Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-02 @ 2:32 AM
Study NCT ID:
NCT07050095
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Score', 'timeFrame': '15-minute after intervention', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Heart rate (HR)', 'timeFrame': 'After intubation (Up to 2 hours)', 'description': '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).'}, {'measure': 'Systolic blood pressure (SBP)', 'timeFrame': 'After intubation (Up to 2 hours)', 'description': '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).'}, {'measure': 'Diastolic blood pressure (DBP)', 'timeFrame': 'After intubation (Up to 2 hours)', 'description': '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).'}, {'measure': 'Mean blood pressure (MBP)', 'timeFrame': 'After intubation (Up to 2 hours)', 'description': '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).'}, {'measure': 'Patient Satisfaction', 'timeFrame': '2 hours Post intervention', 'description': 'Survey with options: very satisfied, satisfied, undecided, or unsatisfied'}, {'measure': 'Incidence of Complications', 'timeFrame': 'First 30 minutes post-extubation', 'description': 'Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiolytic Effect', 'Virtual Reality Immersion', 'Midazolam', 'Premedication', 'Dacryocystorhinostomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMidazolam 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.\n\nVirtual 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.\n\nDacryocystorhinostomy (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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) classification: I - II.\n* Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patients with cardiac diseases.\n* Patients with renal diseases.\n* Patients with drug sensitivity and seizures.\n* Substance abuse and addiction.\n* Claustrophobia.\n* Patients with cerebrovascular disease.\n* Psychiatric and cognitive disorder.\n* Patients with severe teary eyes and blurring of vision.\n* Patients who express discomfort during the test.'}, 'identificationModule': {'nctId': 'NCT07050095', 'briefTitle': 'Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery', 'orgStudyIdInfo': {'id': 'MS-526-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group', 'description': 'Patient will undergo virtual reality (VR) immersion using oculus.', 'interventionNames': ['Other: Virtual Reality Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam Group', 'description': 'Patient will receive midazolam premedication only.', 'interventionNames': ['Drug: Midazolam Group']}], 'interventions': [{'name': 'Virtual Reality Group', 'type': 'OTHER', 'otherNames': ['Guided Meditation VR'], 'description': 'Patient will undergo virtual reality (VR) immersion using oculus.', 'armGroupLabels': ['Virtual Reality Group']}, {'name': 'Midazolam Group', 'type': 'DRUG', 'otherNames': ['Midazolam'], 'description': 'Patient will receive midazolam premedication only.', 'armGroupLabels': ['Midazolam Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hebatullah S Abdelhamid, MD', 'role': 'CONTACT', 'email': 'drhebasalah593@gmail.com', 'phone': '002 01044512277'}, {'name': 'Tamer F Safan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed F Mohamed, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abanob M Khalil, M.B.B.CH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hebatullah S Abdelhamid, MD', 'role': 'CONTACT', 'email': 'drhebasalah593@gmail.com', 'phone': '002 01044512277'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.', 'investigatorFullName': 'Hebatallah Salah Abdelhamid', 'investigatorAffiliation': 'Cairo University'}}}}