Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-30 @ 11:50 PM
Study NCT ID:
NCT07013695
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized parallel-group study with two arms (virtual reality group vs. control group) comparing the effect of virtual reality on sedation use during regional anesthesia.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).', 'timeFrame': 'Intraoperative period (from arrival in the operating room to the end of surgery)', 'description': 'Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale.'}], 'secondaryOutcomes': [{'measure': 'Mean age of patients', 'timeFrame': 'Baseline (before anesthesia consultation or at inclusion)', 'description': 'Mean age of patient in each group at baseline'}, {'measure': 'Sex distribution', 'timeFrame': 'Baseline (before anesthesia consultation or at inclusion)', 'description': 'Number of male and female patients in each group'}, {'measure': 'type of surgery', 'timeFrame': 'Baseline (before anesthesia consultation or at inclusion)', 'description': 'Distribution of types of surgery performed in each group'}, {'measure': 'ASA score distribution', 'timeFrame': 'Baseline (before anesthesia consultation or at inclusion)', 'description': 'Distribution of ASA physical status scores among patients in each group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Procedure', 'Anesthesia', 'Sedation']}, 'descriptionModule': {'briefSummary': 'The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Patient affiliated with or benefiting from a social security system\n* Patient aged 18 years or older\n* Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Device interfering with the surgical or anesthetic procedure\n* Premedication before arrival in the operating room\n* Psychiatric or cognitive disorders, communication disorders\n* Patient unable to understand the study (language barrier, psychological issues)\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT07013695', 'acronym': 'VIRTUALR', 'briefTitle': 'Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Eure-Seine'}, 'officialTitle': 'Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery', 'orgStudyIdInfo': {'id': '2022-A00055-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'virtual reality group', 'description': 'Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure.', 'interventionNames': ['Device: Virtual reality headset']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.', 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Virtual reality headset', 'type': 'DEVICE', 'description': 'Patients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure', 'armGroupLabels': ['virtual reality group']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'Participants in this group receive standard anesthetic and surgical care without the use of virtual reality', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27000', 'city': 'Évreux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BEN BEKKOU Lydia', 'role': 'CONTACT', 'email': 'arc2.circe@ch-eureseine.fr', 'phone': '02 32 33 86 75'}, {'name': 'AIDENE Dihia', 'role': 'CONTACT', 'email': 'arc.circe@ch-eureseine.fr', 'phone': '02 32 33 86 75'}], 'facility': 'Centre Hospitalier Eure-Seine', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}], 'centralContacts': [{'name': 'Lydia BEN BEKKOU', 'role': 'CONTACT', 'email': 'arc2.circe@ch-eureseine.fr', 'phone': '02 32 33 86 75'}, {'name': 'Dihia AIDENE', 'role': 'CONTACT', 'email': 'arc.circe@ch-eureseine.fr', 'phone': '02 32 33 86 75'}], 'overallOfficials': [{'name': 'Jean-Baptiste HARDY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Eure-Seine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Eure-Seine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}