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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
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.
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.
Professor Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, Saudi Arabia
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.
Time frame: 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.
Time frame: Immediately after local anaesthesia administration during each treatment session on day 1.
Pulse rate
Pulse rate (beats per minute) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
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
Systolic blood pressure (mmHg) will be recorded during dental treatment under virtual reality distraction and conventional treatment.
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
Diastolic blood pressure (mmHg) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.
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Masking
NONE
Enrollment
13
Oxygen saturation
Peripheral oxygen saturation (SpO₂, %) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after completion of each treatment session (Day 1).