NCT07819123

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 8, 2026

Last Update Submit

September 13, 2026

Conditions

Keywords

Virtual RealityImmersive Virtual EnvironmentThird Molar SurgeryOral SurgeryNature-Based Virtual RealityArt-Gallery Virtual RealityNonpharmacological Anxiety Management

Outcome Measures

Primary Outcomes (2)

  • Change in Modified Dental Anxiety Scale Score

    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

    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 Outcomes (5)

  • Change in Anxiety Visual Analog Scale Score

    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

    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

    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

    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

    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)

Study Arms (3)

Nature-Based Virtual Reality

EXPERIMENTAL

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.

Behavioral: Nature-Based Virtual Reality

Art-Gallery Virtual Reality

EXPERIMENTAL

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.

Behavioral: Art-Gallery Virtual Reality

Conventional Care Without Virtual Reality

NO INTERVENTION

Participants underwent the same standardized surgical procedure and received conventional clinical care without a virtual reality headset or an alternative audiovisual intervention.

Interventions

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.

Nature-Based 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. 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.

Art-Gallery Virtual Reality

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Faculty of Dentistry

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1:1 ratio to nature-based virtual reality, art-gallery virtual reality, or conventional care without virtual reality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

October 1, 2025

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article will be made available by the corresponding author upon reasonable request.

Time Frame
Data will be available beginning after publication of the main study results and will remain available for five years following publication.
Access Criteria
Requests should be submitted to the corresponding author at ismailburak.halat@erdogan.edu.tr and should include a scientifically sound research proposal. Requests will be evaluated for compatibility with participant consent, ethics approval, and applicable data-protection requirements. Data will be shared with qualified researchers for approved scientific purposes, and a data-use agreement may be required.

Locations