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Effects of Virtual Reality Content on Anxiety During Third Molar Surgery

13 września 2026 zaktualizowane przez: 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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

75

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Eksperymentalny: 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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Modified Dental Anxiety Scale Score
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Anxiety Visual Analog Scale Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 października 2025

Zakończenie podstawowe (Rzeczywisty)

30 czerwca 2026

Ukończenie studiów (Rzeczywisty)

30 czerwca 2026

Daty rejestracji na studia

Pierwszy przesłany

8 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 września 2026

Pierwszy wysłany (Rzeczywisty)

14 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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