Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety Level
研究概览
简要总结
The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
- Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer?
- Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium.
Participants will:
- Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher
- Have preoperative anxiety assessed at predefined time points
- Be evaluated for postoperative emergence delirium during recovery
详细描述
This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2).
The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- •Ability to communicate verbally
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders
- •Chronic pain conditions or ongoing medical treatments that may affect anxiety levels
- •Refusal to participate despite repeated encouragement by the investigators
- •Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol
- •Previous history of surgical procedures
研究组 & 干预措施
Toy Car Transfer
Participants will be transferred to the operating room using a ride-on toy car.
干预措施: Toy car (Other)
Standard Stretcher Transfer
Participants will be transferred to the operating room using a standard hospital stretcher
干预措施: Standard Transfer (Other)
结局指标
主要结局
Preoperative Anxiety Level
时间窗: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
次要结局
- Postoperative Emergence Delirium(From extubation through 30 minutes after admission to the post-anesthesia care unit)
研究者
Filiz Kaya
M.D.
Ankara City Hospital Bilkent