Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients (YODA)

Not Applicable

Completed

• Conditions: Autism
• Interventions: Other: Animal-assisted intervention; Behavioral: Venham scale modified by Veerkamp

• Registration Number: NCT05577234
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2023-03-24
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Animal-assisted intervention	Animal-assisted intervention	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.
Animal-assisted intervention	Venham scale modified by Veerkamp	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.
Standard care	Venham scale modified by Veerkamp	The treatment sessions will only involve the use of conventional behavioural strategies.

Primary Outcome Measures

Name	Time	Method
Average anxiety	through study completion, an average of 3 months	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

Secondary Outcome Measures

Name	Time	Method
Assess the types of acts for which animal assisted intervention reduces the child's anxiety	at the end of each follow-up visit, on average 3 months	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
Validate the use of MEOPA administration	at the end of each follow-up visit, on average 3 months	Use of MEOPA: administration of MEOPA during the session
Evaluate the success of the care session (complete achievement of the planned objective)	at the end of each follow-up visit, on average 3 months	Overall success of the session: dental care completed in its entirety
Assessing the safety of animal assisted intervention for oral care	at the end of each follow-up visit, on average 3 months	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.

Trial Locations

Locations (1)

Hôpital Bretonneau - Service d'odontologie; 🇫🇷 Paris, France