Pediatric Dental AnxietyNCT07848542
Multisensory Approaches for Managing Pediatric Dental Anxiety
A study testing Basic Behavior Guidance, Deep Pressure Stimulation and Virtual Reality Distraction in people with Pediatric Dental Anxiety and Dental Anxiety, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dental Anxiety, Dental Anxiety
- What is being tested?
- Basic Behavior Guidance, Deep Pressure Stimulation and Virtual Reality Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Dental Anxiety, Dental Anxiety
- Being tested
- Basic Behavior Guidance, Deep Pressure Stimulation, Virtual Reality Distraction
- Keywords
- virtual reality, weighted blanket, deep pressure stimulation, distraction techniques, behavior guidance, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Behavior GuidanceOther
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 StimulationOther
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 DistractionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Basic Behavior Guidance |
| Virtual Reality Group | Experimental | 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. Receives: Device: Virtual Reality Distraction |
| Weighted Blanket Group | Experimental | 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. Receives: Other: Deep Pressure Stimulation |
| Combined Intervention Group | Experimental | 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. Receives: Other: Deep Pressure Stimulation; Device: Virtual Reality Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately before and immediately after local anesthetic injection.
Heart Rate
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.
Measured: 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 (%).
Measured: Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start19 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "A four-arm, prospective, randomized, single-blind clinical trial."
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Sarp Kaya, Bezmialem Vakif University
- Investigators
- Mustafa Sarp Kaya, Associate Professor, Principal investigator, Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848542
- Sponsor's protocol ID
- 2026/915
- Status last verified
- Sep 2026
- First submitted
- 23 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Virtual Reality and Weighted Blanket Use on Dental Anxiety Among School-Aged Children With High Dental Anxiety
- ClinicalTrials.gov ID
- NCT07848542
- Acronym / sponsor ID
- 2026/915
- Conditions
- Pediatric Dental Anxiety, Dental Anxiety
- Keywords
- virtual reality, weighted blanket, deep pressure stimulation, distraction techniques, behavior guidance, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- "A four-arm, prospective, randomized, single-blind clinical trial."
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Basic Behavior GuidanceParticipants 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. |
| Virtual Reality Group | Experimental | Device: Virtual Reality DistractionParticipants 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. |
| Weighted Blanket Group | Experimental | Other: Deep Pressure StimulationParticipants 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. |
| Combined Intervention Group | Experimental | Other: Deep Pressure Stimulation, Device: Virtual Reality DistractionParticipants 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. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Behavior GuidanceTraditional 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 | Control Group |
| Deep Pressure StimulationA 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. | Other | Combined Intervention Group, Weighted Blanket Group |
| Virtual Reality DistractionThe 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. | Device | Combined Intervention Group, Virtual Reality Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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 (%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mustafa Sarp Kaya, Associate Professor principal investigator
Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Behavior Guidance, Deep Pressure Stimulation and Virtual Reality Distraction in people with Pediatric Dental Anxiety and Dental Anxiety, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Evirken, DDS (+90 543 927 76 86, ayse.evirken@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score (time frame: During the dental examination session, before dental treatment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.