Dental AnxietyNCT07722221
Effectiveness of Virtual Reality Technique on Children
A study testing Conventional and Virtual reality in people with Dental Anxiety and Pain Management, run by Latakia University at 1 site in Syria.
Trial summary
Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Anxiety, Pain Management, Pediatric Dentistry
- What is being tested?
- Conventional and Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSyria
- Study dates
- 1 May 2021to 12 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6-10 years.
- Physically healthy with no neurological disorders or systemic diseases.
- Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
- Not taking any sedatives or analgesics drugs
Who cannot join
- Uncooperative children who exhibit clear behavioral problems.
- Children with systemic diseases or disorders that may interfere with local anesthesia.
- Use of any medications that may affect vital signs or pain response.
- Presence of infection at the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Technique on Some Vital Signs, Pain and Anxiety Scales During Dental Anaesthesia and Extraction in Children
Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.
Read the detailed description
Local anaesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children.
Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial studied the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients. A total of 64 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of two groups. Pain perception was measured using Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using Venham Picture Test. Vital signs, including pulse rate, oxygen saturation and blood pressure were monitored at baseline and during treatment. Satisfaction levels were assessed for the pediatric patients using child-friendly satisfaction questionnaires
- Conditions
- Dental Anxiety, Pain Management, Pediatric Dentistry
- Being tested
- Conventional, Virtual reality
- Keywords
- Dental extraction, Virtual reality, Local anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalDevice
Behaviour management was done using the conventional techniques (TSD, positive reinforcement) during Local anaesthesia and treatment (extraction)
Virtual realityDevice
Behaviour management was done using Virtual Reality technique during Local anaesthesia and treatment (extraction)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Behaviour management was done using the conventional techniques during Local anaesthesia and extraction Receives: Device: Conventional |
| Virtual Reality | Experimental | Behaviour management was done using virtual reality technique during Local anaesthesia and extraction. Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level during dental anesthesia and treatment
Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain.
Higher scores on either scale indicated greater pain intensity.
Measured: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.
Anxiety level during anesthesia and treatment
Anxiety was assessed using the Venham Picture Test (VPT), a self-reported measure of dental anxiety in children. The scale consists of 8 pairs of drawings, with the child selecting the picture that best reflects their feelings at each pair. Scores range from 0 to 8, where 0 indicates no anxiety and 8 indicates the highest level of anxiety. Higher scores indicate greater anxiety.
Measured: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.
Secondary outcomes (4)
Pulse rate
Pulse rate was measured using a pulse oximeter and recorded in beats per minute (bpm). Readings were recorded at predefined intervals. Increases in heart rate indicated heightened stress or discomfort during the procedure.
Measured: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.]
Oxygen saturation
Peripheral oxygen saturation (SpO₂) was measured using a pulse oximeter and recorded as percentage of oxygen saturation (%). Readings were recorded at predefined intervals. Decreases in SpO2 indicated heightened stress or discomfort during the procedure
Measured: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.
Blood pressure
Blood pressure was measured using an automated blood pressure monitor and recorded as systolic and diastolic blood pressure in millimeters of mercury (mmHg). Higher values indicate higher blood pressure. Changes from baseline were used to assess the physiological response to the dental procedure.
Measured: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.
Patient's satisfaction
Patient satisfaction was assessed using a structured questionnaire with two yes/no questions:
- Are you satisfied with the experience? (Yes/No)
- Would you like to have the same technique in future visits? (Yes/No) Responses were coded as binary outcomes (Yes = 1, No = 0). Higher total scores indicated greater patient satisfaction.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 May 2021
- Primary completion13 Dec 2022
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722221
- Sponsor's protocol ID
- Pediatric LAt
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Technique on Some Vital Signs, Pain and Anxiety Scales During Dental Anaesthesia and Extraction in Children
- ClinicalTrials.gov ID
- NCT07722221
- Acronym / sponsor ID
- Pediatric LAt
- Conditions
- Dental Anxiety, Pain Management, Pediatric Dentistry
- Keywords
- Dental extraction, Virtual reality, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 23 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.
Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.
Detailed description
Local anaesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children.
Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial studied the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients. A total of 64 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of two groups. Pain perception was measured using Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using Venham Picture Test. Vital signs, including pulse rate, oxygen saturation and blood pressure were monitored at baseline and during treatment. Satisfaction levels were assessed for the pediatric patients using child-friendly satisfaction questionnaires
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: ConventionalBehaviour management was done using the conventional techniques during Local anaesthesia and extraction |
| Virtual Reality | Experimental | Device: Virtual realityBehaviour management was done using virtual reality technique during Local anaesthesia and extraction. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-10 years.
- Physically healthy with no neurological disorders or systemic diseases.
- Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
- Not taking any sedatives or analgesics drugs
Key exclusion criteria (4 listed)
- Uncooperative children who exhibit clear behavioral problems.
- Children with systemic diseases or disorders that may interfere with local anesthesia.
- Use of any medications that may affect vital signs or pain response.
- Presence of infection at the injection site.
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 |
|---|---|---|
| ConventionalBehaviour management was done using the conventional techniques (TSD, positive reinforcement) during Local anaesthesia and treatment (extraction) | Device | Control |
| Virtual realityBehaviour management was done using Virtual Reality technique during Local anaesthesia and treatment (extraction) | Device | Virtual Reality |
Primary outcome
Pain level during dental anesthesia and treatment
Time frame: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.
Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain. Higher scores on either scale indicated greater pain intensity.
Anxiety level during anesthesia and treatment
Time frame: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.
Anxiety was assessed using the Venham Picture Test (VPT), a self-reported measure of dental anxiety in children. The scale consists of 8 pairs of drawings, with the child selecting the picture that best reflects their feelings at each pair. Scores range from 0 to 8, where 0 indicates no anxiety and 8 indicates the highest level of anxiety. Higher scores indicate greater anxiety.
4 secondary outcomes
Pulse rate
Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.]
Oxygen saturation
Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.
Blood pressure
Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.
Patient's satisfaction
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and Virtual reality in people with Dental Anxiety and Pain Management, run by Latakia University at 1 site in Syria.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 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 1 site in Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level during dental anesthesia and treatment (time frame: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.). The study lists 2 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 23 Jul 2026.