Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 7:08 AM
Study NCT ID:
NCT04804735
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2021-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean of pain felt during the whole IVAD procedure', 'timeFrame': '1 day', 'description': 'pain means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no pain and 10 the maximum pain feeling.'}, {'measure': 'mean of anxiety felt during the whole IVAD procedure', 'timeFrame': '1 day', 'description': 'Anxiety means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no anxiety and 10 the maximum anxiety feeling.'}], 'secondaryOutcomes': [{'measure': 'Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.', 'timeFrame': '1 day', 'description': 'Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.'}, {'measure': 'Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.', 'timeFrame': '1 day', 'description': 'NRS and responses to the closed questions'}, {'measure': 'Global patient satisfaction of NRS and comparison between the 3 groups.', 'timeFrame': '1 day', 'description': 'patient satisfaction of NRS'}, {'measure': 'Pain NRS means felt during the procedure and comparison.', 'timeFrame': '1 day', 'description': 'NRS means'}, {'measure': 'Anxiety NRS means felt during the procedure and comparison.', 'timeFrame': '1 day', 'description': 'NRS means'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implanted Venous Access Device']}, 'descriptionModule': {'briefSummary': 'Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.', 'detailedDescription': 'Evaluate the efficacy of virtual reality and music therapy on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient aged between 18 and 85 years.\n2. Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.\n3. Absence of anxiolytic premedication.\n4. Patient affiliated to social insurance.\n5. Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.\n6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Patient already participated to this study.\n2. Patient deprived of liberty or under legal representative or under curatorship.\n3. Psychiatric disease enabling communication.\n4. Deafness or visual impairement.\n5. Patient under beta-blockers medication.\n6. Chronic pain present and not equilibrated before the measured procedure as \\> 3 by the NRS.\n7. Tracheotomy.\n8. Low cervical tumor, or bilateral low cervical adenopathies.\n9. Compression or jugular stenosis (uni or bilateral).\n10. Jugular or subclavian thrombosis.\n11. Patient under anticoagulants medication or having hesmostasis troubles.\n12. Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.\n13. Patients not speaking french.\n14. Pregnant and breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT04804735', 'acronym': 'REVCCI', 'briefTitle': 'Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia', 'orgStudyIdInfo': {'id': 'IC 2020-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REV : local anesthesia and virtual reality', 'description': 'Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia', 'interventionNames': ['Device: REV : local anesthesia and virtual reality']}, {'type': 'EXPERIMENTAL', 'label': 'MUS : local anesthesia and music therapy', 'description': 'Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia', 'interventionNames': ['Device: MUS : local anesthesia and music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL : standard local anesthesia', 'description': 'Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care'}], 'interventions': [{'name': 'REV : local anesthesia and virtual reality', 'type': 'DEVICE', 'description': 'REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia', 'armGroupLabels': ['REV : local anesthesia and virtual reality']}, {'name': 'MUS : local anesthesia and music therapy', 'type': 'DEVICE', 'description': 'MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia', 'armGroupLabels': ['MUS : local anesthesia and music therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Steven LE GOUILL, Pr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Curie'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}