Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Group, Midazolam Group.
- Who it may be relevant to
- Registry conditions: Anxiolytic Effect, Virtual Reality Immersion, Midazolam, Premedication. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
Overview
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.
Detailed 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.
Interventions
- Other Virtual Reality Group
Patient will undergo virtual reality (VR) immersion using oculus. - Drug Midazolam Group
Patient will receive midazolam premedication only.
Primary outcome measures
- Anxiety Score [Time frame: 15-minute after intervention]
Secondary outcome measures (6)
- Heart rate (HR) [Time frame: After intubation (Up to 2 hours)]
- Systolic blood pressure (SBP) [Time frame: After intubation (Up to 2 hours)]
- Diastolic blood pressure (DBP) [Time frame: After intubation (Up to 2 hours)]
- Mean blood pressure (MBP) [Time frame: After intubation (Up to 2 hours)]
- Patient Satisfaction [Time frame: 2 hours Post intervention]
- Incidence of Complications [Time frame: First 30 minutes post-extubation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07050095 · MS-526-2023