Actively Recruiting
Randomized Trial Comparing Virtual Reality Immersion and Midazolam Premedication for Anxiety in Dacryocystorhinostomy Surgery
Led by Cairo University · Updated on 2025-07-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of virtual reality immersion versus midazolam premedication on anxiety and blood pressure stability in adult patients undergoing dacryocystorhinostomy (DCR) surgery under general anesthesia. DCR is a procedure to bypass blocked tear ducts, and preoperative anxiety is common due to fears related to surgery and its outcomes. Midazolam is commonly used to reduce anxiety but has side effects and debated benefits, while virtual reality offers a non-drug alternative to ease anxiety. Participants will be randomly assigned to one of two groups: one will experience virtual reality immersion using an Oculus device, and the other will receive midazolam medication before surgery. The study does not mask treatments and compares these approaches directly. The surgery and anesthesia procedures will follow standard care, with the interventions applied prior to the operation. Throughout the study, researchers will measure anxiety levels 15 minutes after the intervention and monitor heart rate and blood pressure for up to two hours after intubation. They will also assess patient satisfaction two hours after the intervention and track any complications within 30 minutes after the breathing tube is removed. The study will enroll adults aged 18 to 65 and continue until December 2025.
CONDITIONS
Brief Title
Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) classification I or II
- Scheduled for dacryocystorhinostomy surgery under general anesthesia
You will not qualify if you...
- Patient refusal to participate
- Presence of cardiac diseases
- Presence of renal diseases
- History of drug sensitivity or seizures
- Substance abuse or addiction
- Claustrophobia
- Cerebrovascular disease
- Psychiatric or cognitive disorders
- Severe teary eyes or blurred vision
- Discomfort expressed during the test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session on the day of surgery
Participants receive either virtual reality immersion using Oculus or midazolam premedication prior to dacryocystorhinostomy surgery to reduce preoperative anxiety.
1 visit (in-person)
Duration - Up to 2 hours after intubation and 30 minutes post-extubation
Participants are monitored for heart rate, blood pressure, patient satisfaction, and any complications following surgery and intervention.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
H
Hebatullah S Abdelhamid, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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