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
Tamer F Safan, MD
SUB_INVESTIGATOR
NCT Number: NCT07050095
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
Abanob M Khalil, M.B.B.CH
PRINCIPAL_INVESTIGATOR
Ahmed F Mohamed, MD
SUB_INVESTIGATOR
Hebatullah S Abdelhamid, MD
CONTACT
Tamer F Safan, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will undergo virtual reality (VR) immersion using oculus.
Other names: Guided Meditation VR
Patient will receive midazolam premedication only.
Other names: Midazolam
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
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).
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).
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).
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).
Time frame: 2 hours Post intervention
Survey with options: very satisfied, satisfied, undecided, or unsatisfied
Time frame: First 30 minutes post-extubation
Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
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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