Effectiveness of Preoperative Tour in Simulation Operating Theater in Reducing Preoperative Anxiety in Children and Their Parents: A Pragmatic, Single-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- children's preoperative anxiety at holding area.
研究概览
简要总结
this study conducted to evaluate the effectiveness of preoperative tour to simulation operating theater on reducing children's and parents' preoperative anxiety. half of the participant were taken in a tour to a simulation operating theater before the day of operation and the other half were given the standard of care.
详细描述
the investigators examined the effectiveness of a preoperative tour to a simulation operating theater guided by an expert anesthesia technologist on reducing the Preoperative anxiety levels for children who were scheduled for elective day case procedures under general anesthesia, and their parents' anxiety levels through a 10-months randomized controlled trial at tertiary medical center in Riyadh-Saudi Arabia, and confirmed that children and parents who received the intervention had significantly lower preoperative anxiety levels than controlled children and parents.
Given that, the results showed critical levels of preoperative anxiety among school age children, and that preoperative tour to simulation operating theater as a child-friendly maneuver is directly applicable and could be considered for children scheduled for day-case procedures under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
data collectors were unaware of participants groups.
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children who were scheduled for elective day-case procedures under general anesthesia at KFMC.
- •class 1 or 2 according to the American society of anesthesiology physical status.
排除标准
- •diagnosed as having mental or psychological disorders.
结局指标
主要结局
children's preoperative anxiety at holding area.
时间窗: at holding area before pushing patients inside operating theater.
measured using the modified-Yale Pre-Operative Anxiety Scale (m-YPAS). The m-YPAS is an observational anxiety scale used to assess anxiety levels in the preoperative period and during the induction of anesthesia. The total score of the scale ranged from 23 to 100, and the higher score means a worse outcome. The reference point to define high anxiety cases in the preoperative period is 30.
children's preoperative anxiety inside operating theater.
时间窗: immediately before anesthesia induction.
measured using the modified-Yale Pre-Operative Anxiety Scale (m-YPAS). The m-YPAS is an observational anxiety scale used to assess anxiety levels in the preoperative period and during the induction of anesthesia. The total score of the scale ranged from 23 to 100, and the higher score means a worse outcome. The reference point to define high anxiety cases in the preoperative period is 30.
parents' anxiety
时间窗: during the procedure.
a self-administered questionnaire, Parents' anxiety was assessed using a validated version of Beck Anxiety Inventory Scale (BAIS) into Arabic. The total scale score range from 0 to 63, where a score of 0-9 indicates no anxiety, 10-18 mild anxiety, 19-29 moderate anxiety, and 30-63 severe anxiety.
change from baseline in children's heart rate (HR) as a somatic response to anxiety
时间窗: two time-points, baseline measures of HR at holding area, and secondly inside the operating theater immediately before anesthesia induction.
somatic signs of anxiety, including children's heart rate (HR) were recorded.
change from baseline in children's systolic blood pressure (SBP) as a somatic response to anxiety
时间窗: two time-points, baseline measures of SBP at holding area, and secondly inside the operating theater immediately before anesthesia induction.
somatic signs of anxiety, including children's systolic blood pressure (SBP) were recorded.
parents' presence during anesthesia induction
时间窗: at the time of anesthesia induction during the study period.
the parents' attendance inside operating theater during anesthesia induction for their child, measured as (Yes or No).
次要结局
未报告次要终点
研究者
Hussein A. Battah
Principal Investigator
King Fahad Medical City