Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The children's anxiety will be measured using the State-Trait Anxiety Inventory (STAI) score (in children older than 12) or State-Trait Anxiety Inventory for children (STAIC) scores (in children from 8 to 12 years old)
研究概览
简要总结
Though much attention has been given to the practice of parental presence during invasive procedures in children in the ED, few studies have examined the patient's perspective. The only study to have addressed this issue used a single visual analog scale, which is not a well validated tool to assess children's distress level. Furthermore, no studies have assessed parental presence during fracture reduction; only a few incidental cases were reported in the literature. Finally, most studies evaluating parental presence had methodological limitations because of the absence of a control group.
The investigators seek to assess whether parental presence during fracture reduction under sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and children.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patients:
- •Patients aged 8 to 18 years old.
- •Patients requiring fracture reduction under conscious sedation by emergency department attending physician.
- •Patients able to understand basic spoken English or French.
- •Inclusion criteria for parents:
- •Parents able to understand basic spoken English or French.
排除标准
- •for patients:
- •Patients with moderate to severe mental retardation
- •Patients with altered mental status or intoxication
- •Patients with hemodynamic instability or several traumatic injuries (other than fractures) - these patients require several treatments and may not have time to complete our study.
- •Exclusion criteria for parents:
- •Parents presenting unacceptable behaviors for family presence
- •Uncooperative
- •Physically aggressive, combative
- •Threatening and argumentative
- •Unstable emotionally or cannot be calmed
- •Intoxicated or altered mental status
- •Suspicion of child abuse
- •Suspected perpetrator of violent crime
- •Parents with moderate to severe mental retardation.
- •Pregnant parent
结局指标
主要结局
The children's anxiety will be measured using the State-Trait Anxiety Inventory (STAI) score (in children older than 12) or State-Trait Anxiety Inventory for children (STAIC) scores (in children from 8 to 12 years old)
时间窗: at discharge (2 hours post randomisation)
The parents' anxiety will be measured using the STAI scores.
时间窗: At discharge (approximately 2 hours post randomisation)
次要结局
- Procedure time(1 hours)
- Doses and types of medications used(1 hour)
- Fracture reduction success and failure rates(1 hour)
- Attempt of reduction by the residents(1 hour)
- STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups(1 hour)
- Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale(1 hour)
研究者
Jocelyn Gravel
MD, MSc
St. Justine's Hospital