Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-28 @ 7:40 AM
Study NCT ID:
NCT05592132
Status:
UNKNOWN
Last Update Posted:
2023-10-02
First Post:
2022-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality in Pain Management in Pediatric Oncology
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'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intervention plus standard care versus standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self pain evaluation', 'timeFrame': 'before blood sampling on catheter with implantable chamber', 'description': 'Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Tumor']}, 'descriptionModule': {'briefSummary': 'DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who tolerates the virtual reality headset\n* patient followed in pediatric oncology\n* patient with a diagnosis of benign tumor or cancer\n* patient who needs to have painful medical procedure during their treatment\n* patient whose parents have signed the informed consent\n* patient affiliated with social security or equivalent\n\nExclusion Criteria:\n\n* patient with visual or hearing impairement\n* patient with epilepsy or other neurological disease\n* patient with psychiatric disease'}, 'identificationModule': {'nctId': 'NCT05592132', 'acronym': 'DOREVI', 'briefTitle': 'Use of Virtual Reality in Pain Management in Pediatric Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022/CHU/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients randomized in this arm will have the virtual reality headset associated to the standard care', 'interventionNames': ['Other: Virtual reality headset']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'patients randomized in this arm will have standard care.'}], 'interventions': [{'name': 'Virtual reality headset', 'type': 'OTHER', 'description': 'Each patient in this treatment group will use a virtual reality headset during 3 procedures. During each procedure, the pain level will be assessed and compared with the assessed group.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97400', 'city': 'Saint-Denis', 'status': 'RECRUITING', 'country': 'Reunion', 'contacts': [{'name': 'Yves REGUERRE, MD', 'role': 'CONTACT'}, {'name': 'Yves REGUERRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de La Réunion', 'geoPoint': {'lat': -20.88231, 'lon': 55.4504}}], 'centralContacts': [{'name': 'Yves REGUERRE', 'role': 'CONTACT', 'email': 'yves.reguerre@chu-reunion.fr', 'phone': '+262262905676'}, {'name': 'Emilie TECHER', 'role': 'CONTACT', 'email': 'emilie.techer@chu-reunion.fr', 'phone': '+262262906289'}], 'overallOfficials': [{'name': 'Yves REGUERRE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de La Réunion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}