Hôpital Bretonneau - Service d'odontologie
Paris, France
NCT Number: NCT05577234
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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Notify Me6 year–17 year
All sexes
Interventional
Not applicable
Paris, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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
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
Time frame: at the end of each follow-up visit, on average 3 months
Use of MEOPA: administration of MEOPA during the session
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
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.
Assistance Publique - Hôpitaux de Paris
Other
Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients
Acronym: YODA
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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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