Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:22 PM
Study NCT ID:
NCT06799806
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-center, prospective, interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety assessment', 'timeFrame': 'Immediately after intervention', 'description': 'Anxiety assessment is measured using a Numerical Rating Scale (NRS) from 0 to 10, supplemented by a self-assessment questionnaire before and after using the Therapeutic Virtual Reality Headset.'}], 'secondaryOutcomes': [{'measure': 'Assessment of bronchoscopy realisation and sample collection', 'timeFrame': 'Immediately after intervention', 'description': 'Assessment of whether bronchoscopy has been performed correctly in the vigile state, aas well as any sampling required, using a questionnaire completed by the nurse present during vigile flexible bronchoscopy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality headset', 'anxiety'], 'conditions': ['Bronchial Fibroscopy']}, 'descriptionModule': {'briefSummary': "Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.\n\nInvestigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.\n\nA great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.\n* In whom bronchial fibroscopy is indicated.\n* Person affiliated with or benefiting from a social security .\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).\n* Patient able and willing to answer questionnaires\n\nExclusion Criteria:\n\n* Patient refusing to participate in research\n* Patient who has already undergone bronchoscopy in vigil\n* Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)\n* Patients with a history of epilepsy or psychiatric pathology\n* Patient with vertigo\n* Patient uncooperative, demented or unable to tolerate headgear.\n* patient under guardianship or curatorship\n* Patients suffering from blindness or deafness\n* Patient with known significant intolerance to screens and/or virtual reality devices\n* Pregnant, nursing or parturient women\n* Unscheduled patients: emergencies, etc.\n* Hospitalized patients'}, 'identificationModule': {'nctId': 'NCT06799806', 'acronym': 'REVA', 'briefTitle': 'The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil', 'orgStudyIdInfo': {'id': 'CHM-2024/S15/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality', 'description': 'virtual reality headset', 'interventionNames': ['Device: virtual reality device']}], 'interventions': [{'name': 'virtual reality device', 'type': 'DEVICE', 'description': '20 minutes session with virtual reality device', 'armGroupLabels': ['virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle JADEAU, MD', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '+332 44 71 07 81'}, {'name': 'Christine PETIT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '+332 44 71 07 81'}], 'overallOfficials': [{'name': 'Christine PETIT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Mans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}