Virtual reality immersion versus midazolam to reduce anxiety before dacryocystorhinostomy
Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
This project will test whether virtual reality immersion can reduce anxiety as well as midazolam in adults having dacryocystorhinostomy under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07050095 on ClinicalTrials.gov |
What this trial studies
Adults undergoing dacryocystorhinostomy under general anesthesia are assigned to either a virtual reality immersion session before surgery or to standard midazolam premedication. The study measures preoperative anxiety levels, intraoperative hemodynamic stability, and records sedation-related adverse events. Virtual reality offers an immersive non-pharmacologic experience, while midazolam acts on GABAA receptors to produce sedation. Outcomes will compare anxiolytic effect and safety to determine if VR can be a viable alternative to drug premedication.
Who should consider this trial
Good fit: Adults aged 18–65 years, ASA class I–II, of any sex, scheduled for dacryocystorhinostomy under general anesthesia are the ideal candidates.
Not a fit: Patients with cardiac or renal disease, seizure disorders, substance abuse, significant psychiatric or cognitive impairment, claustrophobia, severe eye problems, or those who cannot tolerate VR are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, VR could provide a non-drug way to lower preoperative anxiety and reduce sedative-related side effects.
How similar studies have performed: Previous small trials and reviews have shown that virtual reality can reduce perioperative anxiety and pain in various surgical settings, though direct comparisons with midazolam are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Hebatullah S Abdelhamid, MD
- Email: drhebasalah593@gmail.com
- Phone: 002 01044512277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.