Multisensory Approaches for Managing Pediatric Dental Anxiety

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety; Pediatric Dental Anxiety
• Intervention / Treatment: Other: Basic Behavior Guidance; Device: Virtual Reality Distraction; Other: Deep Pressure Stimulation

Detailed Description

This clinical trial is designed as a four-arm, randomized controlled study to compare sensory-based behavior guidance techniques in pediatric dentistry.

Study Arms:

Group 1 (Control): Treatment with basic behavior guidance techniques.

Group 2 (VR): Treatment using virtual reality (VR) glasses as a distraction tool.

Group 3 (WB): Treatment using a 3-kg weighted blanket for deep-pressure stimulation.

Group 4 (Combined): Simultaneous use of VR glasses and a weighted blanket.

Methodology:

Children aged 5-9 years who meet the inclusion criteria will be evaluated at multiple time points: pre-treatment, during local anesthesia, and post-treatment.

Outcome Measures:

Dental Anxiety: Assessed using the Facial Image Scale (FIS) and the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).

Cooperation: Evaluated using the Frankl Behavior Rating Scale and the FLACC (Face, Legs, Activity, Cry, Consolability) scale.

Pain Perception: Measured using the Wong-Baker FACES Pain Rating Scale.

Physiological Parameters: Heart rate and oxygen saturation will be monitored throughout the procedure.

Acceptability: Subjective feedback from children and parents will be collected via post-treatment surveys to assess the feasibility of and satisfaction with the interventions.

Inclusion is restricted to systemically healthy children (ASA I-II) whose body weight (15-30 kg) is compatible with the 3-kg weighted blanket to ensure safety and appropriate therapeutic pressure.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Evirken, DDS; Phone Number: +90 543 927 76 86; Email: ayse.evirken@bezmialem.edu.tr
• Study Contact Backup: Name: Mustafa Sarp Kaya, Associate Professor; Phone Number: +90 532 230 68 01; Email: mskaya@bezmialem.edu.tr

Study Locations

• Turkey (Türkiye)
  • Fatih
    • Istanbul, Fatih, Turkey (Türkiye), 34093
      • Recruiting
      • Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in this group will receive dental treatment using only basic behavior guidance techniques, such as tell-show-do and positive reinforcement, without any additional sensory 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.
Experimental: Virtual Reality Group; Participants will wear virtual reality (VR) glasses during the dental procedure. The VR system will be used as a visual and auditory distraction tool to reduce dental anxiety and pain perception.	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.
Experimental: Weighted Blanket Group; Participants will be covered with a 3-kg weighted blanket during the dental procedure to provide deep-pressure stimulation. This non-pharmacological intervention aims to promote relaxation and reduce physiological stress responses.	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.
Experimental: Combined Intervention Group; Participants in this group will receive a combination of the two interventions during the entire dental procedure: virtual reality (VR) glasses for distraction and a weighted blanket for deep-pressure stimulation.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score	Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The total score ranges from 15 to 75, with higher scores indicating greater dental fear and anxiety.	During the dental examination session, before dental treatment.
Facial Image Scale (FIS) Score	Dental anxiety will be assessed using the Facial Image Scale (FIS), a 5-point facial image scale ranging from 1 to 5, with higher scores indicating greater dental anxiety. FIS scores will be recorded at three time points: immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.	Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
Frankl Behavior Rating Scale Score	Child behavior and cooperation during dental treatment will be assessed using the Frankl Behavior Rating Scale, which categorizes behavior into four levels ranging from definitely negative to definitely positive.	Immediately before dental treatment ande immediately after dental treatment.
FLACC Behavioral Pain Assessment Score	Pain-related behavioral responses will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral response. Assessment will be performed by an independent evaluator blinded to group allocation using standardized video recordings.	Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
Wong-Baker FACES Pain Rating Scale Score	Self-reported pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.	Immediately before and immediately after local anesthetic injection.
Heart Rate	Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.	Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
Peripheral Oxygen Saturation (SpO₂)	Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as percentage (%).	Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Mustafa Sarp Kaya, Associate Professor, Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: September 23, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 23, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: virtual reality; weighted blanket; deep pressure stimulation; pediatric dentistry; distraction techniques; behavior guidance
• Other Study ID Numbers: 2026/915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical committee approval and local data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No