Идёт набор NCT07050095

Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery

Без фазы С лечением Anxiolytic Effect Virtual Reality Immersion Midazolam Premedication

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 Group, Midazolam Group.
Кому может быть актуально: Состояния в реестре: Anxiolytic Effect, Virtual Reality Immersion, Midazolam, Premedication. Базовые параметры: 18 лет — 65 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: Египет
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

Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery

Обзор

The aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication.

Подробное описание

Anxiety is a negative emotion characterized by fear, tension, and nervousness. Preoperative anxiety is anxiety due to disease, hospitalization, or scheduled surgery. The most common causes of preoperative anxiety are waiting for surgery, worrying about the operation outcome, being separated from family, anticipating postoperative pain, losing independence, and being afraid of surgery, pain, and death.

Midazolam reduces anxiety by acting on GABAA receptors, resulting in sedation; however, the benefit of midazolam premedication remains debatable, and the drug's side effects include paradoxical reactions, oversedation, reduced blood pressure, and respiratory depression. Regarding this, some clinicians challenge the clinical benefits of benzodiazepine premedication and contend that non-pharmacological treatments alone are sufficient to minimize preoperative anxiety.

Virtual reality is a computer technology that creates the sensation of being immersed in a simulated three-dimensional environment in which the user can interact with the virtual environment. It has also been suggested as a non-pharmaceutical alternative for lowering surgical pain and anxiety.

Dacryocystorhinostomy (DCR) is a procedure that circumvents the blocked tear duct and offers an alternate path for the drainage of tears from the eye to the nose and is most effectively performed under a general anesthetic.

Вмешательства

Другое Virtual Reality Group
Patient will undergo virtual reality (VR) immersion using oculus.
Препарат Midazolam Group
Patient will receive midazolam premedication only.

Первичные конечные точки

Anxiety Score [Срок оценки: 15-minute after intervention]

Вторичные конечные точки (6)

Heart rate (HR) [Срок оценки: After intubation (Up to 2 hours)]
Systolic blood pressure (SBP) [Срок оценки: After intubation (Up to 2 hours)]
Diastolic blood pressure (DBP) [Срок оценки: After intubation (Up to 2 hours)]
Mean blood pressure (MBP) [Срок оценки: After intubation (Up to 2 hours)]
Patient Satisfaction [Срок оценки: 2 hours Post intervention]
Incidence of Complications [Срок оценки: First 30 minutes post-extubation]

Критерии участия

Критерии включения

Aged 18-65.
Both sexes.
American Society of Anesthesiologists (ASA) classification: I - II.
Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.