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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Group | Experimental | Patient will undergo virtual reality (VR) immersion using oculus. |
|
| Midazolam Group | Active Comparator | Patient will receive midazolam premedication only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Group | Other | Patient will undergo virtual reality (VR) immersion using oculus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After intubation (Up to 2 hours) |
| Systolic blood pressure (SBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hebatullah S Abdelhamid, MD | Contact | 002 01044512277 | drhebasalah593@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
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| Midazolam Group | Drug | Patient will receive midazolam premedication only. |
|
|
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) | 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) | 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 | Survey with options: very satisfied, satisfied, undecided, or unsatisfied | 2 hours Post intervention |
| Incidence of Complications | Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort. | First 30 minutes post-extubation |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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