Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT05577234
Status:
COMPLETED
Last Update Posted:
2024-12-30
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients (YODA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average anxiety', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Average anxiety of the child during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third treatment session (without animal assisted intervention). Score on a scale : Min = 0 Max = 5 : 0 = relaxed, 1 = uneasy, 2 = tense, 3 = unwilling, 4 = very troubled, 5 = totally out of touch'}], 'secondaryOutcomes': [{'measure': 'Evaluate the success of the care session (complete achievement of the planned objective)', 'timeFrame': 'at the end of each follow-up visit, on average 3 months', 'description': 'Overall success of the session: dental care completed in its entirety'}, {'measure': 'Validate the use of MEOPA administration', 'timeFrame': 'at the end of each follow-up visit, on average 3 months', 'description': 'Use of MEOPA: administration of MEOPA during the session'}, {'measure': "Assess the types of acts for which animal assisted intervention reduces the child's anxiety", 'timeFrame': 'at the end of each follow-up visit, on average 3 months', 'description': 'Types of procedures for which animal assisted intervention reduces anxiety: assessment of anxiety by the Venham scale modified by Verkamp measured at the end of each type of procedure : waiting room, entry into practice, X-rays, anaesthesia, placement of the dam, use of rotary instruments'}, {'measure': 'Assessing the safety of animal assisted intervention for oral care', 'timeFrame': 'at the end of each follow-up visit, on average 3 months', 'description': 'Occurrence of undesirable events associated with the animal assisted intervention, including infectious events of the zoonosis type (assessment by the practitioner at the beginning of each session and by the accompanying person who must report to the practitioner any manifestation that has appeared since the last session), episodes of agitation linked to the presence of the dog, bites.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Animal-assisted therapy', 'child', 'autism'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism.', 'detailedDescription': 'The particularity of some disabled patients, especially those with an autism spectrum disorder, is represented by anxiety, which can range from a slight tension to screaming or even extreme agitation. This behavior can make therapeutic management difficult, both for the patient and the caregiver. This is particularly true for oral health care, where the cooperation of the patient is essential. Conventional behavioral approaches, with implementation of a multitude of adaptive strategies, has a fundamental role to play. With disabled patients, these techniques are most often based on non-verbal or para-verbal communication rather than on linguistic procedures. In this context, an Animal Assisted Intervention could be of major help. The primary outcome is average child anxiety during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third session of care (without animal-assisted therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minors aged ≥ 6 to ≤ 17 years,\n* Carriers of Autism Spectrum Disorder.\n* Child with an average Venham scale score ≥ 3 at the end of the care of the inclusion session\n* Who accept the presence of the dog\n* Who declare having been in contact with a dog in the past\n* Consent from the child's legal guardians for the child's participation in the study,\n* Be affiliated to a social security scheme in their own name or be the legal guardian of a person with parental authority.\n* A state of health requiring a simple, non-complex dental procedure (preventive, carious, traumatic or orthodontic care, excluding complex surgery in the operating theatre)\n* A state of health requiring a dental treatment protocol consisting of at least 3 scheduled treatment sessions spaced at least 7 days and no more than 21 days apart.\n\nExclusion Criteria:\n\n* Child with dog allergy\n* Cynophobia\n* Who claims never to have been exposed to a dog (allergy risk not assessed)\n* Patient on AME"}, 'identificationModule': {'nctId': 'NCT05577234', 'acronym': 'YODA', 'briefTitle': 'Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients (YODA)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients', 'orgStudyIdInfo': {'id': 'APHP220662'}, 'secondaryIdInfos': [{'id': '2022-A00871-42', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Animal-assisted intervention', 'description': "The dog accompanied by the zootherapist will participate in the care of the sessions. During these sessions, the dog will be brought into the child's presence in the waiting room until the end of the dental consultation.", 'interventionNames': ['Other: Animal-assisted intervention', 'Behavioral: Venham scale modified by Veerkamp']}, {'type': 'OTHER', 'label': 'Standard care', 'description': 'The treatment sessions will only involve the use of conventional behavioural strategies.', 'interventionNames': ['Behavioral: Venham scale modified by Veerkamp']}], 'interventions': [{'name': 'Animal-assisted intervention', 'type': 'OTHER', 'description': 'The dog accompanied by the zootherapist will participate in the care of sessions 1 and 2. During these two sessions, the dog will be present with the child in the waiting room until the end of the dental consultation. Session 3 will take place without the dog being present.The usual management with conventional behavioural strategies and possible administration of MEOPA will be implemented during the 3 treatment sessions.', 'armGroupLabels': ['Animal-assisted intervention']}, {'name': 'Venham scale modified by Veerkamp', 'type': 'BEHAVIORAL', 'description': "The Venham scale modified by Veerkamp, based on observation of one's behaviour and used in current practice, ranges from 0 (relaxed) to 5 (totally disconnected from the reality of danger).", 'armGroupLabels': ['Animal-assisted intervention', 'Standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': "Hôpital Bretonneau - Service d'odontologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Marc TRELUYER, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}