Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 12:50 AM
Study NCT ID:
NCT05860192
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Mindfulness in Preoperative Anxious Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from one week before surgery in anxiety on STAI score some hours before the intervention', 'timeFrame': 'Up to two weeks', 'description': 'The State-Trait Anxiety Inventory (STAI) score is a validated, self reported instrument to assessing state and trait anxiety. Possible scores range from "no or low anxiety" (20-37) to "high anxiety" (45-80). Change = (one week before - some hours before the surgery and after mindfulness in virtual reality)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Test Anxiety', 'Anxiety State', 'Preoperative Period']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to reduce preoperative anxiety by Virtual Reality mindfulness.\n\nPopulation: all adults, able to give their consent and scheduled for surgery with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) score \\> 10. The study will recruit 100 patients in one university teaching hospital.\n\nThe main question it aims to answer is: may mindfulness by Virtual Reality reduce preoperative anxiety in patients particularly anxious for the surgery? Participants will be asked to undergo to a single mindfulness virtual reality session before the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults able to give their consent, scheduled for elective surgery and with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) \\> 10\n\nExclusion Criteria:\n\n* Pregnancy\n* Epilepsy\n* Pacemaker wearers\n* Mental diseases\n* Alcohol or drug addiction\n* Severe hearing loss or blindness\n* Simultaneous participation to other studies'}, 'identificationModule': {'nctId': 'NCT05860192', 'briefTitle': 'Virtual Reality Mindfulness in Preoperative Anxious Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Regionale di Mendrisio'}, 'officialTitle': 'Virtual Reality Mindfulness in Preoperative Anxious Patients', 'orgStudyIdInfo': {'id': 'APolito1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Each patient undergoes to a virtual reality session of mindfullness. This lasts about 30 minutes.', 'interventionNames': ['Device: Virtual Reality', 'Other: application for mindfulness']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'otherNames': ['Meta, Oculus 2'], 'description': 'Use of this virtual reality headset to deliver a single mindfulness session', 'armGroupLabels': ['Virtual Reality']}, {'name': 'application for mindfulness', 'type': 'OTHER', 'otherNames': ['Guided Meditation VR'], 'description': 'Application used to realize mindfulness in virtual reality', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6850', 'city': 'Mendrisio', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Andrea Polito', 'role': 'CONTACT', 'email': 'andrea.polito@eoc.ch', 'phone': '0918113510'}], 'facility': 'Andrea Polito', 'geoPoint': {'lat': 45.87019, 'lon': 8.9816}}], 'centralContacts': [{'name': 'Andrea Polito', 'role': 'CONTACT', 'email': 'andrea.polito@eoc.ch', 'phone': '0918113510'}], 'overallOfficials': [{'name': 'Andrea Polito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Beata Vergine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Regionale di Mendrisio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia Clinical Professor, Principal Investigator', 'investigatorFullName': 'Andrea Polito', 'investigatorAffiliation': 'Ospedale Regionale di Mendrisio'}}}}