Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT05815056
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'the participation in one of the 2 arms is determined randomly just before the implantation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1 arm with anaesthetic drugs vs hypnosis induced by virtual reality'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful implantation of a veinous access device', 'timeFrame': 'immediately after surgery', 'description': 'we evaluate if the veinous access was implanted successfully with digital or drug sedation'}], 'secondaryOutcomes': [{'measure': 'patient comfort', 'timeFrame': 'during the surgery', 'description': 'we evaluate if the patient needed additional pain killers during the procedure'}, {'measure': 'implantation lenght', 'timeFrame': 'during the surgery', 'description': 'we evaluate the length of the implantation in minutes with the drug or digital sedation'}, {'measure': 'feeling lenght', 'timeFrame': 'immediately after the surgery', 'description': 'we evaluate the length of the implantation felt by the patient using drug or digital sedation'}, {'measure': 'post operative anxiety using the hamilton anxiety scale', 'timeFrame': '2 days after the surgery', 'description': 'we do a post operative test to evaluate the level of anxiety after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central veinous catheter', 'virtual reality induced hypnosis'], 'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:\n\n• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.\n\nParticipants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.\n\nIf there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.', 'detailedDescription': 'This study has two arms. All patients has the same preparation to surgery. They had lorazepam 2.5 mg 30 minutes before the surgery. In operative theater, they are randomly chosen between anesthetic protocol (sufentanyl 5mg intravenous) or digital sedation (Sedakit(R) ) with hypnosis induced by virtual reality.\n\nPatients complete an anxiety test (hamilton scale) 2 days before the surgery and 2 days after the surgery. They are called by an external psychiatrist 1 day before the surgery and 3 days after to evaluate the anxiety link to the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* need for a venous device implantation\n\nExclusion Criteria:\n\n* need for a general anaesthesia\n* unability to give oral consent\n* under 18 years'}, 'identificationModule': {'nctId': 'NCT05815056', 'briefTitle': 'Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Regional de Huy'}, 'officialTitle': 'Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation', 'orgStudyIdInfo': {'id': '2022 PAC RV vs sed med'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'drug intervention', 'description': 'drug induced sedation', 'interventionNames': ['Drug: drug intervention']}, {'type': 'EXPERIMENTAL', 'label': 'digital sedation', 'description': 'hypnosis induced by a virtual reality device', 'interventionNames': ['Device: Sedakit (R) using hypnosis induced by the virtual reality device']}], 'interventions': [{'name': 'Sedakit (R) using hypnosis induced by the virtual reality device', 'type': 'DEVICE', 'otherNames': ['Oncomfort'], 'description': 'we use the virtual reality device and no medication during the surgery', 'armGroupLabels': ['digital sedation']}, {'name': 'drug intervention', 'type': 'DRUG', 'otherNames': ['medical sedation'], 'description': 'using sufentanyl 5mg intravenously during the surgery', 'armGroupLabels': ['drug intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4500', 'city': 'Huy', 'country': 'Belgium', 'facility': 'CHR de Huy', 'geoPoint': {'lat': 50.51894, 'lon': 5.23284}}], 'overallOfficials': [{'name': 'JeanFrancois Maillart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR de Huy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'the data will be available after the official publication for one year', 'ipdSharing': 'YES', 'description': 'an article will be published with the results. the results will probably be exposed in a future congress.', 'accessCriteria': 'official asking and scientific interest in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Regional de Huy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}