Effects of Virtual Reality Content on Anxiety During Third Molar Surgery
13 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Rize Province
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Rize, Rize Province, Turquía (Türkiye), 53020
- Recep Tayyip Erdogan University Faculty of Dentistry
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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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.
|
|
Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Modified Dental Anxiety Scale Score
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Anxiety Visual Analog Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Change in Diastolic Blood Pressure
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2025
Finalización primaria (Actual)
30 de junio de 2026
Finalización del estudio (Actual)
30 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
14 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2025/353
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available beginning after publication of the main study results and will remain available for five years following publication.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .