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Completed

NCT Number: NCT05577234

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bretonneau - Service d'odontologie

Paris, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Average anxiety

    Time frame: 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 outcomes

  1. Evaluate the success of the care session (complete achievement of the planned objective)

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

    Overall success of the session: dental care completed in its entirety

  2. Validate the use of MEOPA administration

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

    Use of MEOPA: administration of MEOPA during the session

  3. Assess the types of acts for which animal assisted intervention reduces the child's anxiety

    Time frame: 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

  4. Assessing the safety of animal assisted intervention for oral care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: YODA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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