Impact of a Breath-controlled Video Game App on Preoperative Anxiety, Induction Behavior and Parent Experience: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Primary aim (induction distress)
研究概览
简要总结
The proposed research study will assess the impact of a newly developed, breath-controlled app and custom-designed tablet (equipped with a breathing sensor) on the patient and parent's preoperative anxiety and anesthesia induction experience.
详细描述
Aim 1: Determine whether induction distress differs between patients using the breathing-controlled app and those using standard care interventions: The investigators will measure patient compliance with induction using the Child Induction Behavioral Assessment (CIBA). The investigators predict that patients using the breathing-controlled app will demonstrate significantly better induction compliance. Older children (ages 6-8) are typically more cooperative with induction than younger children (ages 3-5 years). Both age groups will be studied to determine whether there are age-related differences impacting receptiveness to the app.
Aim 2: Compare patient anxiety between the breath-controlled app and control group. The investigators will measure child preoperative anxiety (modified Yale Preoperative Anxiety Scale, the "mYPAS-SF"). The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for children in the breath-controlled app group.
Aim 3: Compare parent anxiety between the breath-controlled app and control group. The investigators will measure parental anxiety using the Visual Analog Scale for Anxiety, the "VAS-A". The investigators predict there will be significantly lower anxiety (mYPAS-SF) during induction for parents in the breath-controlled app group.
Aim 4: Determine overall family satisfaction with the induction experience. A survey will be administered to assess satisfaction levels with induction behavioral interventions and determine whether these scores differ between the intervention and standard care group. The investigators predict that satisfaction scores will be higher in the intervention group than the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to Same Day Surgery department at CCHMC Liberty campus
- •Outpatient or 23 hour admission
- •Any surgery or procedure under anesthesia
- •Ages 3 to 8 years
- •Male or female
- •Any ethnicity
- •American Society of Anesthesiologists (ASA) physical classification status I or II
- •Patient has never had a prior anesthetic
- •Family and participant communicate primarily in English & signed English anesthesia consent
- •Normal neurocognitive development
- •Patient is undergoing inhalation induction using an anesthesia mask
- •Parent/guardian is present for induction
- •Patient does not receive a premedication for anxiety
排除标准
- •Neurocognitive delays
- •Developmental delays/Behavioral diagnoses, such as (but not limited to) ADHD, Autism, Oppositional defiant disorder, Obsessive Compulsive Disorder, Anxiety disorder
- •Patient takes medications routinely for behavioral issues
- •Tracheostomy
- •Inpatient or planned >23 hour admission
结局指标
主要结局
Primary aim (induction distress)
时间窗: During anesthesia induction
Induction distress (Child induction behavioral assessment tool, the "CIBA"), scored by reviewing behavioral descriptions of 3 categories, "Smooth, "Moderate", or "Difficult"
次要结局
- Secondary aim (anxiety)(Parental preoperative anxiety (in Same Day Surgery) and anxiety during anesthesia induction (measured immediately after induction))
- Secondary aim (satisfaction)(Immediatly after anesthesia induction)