Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06405620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation', 'timeFrame': '1 month', 'description': 'number of activations of the robot and duration of the activations'}], 'secondaryOutcomes': [{'measure': 'Psychological impact of the use of a social assistance robot on the child, his parents and his siblings', 'timeFrame': 'Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45', 'description': 'psychological effects measured by semi-directive interviews of the parents and the brothers and sisters'}, {'measure': 'Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service', 'timeFrame': 'Visit 2 between Day 21 and Day 45', 'description': 'The effects will be explored through semi-structured interviews of nursing professionnals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Isolation']}, 'descriptionModule': {'briefSummary': 'During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.\n* Children who have accepted the robot and whose parents have accepted its use in their home.\n* Agreement of holders of parental authority for the inclusion of the hospitalized child.\n\nExclusion Criteria:\n\n* Patient or two parents who do not have a sufficient level of French for research.\n* Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.\n* Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.'}, 'identificationModule': {'nctId': 'NCT06405620', 'acronym': 'BUDDY-GUARD', 'briefTitle': 'Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Mixed Observational Study Evaluating the Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation', 'orgStudyIdInfo': {'id': 'RC31/23/0168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot intervention', 'description': 'the child uses the assistance robot', 'interventionNames': ['Other: Assistance robot']}], 'interventions': [{'name': 'Assistance robot', 'type': 'OTHER', 'description': "the child controls the robot at his parent's home from his room", 'armGroupLabels': ['Robot intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nadege ALGANS', 'role': 'CONTACT', 'email': 'algans.n@chu-toulouse.fr', 'phone': '0561777204'}], 'overallOfficials': [{'name': 'Rémi IZOULET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toulouse Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}