The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.
详细描述
The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing parental informed consents. Children were chosen according to the Faces version of Modified Child Dental Anxiety Scale scoring 26 or more.
The participants will be randomly allocated into 2 groups: Group I: Study group and Group II: Control group. The patients of group I (Study group) will undergo a session of biofeedback regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be managed by a routine behavioral management technique "Tell,show,do". Local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.
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
盲法说明
The operator will not be blinded to the treatment as the RESPeRATE™ will be used for the study group while the device will not be applied to the control group.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal healthy children (physical status ASA I & II).
- •Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf).
- •Dental procedure requiring local anesthesia.
- •Completion of a parental consent to participate in the study.
排除标准
- •Children on anxiolytic medication or using any medication directly related to emotional or cognitive function.
- •Children with special needs.
- •Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.
结局指标
主要结局
Heart Rate
时间窗: after 5 minutes
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Oxygen saturation
时间窗: after 5 minutes
Oxygen saturation will be monitored using an oximeter
Behavior Evaluation
时间窗: after 1 week during follow-up sessions
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Instructor of Dental Public Health and Statistician
University of Alexandria