Dental AnxietyNCT07738718
Virtual Reality Distraction During Restorative Dental Treatment
A study testing Virtual Reality Headset and Standard Dental Treatment in people with Dental Anxiety and Pain, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Pain
- What is being tested?
- Virtual Reality Headset and Standard Dental Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Aug 2025to 18 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
- Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
- Willing and able to provide written informed consent.
- Willing to participate in the study and comply with study procedures.
Who cannot join
- Children (<18 years).
- American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
- Deep Class I carious lesions with pulpal involvement.
- Mentally or medically compromised patients.
- Patients presenting with acute dental pain, such as acute pulpitis.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Professor Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, 58883
About this study
Official title: The Impact of Virtual Reality on Pain Perception and Patients' Experience Following the Administration of Local Anesthesia and Restorative Dental Treatment: Split-Mouth Randomized Clinical Trial
This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.
Read the detailed description
Dental anxiety and pain associated with local anesthesia and restorative procedures remain important barriers to seeking dental care and may negatively affect the overall patient experience. Virtual reality (VR) distraction has emerged as a non-pharmacological intervention that provides immersive audiovisual stimulation and may reduce procedural anxiety and pain by diverting patients' attention from the dental procedure.
This study is designed as a split-mouth randomized clinical trial in adult patients requiring bilateral Class I restorative treatment. Each participant will receive restorative treatment under two conditions: conventional treatment without VR and treatment with VR distraction, with the order of interventions randomized. The split-mouth design allows each participant to serve as their own control, minimizing inter-individual variability.
The primary objectives are to evaluate the effect of VR distraction on anxiety and pain perception during local anesthesia administration and restorative dental treatment. Secondary objectives include assessment of physiological responses (pulse rate, systolic and diastolic blood pressure, and oxygen saturation), patient comfort, unpleasant symptoms, treatment experience, awareness of the clinical surroundings, preference for future VR use, and the influence of VR on dental clinic selection.
The findings will contribute to the evidence regarding the effectiveness of immersive VR as an adjunctive, non-pharmacological approach for improving patient experience during routine restorative dental procedures.
- Conditions
- Dental Anxiety, Pain
- Being tested
- Virtual Reality Headset, Standard Dental Treatment
- Keywords
- Virtual Reality, Local Anesthesia, Restorative Dentistry, Pain Perception, Patient Experience, Dental Treatment, Split-Mouth Trial, Randomized Clinical Trial
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Participants will wear an immersive virtual reality headset during local anesthesia administration and restorative dental treatment. The virtual reality intervention is used as a non-pharmacological distraction technique to reduce pain perception and anxiety and to improve the overall patient experience during dental treatment.
Standard Dental TreatmentOther
Participants will receive conventional local anesthesia and restorative dental treatment without virtual reality distraction. All clinical procedures will be performed according to the standard treatment protocol and will serve as the control condition for comparison with the virtual reality intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Virtual Reality Distraction | Experimental | Participants will receive local anesthesia and restorative dental treatment while using an immersive virtual reality headset as a distraction intervention. Receives: Device: Virtual Reality Headset |
| Group 2. Conventional Treatment | Active comparator | Participants will receive local anesthesia and restorative dental treatment without virtual reality distraction according to the standard clinical procedure. Receives: Other: Standard Dental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety
Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 (not anxious) to 5 (extremely anxious), with a total score range of 5-25; higher scores indicate greater anxiety.
Measured: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.
Pain Perception
Pain intensity will be measured using a 0-10 cm Visual Analog Scale (VAS) following local anaesthesia administration and will be compared between the virtual reality and conventional treatment conditions. Higher scores indicate more pain.
Measured: Immediately after local anaesthesia administration during each treatment session on day 1.
Secondary outcomes (10)
Pulse rate
Pulse rate (beats per minute) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
Measured: Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.
Systolic blood pressure
Systolic blood pressure (mmHg) will be recorded during dental treatment under virtual reality distraction and conventional treatment.
Measured: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Diastolic blood pressure
Diastolic blood pressure (mmHg) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
Measured: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Oxygen saturation
Peripheral oxygen saturation (SpO₂, %) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
Measured: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Patient comfort
Patient-reported comfort following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire.
Measured: Immediately after completion of each treatment session (Day 1).
Unpleasant symptoms
Patient-reported unpleasant symptoms experienced following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire.
Measured: Immediately after completion of each treatment session (Day 1).
Perceived improvement in treatment experience
Patient-reported perception of the overall dental treatment experience following virtual reality distraction versus conventional treatment, assessed using a structured post-treatment questionnaire.
Measured: Immediately after completion of each treatment session (Day 1).
Preference for virtual reality in future dental treatment
Patient preference for using virtual reality during future dental treatment, assessed after experiencing both virtual reality distraction and conventional treatment using a structured post-treatment questionnaire.
Measured: Immediately after completion of both treatment sessions (Day 1).
Influence of virtual reality on dental clinic selection
Patient-reported willingness to choose a dental clinic offering virtual reality after experiencing both virtual reality distraction and conventional treatment, assessed using a structured post-treatment questionnaire.
Measured: Immediately after completion of both treatment sessions (Day 1).
Awareness of the clinical surroundings
Patient awareness of the clinical surroundings during dental treatment under virtual reality distraction and conventional treatment, assessed using a structured post-treatment questionnaire.
Measured: Immediately after completion of each treatment session (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start25 Aug 2025
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized split-mouth (within-subject) parallel design. This is a randomized split-mouth clinical trial in which the intervention and control will be allocated to two different sides of the mouth within the same participant. Allocation of the intervention side will be determined by randomization. Both interventions will be delivered during the same visit, with no time-based sequence or washout period. Each participant will therefore serve as their own control, receiving both the intervention and control concurrently at different intraoral sites.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Zubair Ahmad, Qassim University
- Investigators
- Abdullah B Altorisy, BDS, Study director, Riyadh Elm University, Saudi ArabiaShahzad A Shah, FCS, Study director, Qassim University, Saudi ArabiaAhmed S Albahoth, PhD, Study director, Qassim University, Saudi ArabiaBilal I Arjumand, FCPS, Study director, Qassim University, Saudi ArabiaAsma M Khan, FCPS, Study director, Qassim University, Saudi ArabiaAnas Abdul khader, MDS, Study chair, Qassim University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738718
- Sponsor's protocol ID
- 26-63-13
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality on Pain Perception and Patients' Experience Following the Administration of Local Anesthesia and Restorative Dental Treatment: Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07738718
- Acronym / sponsor ID
- 26-63-13
- Conditions
- Dental Anxiety, Pain
- Keywords
- Virtual Reality, Local Anesthesia, Restorative Dentistry, Pain Perception, Patient Experience, Dental Treatment, Split-Mouth Trial, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 31 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.
This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.
Detailed description
Dental anxiety and pain associated with local anesthesia and restorative procedures remain important barriers to seeking dental care and may negatively affect the overall patient experience. Virtual reality (VR) distraction has emerged as a non-pharmacological intervention that provides immersive audiovisual stimulation and may reduce procedural anxiety and pain by diverting patients' attention from the dental procedure.
This study is designed as a split-mouth randomized clinical trial in adult patients requiring bilateral Class I restorative treatment. Each participant will receive restorative treatment under two conditions: conventional treatment without VR and treatment with VR distraction, with the order of interventions randomized. The split-mouth design allows each participant to serve as their own control, minimizing inter-individual variability.
The primary objectives are to evaluate the effect of VR distraction on anxiety and pain perception during local anesthesia administration and restorative dental treatment. Secondary objectives include assessment of physiological responses (pulse rate, systolic and diastolic blood pressure, and oxygen saturation), patient comfort, unpleasant symptoms, treatment experience, awareness of the clinical surroundings, preference for future VR use, and the influence of VR on dental clinic selection.
The findings will contribute to the evidence regarding the effectiveness of immersive VR as an adjunctive, non-pharmacological approach for improving patient experience during routine restorative dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized split-mouth (within-subject) parallel design. This is a randomized split-mouth clinical trial in which the intervention and control will be allocated to two different sides of the mouth within the same participant. Allocation of the intervention side will be determined by randomization. Both interventions will be delivered during the same visit, with no time-based sequence or washout period. Each participant will therefore serve as their own control, receiving both the intervention and control concurrently at different intraoral sites.
| Arm | Type | Receives |
|---|---|---|
| Group 1. Virtual Reality Distraction | Experimental | Device: Virtual Reality HeadsetParticipants will receive local anesthesia and restorative dental treatment while using an immersive virtual reality headset as a distraction intervention. |
| Group 2. Conventional Treatment | Active comparator | Other: Standard Dental TreatmentParticipants will receive local anesthesia and restorative dental treatment without virtual reality distraction according to the standard clinical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
- Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
- Willing and able to provide written informed consent.
- Willing to participate in the study and comply with study procedures.
Key exclusion criteria (5 listed)
- Children (<18 years).
- American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
- Deep Class I carious lesions with pulpal involvement.
- Mentally or medically compromised patients.
- Patients presenting with acute dental pain, such as acute pulpitis.
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 HeadsetParticipants will wear an immersive virtual reality headset during local anesthesia administration and restorative dental treatment. The virtual reality intervention is used as a non-pharmacological distraction technique to reduce pain perception and anxiety and to improve the overall patient experience during dental treatment. | Device | Group 1. Virtual Reality Distraction |
| Standard Dental TreatmentParticipants will receive conventional local anesthesia and restorative dental treatment without virtual reality distraction. All clinical procedures will be performed according to the standard treatment protocol and will serve as the control condition for comparison with the virtual reality intervention. | Other | Group 2. Conventional Treatment |
Primary outcome
Dental Anxiety
Time frame: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.
Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 (not anxious) to 5 (extremely anxious), with a total score range of 5-25; higher scores indicate greater anxiety.
Pain Perception
Time frame: Immediately after local anaesthesia administration during each treatment session on day 1.
Pain intensity will be measured using a 0-10 cm Visual Analog Scale (VAS) following local anaesthesia administration and will be compared between the virtual reality and conventional treatment conditions. Higher scores indicate more pain.
10 secondary outcomes
Pulse rate
Time frame: Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.
Systolic blood pressure
Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Diastolic blood pressure
Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Oxygen saturation
Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
Patient comfort
Time frame: Immediately after completion of each treatment session (Day 1).
Unpleasant symptoms
Time frame: Immediately after completion of each treatment session (Day 1).
Perceived improvement in treatment experience
Time frame: Immediately after completion of each treatment session (Day 1).
Preference for virtual reality in future dental treatment
Time frame: Immediately after completion of both treatment sessions (Day 1).
Influence of virtual reality on dental clinic selection
Time frame: Immediately after completion of both treatment sessions (Day 1).
Awareness of the clinical surroundings
Time frame: Immediately after completion of each treatment session (Day 1).
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 27 Oct 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.
Abdullah B Altorisy, BDS study director
Riyadh Elm University, Saudi Arabia
Shahzad A Shah, FCS study director
Qassim University, Saudi Arabia
Ahmed S Albahoth, PhD study director
Qassim University, Saudi Arabia
1 site 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 and Standard Dental Treatment in people with Dental Anxiety and Pain, run by Qassim University at 1 site in Saudi Arabia.
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 5 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 27 Oct 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 Saudi Arabia. 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?
Dental Anxiety (time frame: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.). 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 27 Oct 2026.