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NCT Number: NCT07050095

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Abanob M Khalil, M.B.B.CH

PRINCIPAL_INVESTIGATOR

Ahmed F Mohamed, MD

SUB_INVESTIGATOR

Hebatullah S Abdelhamid, MD

CONTACT

[email protected]

002 01044512277

Tamer F Safan, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Group

Other

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

Other names: Guided Meditation VR

Midazolam Group

Drug

Patient will receive midazolam premedication only.

Other names: Midazolam

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Patient Satisfaction

    Time frame: 2 hours Post intervention

    Survey with options: very satisfied, satisfied, undecided, or unsatisfied

  6. Incidence of Complications

    Time frame: First 30 minutes post-extubation

    Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort.

Study contacts

Contact information is provided by the study sponsor or research team.

Hebatullah S Abdelhamid, MD

CONTACT

[email protected]

002 01044512277

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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