Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Average anxiety
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Child with dog allergy
- •Cynophobia
- •Who claims never to have been exposed to a dog (allergy risk not assessed)
- •Patient on AME
研究组 & 干预措施
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.
干预措施: Animal-assisted intervention (Other)
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.
干预措施: Venham scale modified by Veerkamp (Behavioral)
Standard care
The treatment sessions will only involve the use of conventional behavioural strategies.
干预措施: Venham scale modified by Veerkamp (Behavioral)
结局指标
主要结局
Average anxiety
时间窗: 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
次要结局
- 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)
- 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)
- Validate the use of MEOPA administration(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)