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

NCT07050095 | Recruiting

• 1 other identifier: MS-526-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anxiety Score

  Beck Anxiety Inventory (BAI) score change measured from pre- to post-intervention (virtual reality (VR) or midazolam). The score ranges from 0 to 63. A greater reduction indicates better anxiolytic effect.5 minutes before intervention and Immediately after the 15-minute virtual reality (VR) session or midazolam injection

  15-minute after intervention

Secondary Outcomes (6)

• Heart rate (HR)

  After intubation (Up to 2 hours)

• Systolic blood pressure (SBP)

  After intubation (Up to 2 hours)

• Diastolic blood pressure (DBP)

  After intubation (Up to 2 hours)

• Mean blood pressure (MBP)

  After intubation (Up to 2 hours)

• Patient Satisfaction

  2 hours Post intervention

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Other: Virtual Reality Group

Midazolam Group

ACTIVE COMPARATOR

Patient will receive midazolam premedication only.

Drug: Midazolam Group

Interventions

Virtual Reality Group OTHER

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

Also known as: Guided Meditation VR

Virtual Reality Group

Midazolam Group DRUG

Patient will receive midazolam premedication only.

Also known as: Midazolam

Midazolam Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hebatullah S Abdelhamid, MD

CONTACT

002 01044512277; drhebasalah593@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)