Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Preoperative anxiety using m-YPAS-SF scoring tool
研究概览
简要总结
Children can experience high levels of anxiety immediately prior to surgery. In fact, this can be the most stressful part of the whole surgical experience for children. Anxiety before surgery is associated with problems after surgery; such as short-term increased need for pain medication and long-term sleep disturbances or behaviour change. Child Life, a program run in some North American children's hospitals has developed ways to reduce children's anxiety prior to surgery. These techniques can include role-play or story books amongst others.
In this study, the investigators aim to look at the benefits of the Child Life techniques on anxiety levels of children and their caregivers just prior to receiving anesthesia in the operating room. The study will include children between the ages of 3 and 10 years old, needing day case surgery lasting less than 2 hours, and having never had surgery before. They will be randomly allocated to either not receive any intervention by Child Life or to receive Child Life intervention in the period prior to their surgery, when they are waiting in the Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured as they arrive in the hospital and immediately prior to anesthesia, to see if there is a lower level of anxiety in the group receiving the Child Life intervention.
详细描述
RESEARCH DESIGN:
This is a prospective, randomized controlled clinical trial that will assess the effectiveness of immediate preoperative Child Life intervention in reducing preoperative anxiety prior to induction of anesthesia.
This prospective, randomized controlled clinical trial will compare two groups of children undergoing induction of anesthesia.
- Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the operating room (OR), the BC Children's Hospital (BCCH) 'parent hug' and standard distraction techniques
- Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practice techniques
The primary outcome measures will be the scores from validated observer ratings of anxiety at induction of anesthesia. A trained research assistant (RA) will observe and score the child's anxiety using the following validated tools:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective day surgery under general anesthesia, expected to last ≤ 2 hours
- •ASA I to III
- •Ages 3 - 10y
- •Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
排除标准
- •Previous surgery
- •Severe anxiety (according to the staff anesthesiologist) in the preoperative period, requiring sedative pre-medication
- •Severe anxiety in the preoperative period, deemed to require intervention by Child Life
- •Anticipated mask induction of anesthesia
研究组 & 干预措施
Group 1 (Standard Procedure)
Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the OR, the BCCH 'parent hug' and standard distraction techniques
Group 2 (Child Life)
Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practices
干预措施: Child Life (Behavioral)
结局指标
主要结局
Preoperative anxiety using m-YPAS-SF scoring tool
时间窗: 1 hour
Observational ratings of preoperative anxiety using m-YPAS-SFscoring tool
次要结局
- Preoperative anxiety using PACBIS scoring tool(10 min)
研究者
Zoe Brown
Principle Investigator
University of British Columbia