Virtual Reality Distraction During Restorative Dental Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Virtual Reality Headset, Standard Dental Treatment.
- Кому может быть актуально
- Состояния в реестре: Dental Anxiety, Pain. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Саудовская Аравия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Impact of Virtual Reality on Pain Perception and Patients' Experience Following the Administration of Local Anesthesia and Restorative Dental Treatment: Split-Mouth Randomized Clinical Trial
Обзор
This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.
Подробное описание
Dental anxiety and pain associated with local anesthesia and restorative procedures remain important barriers to seeking dental care and may negatively affect the overall patient experience. Virtual reality (VR) distraction has emerged as a non-pharmacological intervention that provides immersive audiovisual stimulation and may reduce procedural anxiety and pain by diverting patients' attention from the dental procedure.
This study is designed as a split-mouth randomized clinical trial in adult patients requiring bilateral Class I restorative treatment. Each participant will receive restorative treatment under two conditions: conventional treatment without VR and treatment with VR distraction, with the order of interventions randomized. The split-mouth design allows each participant to serve as their own control, minimizing inter-individual variability.
The primary objectives are to evaluate the effect of VR distraction on anxiety and pain perception during local anesthesia administration and restorative dental treatment. Secondary objectives include assessment of physiological responses (pulse rate, systolic and diastolic blood pressure, and oxygen saturation), patient comfort, unpleasant symptoms, treatment experience, awareness of the clinical surroundings, preference for future VR use, and the influence of VR on dental clinic selection.
The findings will contribute to the evidence regarding the effectiveness of immersive VR as an adjunctive, non-pharmacological approach for improving patient experience during routine restorative dental procedures.
Вмешательства
- Устройство Virtual Reality Headset
Participants will wear an immersive virtual reality headset during local anesthesia administration and restorative dental treatment. The virtual reality intervention is used as a non-pharmacological distraction technique to reduce pain perception and anxiety and to improve the overall patient experience during dental treatment. - Другое Standard Dental Treatment
Participants will receive conventional local anesthesia and restorative dental treatment without virtual reality distraction. All clinical procedures will be performed according to the standard treatment protocol and will serve as the control condition for comparison with the virtual reality intervention.
Первичные конечные точки
- Dental Anxiety [Срок оценки: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.]
- Pain Perception [Срок оценки: Immediately after local anaesthesia administration during each treatment session on day 1.]
Вторичные конечные точки (10)
- Pulse rate [Срок оценки: Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.]
- Systolic blood pressure [Срок оценки: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.]
- Diastolic blood pressure [Срок оценки: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.]
- Oxygen saturation [Срок оценки: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.]
- Patient comfort [Срок оценки: Immediately after completion of each treatment session (Day 1).]
- Unpleasant symptoms [Срок оценки: Immediately after completion of each treatment session (Day 1).]
- Perceived improvement in treatment experience [Срок оценки: Immediately after completion of each treatment session (Day 1).]
- Preference for virtual reality in future dental treatment [Срок оценки: Immediately after completion of both treatment sessions (Day 1).]
- Influence of virtual reality on dental clinic selection [Срок оценки: Immediately after completion of both treatment sessions (Day 1).]
- Awareness of the clinical surroundings [Срок оценки: Immediately after completion of each treatment session (Day 1).]
Критерии участия
Критерии включения
- Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
- Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
- Willing and able to provide written informed consent.
- Willing to participate in the study and comply with study procedures.
Критерии исключения
- Children (<18 years).
- American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
- Deep Class I carious lesions with pulpal involvement.
- Mentally or medically compromised patients.
- Patients presenting with acute dental pain, such as acute pulpitis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Саудовская Аравия · 1 центр
- Professor Muhammad Zubair Ahmad — Ar Rass
Идентификаторы
NCT: NCT07738718 · 26-63-13