Effect of Augmented Reality on Dental Anxiety and Pain Perception in Children

NCT06530654 | Completed

• 1 other identifier: 123S793
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to reduce dental anxiety in children by using augmented reality (AG) 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. The effectiveness of augmented 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 AG. In the course of these experiments, the effects of AG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of AG 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

Anxiety; Pain

Keywords

Pain Management; Anxiety; Child; Application Software Development; Augmented Reality; Human Computer Interaction

Outcome Measures

Primary Outcomes (1)

• Child's anxiety assessment (objective)

  In order to determine the stress levels of the children included in the study, cortisol, α-Amylase and CHGA levels in saliva will be measured

  1 year

Secondary Outcomes (4)

• Child's anxiety assessment (objective)

  1 year

• Child's anxiety assessment (subjective)

  1 year

• Child's pain assessment (subjective)

  1 year

• Child's behaviour assessment (subjective) Child's pain assessment (subjective)

  1 year

Study Arms (3)

Standard treatment group

ACTIVE COMPARATOR

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

Behavioral: Distraction by dentist

Cartoon movie- passive distraction group

EXPERIMENTAL

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

Behavioral: Distraction by cartoon movie

AG-active distraction group

EXPERIMENTAL

A tablet will be used for AG notation. How to use AG will be shown to the pediatric patient just before the treatment. Since it is aimed to keep the verbal communication of the dentist with the child at the lowest level, a similar "tell-show-do" technique used in the control group will be digitally simulated on the AG. The instruments that the dentist will use during the procedure will be promoted on AG using animated content.

Behavioral: AG-active distraction group

Interventions

Distraction by dentist BEHAVIORAL

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

Standard treatment group

Distraction by cartoon movie BEHAVIORAL

Dental treatment is carried out with showing cartoon movie as a passive distraction during the treatment.

Cartoon movie- passive distraction group

AG-active distraction group BEHAVIORAL

The active distraction group is treated and interacting with the designed application

AG-active distraction group

Eligibility Criteria

• Age: 6 Years - 8 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, Department of Pedodontics

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Elif Tuna Ince, Prof.Dr.

  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

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: July 1, 2024
• Primary Completion: June 2, 2025
• Study Completion: July 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)