Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effects of Virtual Reality Content on Anxiety During Third Molar Surgery

13. september 2026 opdateret af: İsmail Burak HALAT, Recep Tayyip Erdogan University

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rize Province
      • Rize, Rize Province, Tyrkiet (Türkiye), 53020
        • Recep Tayyip Erdogan University Faculty of Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Modified Dental Anxiety Scale Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Anxiety Visual Analog Scale Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Faktiske)

30. juni 2026

Studieafslutning (Faktiske)

30. juni 2026

Datoer for studieregistrering

Først indsendt

8. september 2026

Først indsendt, der opfyldte QC-kriterier

8. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Data will be available beginning after publication of the main study results and will remain available for five years following publication.

IPD-delingsadgangskriterier

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner