Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Yale Preoperative Anxiety Scale (mYPAS )
研究概览
简要总结
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
详细描述
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
Patients admitted for an alveolar bone graft with an iliac donor site as part of the treatment of their cleft lip and palate will be include for two reasons:
- It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
- It is a population with long individual medical histories and, potentially, subjected to significant surgery-related stress.
Patients will be randomized into two groups: with LUNII and without LUNII.
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 6 years.
- •Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate
- •Primary alveolar bone graft or first side when bilateral cleft
- •Followed at Necker since birth and operated according to the protocol used in the department.
- •Consent signed by the holder (or holders) of parental authority
排除标准
- •Medical care different from the usual protocol applied in the service (secondary surgery, age > 7 years)
- •Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft
- •Possession and/or prior use of LUNII by the child
结局指标
主要结局
Yale Preoperative Anxiety Scale (mYPAS )
时间窗: At the time of anesthetic induction
Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety)
Number of hours spent with the interactive story teller LUNII before surgery
时间窗: Day of surgery (D0)
Number of hours spent with the interactive story teller LUNII
次要结局
- Analgesic administration(Up to 1 week)
- Visual Analogue pain Scale (EVA)(Up to 1 week)
- Duration between the operation and the first survey(Up to 1 week)
- Length of hospitalization(Up to 1 week)