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

NCT ID: NCT05577234

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-24
• Study Completion Date: 2024-03-25

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).

Conditions

Autism

Keywords

Animal-assisted therapy; child; autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Animal-assisted intervention

Intervention Type: 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.

Venham scale modified by Veerkamp

Intervention Type: 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).

Standard care

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

Group Type: OTHER

Venham scale modified by Veerkamp

Intervention Type: 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).

Interventions

Animal-assisted intervention

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.

Intervention Type: OTHER

Venham scale modified by Veerkamp

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc TRELUYER, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bretonneau - Service d'odontologie

Paris, , France

Countries

France

Other Identifiers

2022-A00871-42

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220662

Identifier Type: -

Identifier Source: org_study_id