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临床试验/NCT03324347
NCT03324347已完成不适用

Dog-Assisted Therapy in Dental Care Settings

University of Tromso2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Examination achieved; Yes or No

研究概览

简要总结

Dog-assisted therapy (DAT) is used in several contexts within various areas of health care. One documented effect is that the proximity of a dog may lower anxiety in perceived stressful situations. Many individuals are afraid to visit the dentist, and someone to the extent that they need medication or anesthesia in order to complete their dental treatment. Based on the literature and own empirical observations, the investigators believe that dog-assisted therapy in connection with dental care may have a positive effect on children with dental anxiety or children that avoid dental care. It is desirable to restrict the use of drugs for these patients because of associated risk and side effects.

The purpose of this pilot study is to evaluate whether using a specially trained therapy dog can have a positive effect on children who are afraid in a dental care setting. Eligible participants (n=16) will meet twice at the dental clinic; one treatment session with a therapy dog in the dental clinic and one without. The therapy dog will be accompanied by a certified dog handler. The investigators will measure physiological variations before, during and after the treatment session. The guardian will complete validated questionnaires portraying the participant's experience of previous dental care. The participant and their guardian will also complete validated questionnaires describing their reactions from the two treatment sessions. A descriptive log for each session will be completed by the investigators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are afraid of visiting the dental office / children who avoid dental treatment,
  • Children who accept the presence of a dog,
  • Parents or guardians who accept the presence of a dog

排除标准

  • Children or parent/guardian that are afraid of dogs,
  • Children or parent/guardian with known dog allergy,
  • Children who are immunocompromised,
  • Children who cannot understand or complete the patient-questionnaire

研究组 & 干预措施

Therapydog

Experimental

A certified therapydog (together with a certified dog-handler) will be present in the dental clinic while the child will undergo a clinical dental examination by licenced pediatric dentist.

干预措施: Therapydog (Procedure)

No therapydog

No Intervention

No therapydog will be present in the dental clinic while the child will undergo a clinical dental examination by licenced pediatric dentist.

结局指标

主要结局

Examination achieved; Yes or No

时间窗: up to 8 weeks

Whether the child complied or not, so that a clinical oral examination could be accomplished within 30 minutes

次要结局

  • Skin conductance (Electrodermal activity)(up to 8 weeks)
  • Heart rate variability(up to 8 weeks)
  • Child satisfaction(up to 8 weeks)
  • Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule)(up to 8 weeks)
  • Salivary cortisol level(up to 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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