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

NCT05577234 | Completed

• 2 other identifiers: APHP2206622022-A00871-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Animal-assisted therapy; child; autism

Outcome Measures

Primary Outcomes (1)

• Average anxiety

  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

  through study completion, an average of 3 months

Secondary Outcomes (4)

• 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

• Validate the use of MEOPA administration

  at the end of each follow-up visit, on average 3 months

• 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

• Assessing the safety of animal assisted intervention for oral care

  at the end of each follow-up visit, on average 3 months

Study Arms (2)

Animal-assisted intervention

EXPERIMENTAL

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.

Other: Animal-assisted intervention; Behavioral: Venham scale modified by Veerkamp

Standard care

OTHER

The treatment sessions will only involve the use of conventional behavioural strategies.

Behavioral: Venham scale modified by Veerkamp

Interventions

Animal-assisted intervention OTHER

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.

Animal-assisted intervention

Venham scale modified by Veerkamp BEHAVIORAL

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).

Animal-assisted intervention; Standard care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Minors aged ≥ 6 to ≤ 17 years,
• Carriers of Autism Spectrum Disorder.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Bretonneau - Service d'odontologie

Paris, France

Location

Related Publications (1)

• Hamdan S, Nguyen J, Abdoul H, Ollivier C, Treluyer JM, Courson F, Jungo S, Salmon B, Fron-Chabouis H, Smail-Faugeron V. Dog Therapy for Dental Care Among Autistic Children: A Randomized Trial. Pediatrics. 2026 Feb 1;157(2):e2025073469. doi: 10.1542/peds.2025-073469.

  PMID: 41506515 RESULT

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jean-Marc TRELUYER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: October 13, 2022
• Study Start: March 24, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)