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

June 25, 2025 updated by: Hebatallah Salah Abdelhamid, Cairo University

Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Recruiting
        • Cairo University
        • Contact:
        • Sub-Investigator:
          • Tamer F Safan, MD
        • Sub-Investigator:
          • Ahmed F Mohamed, MD
        • Principal Investigator:
          • Abanob M Khalil, M.B.B.CH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Patient will undergo virtual reality (VR) immersion using oculus.
Other: Virtual Reality Group
Patient will undergo virtual reality (VR) immersion using oculus.
Other Names:
  • Guided Meditation VR
Active Comparator: Midazolam Group
Patient will receive midazolam premedication only.
Drug: Midazolam Group
Patient will receive midazolam premedication only.
Other Names:
  • Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Score
Time Frame: 15-minute after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate (HR)
Time Frame: After intubation (Up to 2 hours)
Heart rate (HR) measured to assess perioperative hemodynamic response to anxiolytic intervention.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
After intubation (Up to 2 hours)
Systolic blood pressure (SBP)
Time Frame: After intubation (Up to 2 hours)
Systolic blood pressure (SBP) recorded to evaluate cardiovascular response to premedication and induction.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
After intubation (Up to 2 hours)
Diastolic blood pressure (DBP)
Time Frame: After intubation (Up to 2 hours)
Diastolic blood pressure (DBP) measured to monitor hemodynamic changes related to stress and sedation.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
After intubation (Up to 2 hours)
Mean blood pressure (MBP)
Time Frame: After intubation (Up to 2 hours)
Mean blood pressure (MBP) recorded to reflect overall perfusion pressure during perioperative period.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
After intubation (Up to 2 hours)
Patient Satisfaction
Time Frame: 2 hours Post intervention
Survey with options: very satisfied, satisfied, undecided, or unsatisfied
2 hours Post intervention
Incidence of Complications
Time Frame: First 30 minutes post-extubation
Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort.
First 30 minutes post-extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

June 25, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-526-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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