Virtual Reality Distraction During Restorative Dental Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Headset, Standard Dental Treatment.
- Who it may be relevant to
- Registry conditions: Dental Anxiety, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Virtual Reality Headset
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. - Other Standard Dental Treatment
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.
Primary outcome measures
- Dental Anxiety [Time frame: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.]
- Pain Perception [Time frame: Immediately after local anaesthesia administration during each treatment session on day 1.]
Secondary outcome measures (10)
- 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).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- Professor Muhammad Zubair Ahmad — Ar Rass
Identifiers
NCT: NCT07738718 · 26-63-13