Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 6:19 AM
Study NCT ID:
NCT05588232
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2022-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, prospective, comparative, randomized, open-label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum pain during the interventional cardiology procedures', 'timeFrame': '1 day', 'description': 'measured on a scale of 0 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality', 'Drug Sedation', 'Coronarography', 'Angiography']}, 'descriptionModule': {'briefSummary': 'Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.\n\nThe objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)\n* Affiliation to a social security scheme or beneficiary of such a scheme.\n* Patient having signed the free and informed consent\n\nExclusion Criteria:\n\n* Dementia\n* Language barrier\n* Claustrophobia\n* Nausea\n* History of intolerance to Virtual Reality\n* Patient with epilepsy\n* Refusal to participate in the study\n* Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision\n* Pregnant, breastfeeding or parturient woman\n* Unstable patient (state of shock, respiratory or neurological distress)'}, 'identificationModule': {'nctId': 'NCT05588232', 'acronym': 'VirtuCardio', 'briefTitle': 'the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Elsan'}, 'officialTitle': 'Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures', 'orgStudyIdInfo': {'id': '2021-A01130-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with virtual reality', 'description': 'The virtual reality sedation-analgesia solution developed by Deepsen combines 3D environment content with medical hypnosis techniques. The technology includes a wearable visual headset that contains head movement sensors, enabling patient interaction in the virtual environment, as well as isolating headphones.', 'interventionNames': ['Procedure: scheduled outpatient interventions in interventional cardiology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient with pharmacological sedation', 'interventionNames': ['Procedure: scheduled outpatient interventions in interventional cardiology']}], 'interventions': [{'name': 'scheduled outpatient interventions in interventional cardiology', 'type': 'PROCEDURE', 'description': 'coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)', 'armGroupLabels': ['Patient with pharmacological sedation', 'Patient with virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57070', 'city': 'Metz', 'country': 'France', 'facility': 'Clinique Claude Bernard', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}