Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-01 @ 11:14 AM
Study NCT ID:
NCT04731792
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-02-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)', 'timeFrame': '1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Stress', 'Pain', 'Bronchial Fibroscopy', 'Pulmonary Transplantation']}, 'descriptionModule': {'briefSummary': 'Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.\n\nThe objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.\n\nTranslated with www.DeepL.com/Translator (free version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a lung or cardio-pulmonary transplant\n* Adults (age \\> 18 years old)\n* Patient who give their informed consent for the protocol\n* Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality\n\nExclusion Criteria:\n\n\\- children'}, 'identificationModule': {'nctId': 'NCT04731792', 'acronym': 'REVDOU', 'briefTitle': 'Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Chirurgical Marie Lannelongue'}, 'officialTitle': 'Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.', 'orgStudyIdInfo': {'id': '2020-A00658-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality group', 'interventionNames': ['Other: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'OTHER', 'description': 'a bronchial fibroscopy with a virtual reality helmet', 'armGroupLabels': ['Virtual Reality group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'cecile Degoulet', 'role': 'CONTACT', 'email': 'c.degoulet@ghpsj.fr', 'phone': '01.40.94.25.98'}], 'facility': 'Centre Chirurgical Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}], 'centralContacts': [{'name': 'Cécile DEGOULET', 'role': 'CONTACT', 'email': 'c.degoulet@ghpsj.fr', 'phone': '01 40 94 25 98'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}