Dental Anxiety in ChildrenVR-PEDNCT07693764
Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction
A study testing Virtual reality headset, Audio-visual distraction with 2D cartoons and Tell-show-do with verbal distraction in people with Dental Anxiety in Children and Pain Perception, run by Sultan Qaboos University at 2 sites in Oman.
Trial summary
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Anxiety in Children, Pain Perception
- What is being tested?
- Virtual reality headset, Audio-visual distraction with 2D cartoons and Tell-show-do with verbal distraction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesOman
- Study dates
- 1 Sep 2026to 1 Oct 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 10 years
- Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
- Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
- Children with NO previous exposure to invasive dental procedure
- No prior experience using VR glasses
- Requiring extraction of mandibular deciduous molar under local anesthesia
Who cannot join
- ASA 3 and above
- Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
- Special needs ( intellectual and developmental)
- Children on psychotropic medication
- Children wearing glasses
- Presence of intra-oral swelling
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd) contact
Oman2 sites
Sultan Qaboos University Hospital - Dental & Maxillofacial Department
Muscat
Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd), +96895692669, Azzak@squ.edu.om
Mohammed AlAzki, DSA, +968-97674606, m.alazki@squ.edu.om
The Medical City of Military and Security Service (Dental Center-AlKhoudh )
Muscat
Dr.Khalifa AlAzri, DclinDent (Ed), MPaeds (RCSEd), +968-98199877, Khalifaazri_omsb@outlook.com
Majid AlFori, DSA, 00968-99668984, Superhero-9w8@gmail.com
About this study
Official title: "Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:
Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?
Read more
Does virtual reality distraction reduce pain perception during dental extraction?
Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.
Participants will:
Wear VR glasses to watch immersive 3D cartoons, or
Watch 2D cartoons with headset, or
Receive the conventional tell-show-do technique with verbal distraction.
Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
- Conditions
- Dental Anxiety in Children, Pain Perception
- Being tested
- Virtual reality headset, Audio-visual distraction with 2D cartoons, Tell-show-do with verbal distraction
- Keywords
- pediatric dentistry, dental anxiety, tooth extraction, virtual reality, VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.
Audio-visual distraction with 2D cartoonsBehavioural
Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.
Tell-show-do with verbal distractionBehavioural
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Virtual Reality Distraction | Experimental | Children wear VR glasses to watch immersive 3D cartoons during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters Receives: Device: Virtual reality headset |
| Arm 2: Audio-Visual Distraction | Active comparator | Children watch 2D cartoons with headset during dental extraction. Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group. Receives: Behavioral: Audio-visual distraction with 2D cartoons |
| Arm 3: Conventional Tell-Show-Do | Active comparator | Children receive the standard tell-show-do technique with verbal distraction during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters. Receives: Behavioral: Tell-show-do with verbal distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Dental Anxiety (Self-Report)
Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.
Measured: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
Child Dental Anxiety (Observation-based Assessment)
Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).
Measured: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
3a: Physiological Monitoring - Pulse Rate
Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age:
Preschool children (3-5 years): ~80-120 bpm
School-aged children (6-12 years): ~70-118 bpm
Adolescents (13-18 years): ~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).
Measured: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
3b: Physiological Monitoring - Oxygen Saturation (SpO₂)
Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).
Measured: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Secondary outcomes (2)
Pain Perception (Self-Report)
Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version). This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome)
Measured: at the end of the procedure
Child Behavior (Observation)
Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:
- (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism.
- (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced.
- (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation.
- (Definitely Positive): Good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation.
The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome).
Measured: Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- 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
- This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd), Study director, Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd), Study director, Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security ServicesDr. Zamzam Ali Alqulhati, BDS, MFD(RCSI), Principal investigator, Oman Medical Specialty Boaered
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693764
- Sponsor's protocol ID
- PED-VR-2026-A
- Other IDs
- OMSBoard-2026
- Acronym
- VR-PED
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations in pediatric populations, privacy concerns, and institutional policy. Only aggregated results will be published in peer-reviewed journals and presented at scientific meetings.
Publications
Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7.
PubMed 38087294Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.
PubMed 39465519Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019.
PubMed 34300185
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07693764
- Acronym / sponsor ID
- VR-PED / PED-VR-2026-A
- Conditions
- Dental Anxiety in Children, Pain Perception
- Keywords
- pediatric dentistry, dental anxiety, tooth extraction, virtual reality, VR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Jul 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 goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:
Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?
Does virtual reality distraction reduce pain perception during dental extraction?
Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.
Participants will:
Wear VR glasses to watch immersive 3D cartoons, or
Watch 2D cartoons with headset, or
Receive the conventional tell-show-do technique with verbal distraction.
Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Virtual Reality Distraction | Experimental | Device: Virtual reality headsetChildren wear VR glasses to watch immersive 3D cartoons during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters |
| Arm 2: Audio-Visual Distraction | Active comparator | Behavioral: Audio-visual distraction with 2D cartoonsChildren watch 2D cartoons with headset during dental extraction. Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group. |
| Arm 3: Conventional Tell-Show-Do | Active comparator | Behavioral: Tell-show-do with verbal distractionChildren receive the standard tell-show-do technique with verbal distraction during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6 to 10 years
- Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
- Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
- Children with NO previous exposure to invasive dental procedure
- No prior experience using VR glasses
Key exclusion criteria (6 listed)
- ASA 3 and above
- Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
- Special needs ( intellectual and developmental)
- Children on psychotropic medication
- Children wearing glasses
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 |
|---|---|---|
| Virtual reality headsetChildren wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception. | Device | Arm 1: Virtual Reality Distraction |
| Audio-visual distraction with 2D cartoonsChildren watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception. | Behavioural | Arm 2: Audio-Visual Distraction |
| Tell-show-do with verbal distractionChildren receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation. | Behavioural | Arm 3: Conventional Tell-Show-Do |
Primary outcome
Child Dental Anxiety (Self-Report)
Time frame: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.
Child Dental Anxiety (Observation-based Assessment)
Time frame: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).
3a: Physiological Monitoring - Pulse Rate
Time frame: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age: Preschool children (3-5 years): ~80-120 bpm School-aged children (6-12 years): ~70-118 bpm Adolescents (13-18 years): ~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).
3b: Physiological Monitoring - Oxygen Saturation (SpO₂)
Time frame: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).
2 secondary outcomes
Pain Perception (Self-Report)
Time frame: at the end of the procedure
Child Behavior (Observation)
Time frame: Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure
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 9 Jul 2026.
- Background: PubMed 38087294Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7.
- Background: PubMed 39465519Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.
- Background: PubMed 34300185Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019.
- Royal College of Surgeons of England. (n.d.). Non-pharmacological behavior management in dentistry. The Royal College of Surgeons of England.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations in pediatric populations, privacy concerns, and institutional policy. Only aggregated results will be published in peer-reviewed journals and presented at scientific meetings.
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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.
Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd) contact
Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd) study director
Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,
Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd) study director
Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services
Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI) principal investigator
Oman Medical Specialty Boaered
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset, Audio-visual distraction with 2D cartoons and Tell-show-do with verbal distraction in people with Dental Anxiety in Children and Pain Perception, run by Sultan Qaboos University at 2 sites in Oman.
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 6 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Oman. 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 Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI) (+96895573313, zalqulhati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Dental Anxiety (Self-Report) (time frame: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693764, which also lists 3 linked publications.
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 9 Jul 2026.