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临床试验/NCT07448714
NCT07448714已完成不适用

Animal Assisted Therapy as a Behavioral Management Technique During Dental Treatment in Pediatric Patients

University of Puerto Rico1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Frankl Scale

研究概览

简要总结

The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old.

The main question it aims to answer is:

• Pediatric patients with poor behavior will improve their behavior in the presence of a therapy dog during dental treatments.

Researchers will compare patient behavior with and without the therapy dog to see if behavior during dental treatment improves with dog presence

Participants will complete two dental visits:

  1. First visit: without the therapy dog
  2. Second visit: with the therapy dog present In both visits, the child will receive the same dental treatment required in their treatment plan.

A faculty member will evaluate the child's behavior with and without the therapy dog. Parents or guardians will be asked to complete a sociodemographic questionnaire and a perception survey regarding dental treatment with or without the therapy dog.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients with ages between 4-12 years old
  • Patients who presents history of uncooperativeness during dental treatments and fear/anxiety in the dental setting, according to the parents.
  • Patients must have at least two quadrants of dental interventions of similar complexity available

排除标准

  • Children will be excluded if immunocompromised.
  • Children with a had a medical history of allergies and/or phobias to dogs.

研究组 & 干预措施

With a therapy dog

Experimental

The second dental treatment visit, in the presence of a therapy dog. The Frankel scale will be used by an external evaluator not the dental operator performing the dental treatment.

干预措施: animal assisted therapy (Other)

Without a therapy dog

No Intervention

The first dental treatment visit without the presence of a therapy dog, following general treatment procedure guidelines. The Frankel scale will be used by an external evaluator (not the dental operator) performing the dental treatment.

结局指标

主要结局

Frankl Scale

时间窗: through study completion, an average of 1 year

Frankl Scale 1. --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism. 2. -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn) 3. +) Positive. Acceptance of treatment, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively. 4. -) Definitely positive. Good rapport with the dentist, interest in the dental procedure, laughter and enjoyment. A Frankl behavior scale (FBR) scale will be recorded during the anesthetic procedure and during the operative/surgical procedure. Two dental visits of 1 hour each will be scheduled to perform dental treatments of similar complexity. One visit without a dog and a second visit with a therapy dog. The Frankl scale will be done by an external evaluator, not the dental operator performing the dental treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosana Hanke Herrero

Professor

University of Puerto Rico

研究点 (1)

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