Multisensory Approaches for Managing Pediatric Dental Anxiety

September 23, 2026 updated by: Mustafa Sarp Kaya, Bezmialem Vakif University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
Time Frame: During the dental examination session, before dental treatment.

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
Time Frame: Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.

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
Time Frame: Immediately before dental treatment ande immediately after dental treatment.

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
Time Frame: Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.

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
Time Frame: Immediately before and immediately after local anesthetic injection.

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
Time Frame: Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.

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)
Time Frame: Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa Sarp Kaya, Associate Professor, Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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