Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Behavior (Face, Legs, Activity, Cry, and Consolability scale)
研究概览
简要总结
Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.
详细描述
Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.
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
- 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
- 是
入选标准
- •Age range: children aged 4- to 12-years
- •Health status: healthy children without significant medical conditions (ASA I or ASA II)
- •Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
- •Consent: written informed consent from the parent or legal guardian
- •Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years
排除标准
- •Allergies: children with known allergies to dogs or animal dander
- •Children with a fear or phobia of dogs
- •Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
- •Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
- •Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
- •Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
- •Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)
研究组 & 干预措施
Control
Standard-of-care basic behavior guidance during local anesthesia
干预措施: Standard-of-care basic behavior guidance (Behavioral)
Therapy dog presence
Therapy dog present during local anesthesia administration
干预措施: Therapy dog presence (Behavioral)
结局指标
主要结局
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
时间窗: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, with each category scored from 0 to 2. The higher the total score, which ranges from 0 to 10, indicates more distress.
次要结局
- Heart rate(Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia)
- Parent questionnaire(Following injection of local anesthetic)
- Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)(Upon entering the operatory and after administration of local anesthesia)
- Heart rate(Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia)
- Parent questionnaire(Following injection of local anesthetic)
研究者
James R. Boynton
Clinical Professor of Dentistry, Department of Pediatric Dentistry, School of Dentistry
University of Michigan