Do Certified Therapy Dogs Improve Behavior and Reduce Anxiety in Children Who Receive Administration of a Local Anesthetic for Dental Procedures? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Behavioral measure, using the Frankl score
研究概览
简要总结
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.
The main questions it aims to answer are:
- Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
- How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
- Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?
All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
- •Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
- •Children whose parents/guardians are willing to consent to the child participating in the study
- •Availability of parent to be present during treatment
- •Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour
排除标准
- •Patients whose cases are considered emergencies
- •Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
- •If patient's medical status has worsened since initial evaluation
- •Known allergy to dogs or other animals
- •Past history of dental trauma
- •Past history of animal bites or traumatic experience with a dog
- •Emotional or developmental delays
- •If, on the day of the treatment, patient presents with fever or other illness
研究组 & 干预措施
Therapy Dog
This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure.
干预措施: Therapy Dog (Behavioral)
Control
The control group receives standard of care and does not have a therapy dog present in the room during their treatment.
结局指标
主要结局
Behavioral measure, using the Frankl score
时间窗: This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
次要结局
- Parent survey responses(The surveys will be administered immediately after the procedure.)
- Anxiety measure, oxygen saturation(Oxygen saturation will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure)
- Microbial concentration(Experimental group: prior to arrival of therapy dog, and after departure of therapy dog. Control group: prior to arrival of participant, after departure of participant)
- Anxiety measure, heart rate(The heart rate will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure)