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

ConditionsAnxiolytic EffectVirtual Reality ImmersionMidazolamPremedicationDacryocystorhinostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-65.

Both sexes.

American Society of Anesthesiologists (ASA) classification: I - II.

Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.

Disqualifiers

Patient refusal.

Patients with cardiac diseases.

Patients with renal diseases.

Patients with drug sensitivity and seizures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Group

    Other intervention

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

  • Midazolam Group

    Drug

    Patient will receive midazolam premedication only.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Midazolam GroupActive comparator 1 intervention

Trial outcomes

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

Time frame
15-minute after intervention

Secondary outcomes

1

Heart rate (HR)

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).

Time frame
After intubation (Up to 2 hours)
2

Systolic blood pressure (SBP)

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).

Time frame
After intubation (Up to 2 hours)
3

Diastolic blood pressure (DBP)

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).

Time frame
After intubation (Up to 2 hours)
4

Mean blood pressure (MBP)

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).

Time frame
After intubation (Up to 2 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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