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RECRUITING
NCT07848542
NA

Multisensory Approaches for Managing Pediatric Dental Anxiety

Sponsor: Bezmialem Vakif University

View on ClinicalTrials.gov

Summary

The purpose of this prospective, randomized, single-blind clinical study is to evaluate and compare the effectiveness of distraction using virtual reality (VR) glasses and deep-pressure stimulation using weighted blankets on dental anxiety, cooperation, and pain perception in school-aged children. The study focuses on children aged 5-9 years with high dental anxiety (CFSS-DS score ≥39) who require dental procedures involving local anesthesia, such as Class II restorations, pulpotomy, or extractions. Participants will be randomly assigned to four groups: a control group receiving standard behavior guidance, a VR group, a weighted blanket group, and a combined group using both VR and weighted blankets. The study aims to determine the effects of these non-pharmacological, non-invasive, sensory-based interventions on children's clinical experience and physiological parameters.

Official title: Evaluation of the Effects of Virtual Reality and Weighted Blanket Use on Dental Anxiety Among School-Aged Children With High Dental Anxiety

Key Details

Gender

All

Age Range

5 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08-19

Completion Date

2027-04

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

OTHER

Basic Behavior Guidance

Traditional non-pharmacological behavior management techniques, including the "Tell-Show-Do" method, positive reinforcement, and distraction through verbal communication, will be used as a standard protocol.

OTHER

Deep Pressure Stimulation

A 3 kg weighted blanket will be placed over the participant's body during the dental treatment. This intervention aims to provide deep pressure stimulation to promote relaxation and decrease behavioral stress responses.

DEVICE

Virtual Reality Distraction

The participant will wear a Virtual Reality headset during the dental procedure. Audio-visual content specifically selected for pediatric distraction will be played to divert the child's attention away from dental stimuli and reduce anxiety.

Locations (1)

Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, Fatih, Turkey (Türkiye)