RECRUITING Not applicable ClinicalTrials.gov

Multisensory Approaches for Managing Pediatric Dental Anxiety

Sponsor: Bezmialem Vakif University • ClinicalTrials.gov ID: NCT07848542

Registry updated: 2026-09-30

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Basic Behavior Guidance (Other)
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.
Deep Pressure Stimulation (Other)
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.
Virtual Reality Distraction (Device)
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.

Eligibility criteria

Inclusion Criteria: * Children aged between 5 and 9 years. * Children with a total score of 39 or higher on the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). * Requirement for dental treatment necessitating local anesthesia, such as Class II restorations, pulpotomy, pulpectomy, or extractions. * Systemically healthy children classified as ASA I or ASA II. * Voluntary participation of both the child and the parent, with written informed consent obtained from the parent. * Body weight between 15 and 30 kg, ensuring that the 3-kg weighted blanket corresponds to 10-20% of the child's body weight. Exclusion Criteria: * Children with a CFSS-DS score of 38 or lower. * Presence of intellectual or developmental disabilities. * Presence of visual or hearing impairments. * Presence of neurodevelopmental or neurological disorders, such as epilepsy. * Acute or chronic respiratory diseases. * Neuromuscular or orthopedic conditions that may pose a risk during the use of the weighted blanket. * History of dizziness, nausea, or vertigo associated with virtual reality use. * Refusal of the specific interventions, namely VR glasses or the weighted blanket, by the child or the parent.

Conditions

Pediatric Dental Anxiety Dental Anxiety

Locations

Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry — Istanbul, Fatih, Turkey (Türkiye)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment