Dental Anxiety, Pain
Conditions
Keywords
Virtual Reality, Local Anesthesia, Restorative Dentistry, Pain Perception, Patient Experience, Dental Treatment, Split-Mouth Trial, Randomized Clinical Trial
Brief 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. 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
DEVICEVirtual 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.
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.
Sponsors
Qassim University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Because of the nature of the intervention, participants and the treating dentist can not be blinded to the use of virtual reality. Outcomes will be collected following each treatment session.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate | Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1. | Pulse rate (beats per minute) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment. |
| Systolic blood pressure | Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1. | Systolic blood pressure (mmHg) will be recorded during dental treatment under virtual reality distraction and conventional treatment. |
| Diastolic blood pressure | Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1. | Diastolic blood pressure (mmHg) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment. |
| Oxygen saturation | Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1. | Peripheral oxygen saturation (SpO₂, %) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment. |
| Patient comfort | Immediately after completion of each treatment session (Day 1). | Patient-reported comfort following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire. |
| Unpleasant symptoms | Immediately after completion of each treatment session (Day 1). | Patient-reported unpleasant symptoms experienced following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire. |
| Perceived improvement in treatment experience | Immediately after completion of each treatment session (Day 1). | Patient-reported perception of the overall dental treatment experience following virtual reality distraction versus conventional treatment, assessed using a structured post-treatment questionnaire. |
| Preference for virtual reality in future dental treatment | Immediately after completion of both treatment sessions (Day 1). | 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. |
| Influence of virtual reality on dental clinic selection | Immediately after completion of both treatment sessions (Day 1). | 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. |
| Awareness of the clinical surroundings | Immediately after completion of each treatment session (Day 1). | Patient awareness of the clinical surroundings during dental treatment under virtual reality distraction and conventional treatment, assessed using a structured post-treatment questionnaire. |
Countries
Saudi Arabia
Outcome results
None listed