Effects of Virtual Reality Content on Anxiety During Third Molar Surgery
13 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
75
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rize Province
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Rize, Rize Province, Турция (Туркие), 53020
- Recep Tayyip Erdogan University Faculty of Dentistry
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
|
|
Экспериментальный: 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.
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|
Без вмешательства: 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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Modified Dental Anxiety Scale Score
Временное ограничение: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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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.
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From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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Change in State-Trait Anxiety Inventory-State Subscale Score
Временное ограничение: 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.
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From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Anxiety Visual Analog Scale Score
Временное ограничение: 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.
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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)
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Change in Systolic Blood Pressure
Временное ограничение: 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)
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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.
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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)
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Change in Diastolic Blood Pressure
Временное ограничение: 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)
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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.
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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)
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Change in Heart Rate
Временное ограничение: 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)
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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.
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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)
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Change in Peripheral Oxygen Saturation
Временное ограничение: 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)
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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.
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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)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 октября 2025 г.
Первичное завершение (Действительный)
30 июня 2026 г.
Завершение исследования (Действительный)
30 июня 2026 г.
Даты регистрации исследования
Первый отправленный
8 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 сентября 2026 г.
Первый опубликованный (Действительный)
14 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2025/353
Планирование данных отдельных участников (IPD)
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ДА
Описание плана 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.
Сроки обмена IPD
Data will be available beginning after publication of the main study results and will remain available for five years following publication.
Критерии совместного доступа к 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .