique.

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.

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.

Behavioral: Distraction by virtual reality glasses

Interventions

Distraction by dentist BEHAVIORAL

Basic behavior orientation techniques (tell-show-do) is applied by the dentist during the treatment.

Standard treatment group

Distraction by cartoon movie BEHAVIORAL

Children watch cartoons on a screen mounted dental unit during the treatment.

Cartoon movie- passive distraction group

Distraction by virtual reality glasses BEHAVIORAL

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.

VR-active distraction group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Systemically and mentally healthy patients without any previous dental treatment experience,
• Children who required pulpotomy in lower primary molars under local anaesthesia.

You may not qualify if:

• Systemic disease,
• Mental and cognitive disorders, visual and auditory disabilities.

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul Technical University: collaborator

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Elif B Tuna Ince, Prof.

  Department of Pedodontics, Faculty of Dentistry, Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Behavioral: Behavioral guidance Other: Pain assessment Other: Dental anxiety assessment

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 31, 2022
• Study Start: March 11, 2021
• Primary Completion: December 10, 2021
• Study Completion: March 1, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)