- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819123
Effects of Virtual Reality Content on Anxiety During Third Molar Surgery
A Comparative Evaluation of the Effects of Different Virtual Reality (VR) Content on Patient Anxiety During Impacted Mandibular Third Molar Surgery
This randomized controlled study evaluated whether the content of an immersive virtual reality environment influenced anxiety in adults undergoing surgical removal of an impacted mandibular third molar. A total of 75 patients aged 18-40 years with elevated dental anxiety were randomly assigned in a 1:1:1 ratio to a nature-based virtual reality group, an art-gallery virtual reality group, or a control group receiving conventional care without virtual reality.
Participants in the two virtual reality groups wore the same headset and headphones and viewed standardized 360-degree content from the beginning of surgery until completion of the procedure. Anxiety was assessed using the Modified Dental Anxiety Scale, the State-Trait Anxiety Inventory-State subscale, and an 11-point numerical anxiety rating scale. Systolic and diastolic blood pressure, heart rate, and peripheral oxygen saturation were also recorded. Measurements were obtained before local anesthesia, after local anesthesia but before surgery and virtual reality exposure, and immediately after wound closure, as applicable. The study compared changes in anxiety and physiological measures among the three groups and examined whether nature-based and art-gallery virtual reality content produced different responses.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rize Province
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Rize, Rize Province, Turkey (Türkiye), 53020
- Recep Tayyip Erdogan University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 40 years
- American Society of Anesthesiologists (ASA) physical status I
- Presence of an impacted mandibular third molar for which surgical removal was indicated
- Pell and Gregory Class II, position B impaction
- Vertical or mesioangular impaction according to Winter's classification
- Preoperative Modified Dental Anxiety Scale (MDAS) score of 11 or higher
- Ability to understand the study procedures and complete the questionnaires
- Provision of written informed consent
Exclusion Criteria:
- A systemic or psychiatric condition considered likely to influence anxiety responses
- Regular use of medication that could alter anxiety or autonomic responses
- Use of antipsychotic or anxiolytic medication
- Smoking 10 or more cigarettes per day
- Previous surgical removal of an impacted tooth
- Acute infection in the operative region
- Pregnancy
- Severe visual or hearing impairment that could prevent adequate virtual reality exposure
- Inability to tolerate or correctly use the virtual reality headset
- Surgical duration exceeding 30 minutes
- Withdrawal of consent at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature-Based Virtual Reality
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones from the beginning of surgery until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
|
Experimental: Art-Gallery Virtual Reality
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
Exposure continued from the beginning of surgery until completion of the procedure and did not exceed 30 minutes.
|
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
|
|
No Intervention: Conventional Care Without Virtual Reality
Participants underwent the same standardized surgical procedure and received conventional clinical care without a virtual reality headset or an alternative audiovisual intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Modified Dental Anxiety Scale Score
Time Frame: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
Dental anxiety was assessed using the five-item Modified Dental Anxiety Scale (MDAS).
Each item is scored from 1 to 5, producing a total score ranging from 5 to 25, with higher scores indicating greater dental anxiety.
The outcome was the change in total MDAS score from T0 to T2, calculated as the T2 score minus the T0 score.
|
From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
|
Change in State-Trait Anxiety Inventory-State Subscale Score
Time Frame: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State subscale (STAI-S).
Each item is scored from 1 to 4, producing a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
The outcome was the change in total STAI-S score from T0 to T2, calculated as the T2 score minus the T0 score.
|
From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Visual Analog Scale Score
Time Frame: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Momentary anxiety was assessed using the study-designated Anxiety Visual Analog Scale (VAS-A), administered as an 11-point whole-number response scale ranging from 0 to 10.
A score of 0 indicated no anxiety, whereas a score of 10 indicated the highest perceived anxiety.
Changes in VAS-A scores across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Systolic Blood Pressure
Time Frame: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Systolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in systolic blood pressure across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Diastolic Blood Pressure
Time Frame: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Diastolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in diastolic blood pressure across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Heart Rate
Time Frame: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Heart rate was measured in beats per minute (bpm) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in heart rate across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
|
Change in Peripheral Oxygen Saturation
Time Frame: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Peripheral oxygen saturation was measured as a percentage (SpO2) using the same monitoring device during a standardized five-minute assessment period at each time point.
Changes in peripheral oxygen saturation across T0, T1, and T2 were compared among the study groups.
|
At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/353
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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