Comparison of Anxiety During Mask Induction of Anesthesia in Pediatric Patients With an Immersive/Interactive Technological Intervention Versus Traditional Care: A Latin American Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pediatric anxiety
研究概览
简要总结
This study is designed to evaluate the effect of technology as a distraction technique during anesthetic induction in children, starting from their arrival to the operating room. An interactive film will be displayed using a projector (BERT: Bedside Entertaining and Relaxation Tool) mounted on a whiteboard in front of the child's gurney. The primary outcome is perioperative anxiety, measured with the Modified Yale Preoperative Anxiety Scale (mYPAS).
详细描述
This study is a randomized, controlled, open-label, parallel-assignment clinical trial designed to evaluate the effect of a non-pharmacologic technological intervention (projected video game) on perioperative anxiety in children during anesthetic induction.
Study type: Prospective, comparative clinical trial. Randomization: Simple randomization in a 1:1 ratio using an electronic sequence generated and administered in REDCap®.
Masking: Open-label (no blinding), as healthcare staff, caregivers, and patients can identify the presence or absence of the projected video game during induction. However, statistical analyses will be performed by investigators who did not take part in the intervention's implementation, in order to minimize bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants, caregivers, and clinical staff (anesthesia/OR teams) are not masked. Outcome assessors who score mYPAS, HRAD+/-, and ICC from video recordings are masked to group assignment: recordings are framed to exclude any view of the projection/screen and audio cues are removed; raters receive only a study ID and time point. The data team/statistical analysts remain masked until the analysis plan is finalized and the database is locked. The allocation sequence is concealed within REDCap and is revealed to implementers only at the time of induction. Unmasking of raters or analysts will occur only for prespecified safety reviews or after database lock. Inter-rater agreement (intraclass correlation) will be monitored to ensure the quality of masked assessments.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing elective procedures under general anesthesia at Clinica Alemana
- •Parent or caregiver presence for mask induction
- •ASA I, II
- •Ages 2-6 years of age
- •Spanish speaking
- •Parental consent/patient assent
排除标准
- •Patient or parental does not consent
- •ASA ≥ III
- •Emergency surgery
- •Intravenous induction of anesthesia
- •Patient with a significant neurological condition or major developmental disability
- •Severe visual or auditory defects
- •Patients admitted using a crib as the mode of transport
结局指标
主要结局
Pediatric anxiety
时间窗: Perioperative/anesthetic induction
Pediatric anxiety levels during mask induction as measured through the Modified Yale Preoperative Anxiety Scale (mYPAS). The Modified Yale Preoperative Anxiety Scale (mYPAS) is a 22-item checklist divided into five categories: "activity," "vocalization," "emotional expressiveness," "apparent arousal," and "relationship with parents." Each category consists of a list of interrelated behaviors, the most representative of which is the score for that category. The mYPAS score ranges from 23.3 to 100; the threshold for considering patients with anxiety is \> 30.
次要结局
- Affect and Cooperation(Perioperative/anesthetic induction)
- Compliance(Perioperative/anesthetic induction)
- Caregiver Satisfaction With the Induction Experience(Perioperative/after anesthetic induction)
- Long-term behavioral outcomes(2 weeks after surgery)
- Correlation to HRAD+/- to mYPAS(Single time point at mask application during anesthetic induction (Day 0, intraoperative))
- Correlation to HRAD+/- to ICC(Single time point at mask application during anesthetic induction (Day 0, intraoperative).)