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

Cairo University (CU)

Status: Enrolling

Conditions: Premedication; Anxiolytic Effect; Midazolam; Virtual Reality Immersion; Dacryocystorhinostomy

Treatments: Drug: Midazolam Group; Other: Virtual Reality Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07050095

MS-526-2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patient refusal.
• Patients with cardiac diseases.
• Patients with renal diseases.
• Patients with drug sensitivity and seizures.
• Substance abuse and addiction.
• Claustrophobia.
• Patients with cerebrovascular disease.
• Psychiatric and cognitive disorder.
• Patients with severe teary eyes and blurring of vision.
• Patients who express discomfort during the test.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

Patient will undergo virtual reality (VR) immersion using oculus.

Treatment:

Other: Virtual Reality Group

Midazolam Group

Active Comparator group

Description:

Patient will receive midazolam premedication only.

Treatment:

Drug: Midazolam Group