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

Autism Clinical Trial

— YODA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577234
• Other study ID #: APHP220662
• Secondary ID: 2022-A00871-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Violaine SMAIL-FAUGERON, MD
• Phone: 01 53 11 14 15
• Email: violaine.smail-faugeron[@]u-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism

Intervention

Other:
• 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.

Behavioral:
• 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).

Locations

Country	Name	City	State
France	Hôpital Bretonneau - Service d'odontologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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