Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 9:27 PM
Study NCT ID:
NCT07450456
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality on the Need of Premedication Before Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention', 'timeFrame': 'Up to the initiation of pre-oxygenation (same day)'}], 'secondaryOutcomes': [{'measure': 'Richmond Agitation Sedation Score (RAAS)', 'timeFrame': 'Prior to initiation of pre-oxygenation (intraoperative period, same day)', 'description': 'The Richmond Agitation-Sedation Scale (RASS) will be used to assess the level of agitation and sedation in study participants. RASS is a validated 10-point scale ranging from -5 (unarousable) to +4 (combative), with 0 representing alert and calm. Negative scores indicate increasing levels of sedation, while positive scores indicate increasing agitation.'}, {'measure': 'Evaluation of Pa02 and PaC02 in theater', 'timeFrame': 'Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)', 'description': 'In the operative room, Pa02 and PaC02 (both in mmHg) will be extracted from the first arterial blood gas after insertion of arterial line while the patient is not under oxygen'}, {'measure': "External evaluation of patient's comfort", 'timeFrame': 'At end of induction, after airway securement (same day)', 'description': "External evaluation by the anesthetist team of preceived patient's comfort in theater with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived comfort"}, {'measure': 'Post-operative qualitative survey', 'timeFrame': "From 4 hours after patient's extubation up to 72 hours after patient's extubation", 'description': "At least 4 hours after the end of anesthesia and patient's extubation, a qualitative survey will be conducted on patient's experience in the preoperative period"}, {'measure': 'Compliance with the VR intervention', 'timeFrame': 'From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)', 'description': 'Proportion of patients who required the interruption of the VR intervention'}, {'measure': "Post-operative evaluation of patient's satisfaction regarding pre-operative period", 'timeFrame': "From 4 hours after patient's extubation up to 72 hours after patient's extubation", 'description': "Evaluation of patient's satisfaction regarding the pre-operative period with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived level of satisfaction"}, {'measure': 'Incidence of cyberslckness', 'timeFrame': 'From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention', 'description': 'Symptoms of cybersickness such as disorientation, dizziness, eye problems (fatigue, blurred vision, headache) will be monitored'}, {'measure': 'Incidence of secondary effects linked to the use of anxiolytic premedication', 'timeFrame': 'From administration of anxiolytic medication until initiation of pre-oxygenation (same day)', 'description': 'For patients requesting a premedication, secondary effects like cognitive impairment, sedation, respiratory depressions will be registered'}, {'measure': 'Time to Administration of Anxiolytic Premedication', 'timeFrame': 'Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.', 'description': 'After the study intervention, patient will be asked if he still wants to assume anxiolytic premedication. In case of positive answer, anxiolytic premedication will be given and time will be noted. In case of negative answer, no anxiolytic premedication will be given. In the following moments, in case of change in patient\'s anxiety level with a secondary request of anxiolytic premedication, "rescue" premedication will be given and timing will be noted.'}, {'measure': "Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA)", 'timeFrame': 'From immediately before VR session to operating room entry (same day)', 'description': 'Change in Visual Analogue Scale for anxiety (VASA) between 3 time points. VASA scale ranges from 0 to10 with 10 corresponding to the highest level of anxiety.'}, {'measure': "Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS)", 'timeFrame': 'From immediately before VR session to operating room entry (same day)', 'description': 'Change in APAIS scale between 3 time points. APAIS score is a validated score to evaluate anxiety in the preoperative context. It ranges from 6 to 30 with the highest score corresponding to a high level of anxiety.'}, {'measure': 'Change in blood pressure over time', 'timeFrame': 'From immediately before VR session to operating room entry (same day)', 'description': 'Variation of blood pressure (systolic arterial pressure, diastolic arterial pressure, mean arterial pressure) between 3 time points.'}, {'measure': 'Change in oxygen saturation over time', 'timeFrame': 'From immediately before VR session to operating room entry (same day)', 'description': 'Variation of oxygen saturation measured with finger pulsoxymeter between three time points.'}, {'measure': 'Change in heart rate over time', 'timeFrame': 'From immediately before VR session to operating room entry (same day)', 'description': 'Variation of heart rate measured between three time points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Premedication', 'Surgery', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing elective surgery\n* Minimal age of 18-year-old\n* Able to give informed consent for the study\n* Requesting pharmacological premedication in the pre-operative period.\n\nExclusion Criteria:\n\n* Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol\n* Contraindications to pharmacological premedication\n* Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy\n* Non Italian speaking patients\n* Injuries to the head/face that would prohibit wearing headsets\n* Infectious skin conditions of the head/face\n* Contact isolation due to bacteria and viruses\n* Symptoms of vertigo or motion sickness\n* Reduced visual or auditory acuity\n* Pregnancy\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT07450456', 'briefTitle': 'Effect of Virtual Reality on the Need of Premedication Before Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': 'Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery', 'orgStudyIdInfo': {'id': 'ID 2025-01864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality arm', 'interventionNames': ['Device: Virtual Reality']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': "The study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible.", 'armGroupLabels': ['Virtual reality arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6900', 'city': 'Lugano', 'state': 'Canton Ticino', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Hervé Schlotterbeck, Medical Doctor', 'role': 'CONTACT', 'email': 'herve.schlotterbeck@eoc.ch', 'phone': '0041 91 811 51 89'}, {'role': 'CONTACT', 'phone': '0041 91 811 50 00'}], 'facility': 'Istituto Cardiocentro', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Hervé Schlotterbeck, Medical Doctor', 'role': 'CONTACT', 'email': 'herve.schlotterbeck@eoc.ch', 'phone': '0041 91 811 51 89'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Schlotterbeck Hervé', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}