Clinical trial NCT05577234: Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients (YODA)
Official title: Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Animal-assisted therapy
child
autism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Minors aged ≥ 6 to ≤ 17 years,
* Carriers of Autism Spectrum Disorder.
* Child with an average Venham scale score ≥ 3 at the end of the care of the inclusion session
* Who accept the presence of the dog
* Who declare having been in contact with a dog in the past
* Consent from the child's legal guardians for the child's participation in the study,
* Be affiliated to a social security scheme in their own name or be the legal guardian of a person with parental authority.
* A state of health requiring a simple, non-complex dental procedure (preventive, carious, traumatic or orthodontic care, excluding complex surgery in the operating theatre)
* 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.

Exclusion Criteria:

* Child with dog allergy
* Cynophobia
* Who claims never to have been exposed to a dog (allergy risk not assessed)
* Patient on AME

Primary outcomes:
measure: Average anxiety
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
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
measure: Validate the use of MEOPA administration
timeFrame: at the end of each follow-up visit, on average 3 months
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
measure: Assessing the safety of animal assisted intervention for oral care
timeFrame: at the end of each follow-up visit, on average 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bretonneau - Service d'odontologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marc TRELUYER, MD, PhD
role: STUDY_DIRECTOR
References: