Preoperative Anxiety and Postoperative Recovery Delirium Observation in Children Who Underwent Gamified Breathing Exercise
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety Score
研究概览
简要总结
This study aims to evaluate the effect of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in children. The intervention includes games like ball blowing and bubble blowing. Anxiety is measured using the mYPAS-SF scale, and delirium is assessed with the PAED scale.
详细描述
This randomized controlled study investigates the impact of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in pediatric patients. Children in the intervention group and their parents receive specialized training on gamified breathing exercises starting 48-72 hours before surgery.
The intervention consists of various interactive breathing games selected based on the child's preference, including:
Ball Blowing: Blowing a cotton or ping-pong ball across a flat surface or into a 'goal' using a straw to encourage deep exhalation.
Bubble Blowing: Using soap bubbles to promote slow and controlled breathing patterns.
Tissue/Paper Blowing: Blowing on tissues to lift them or move paper windmills.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The primary and secondary outcomes (anxiety and delirium scores) are assessed by a blinded assistant researcher and a recovery room nurse who are unaware of the group assignments (intervention vs. control). This ensures that the evaluation of the Modified Yale Preoperative Anxiety Scale (mYPAS-SF) and the Pediatric Anesthesia Emergence Delirium (PAED) scale is conducted without bias.
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 to 7 years (preschool age).
- •Scheduled for elective (planned) surgery at Bursa Uludag University Hospital.
- •Physical status classified as ASA I or ASA II.
- •Children and parents who volunteer to participate and provide written informed consent.
排除标准
- •Children with chronic neurological or psychiatric disorders.
- •Children with existing respiratory system diseases that prevent breathing exercises.
- •Children or parents with communication barriers (e.g., severe hearing or speech impairment).
- •Children undergoing emergency (non-elective) surgery.
研究组 & 干预措施
Gamified Breathing Exercise Group
Participants in this group receive preoperative training on gamified breathing exercises. The intervention includes various interactive breathing games such as ball blowing, bubble blowing, candle blowing, or using breathing apps. Children are asked to perform these exercises for 10 minutes every hour, approximately 10-15 times per day, from 48-72 hours before surgery until the day of the operation.
干预措施: Gamified Breathing Exercises (Behavioral)
No Intervention
his group receives routine preoperative information and standard care only. No gamified breathing exercises are practiced by the participants in this group.
结局指标
主要结局
Preoperative Anxiety Score
时间窗: Immediately before the surgery (preoperative holding area).
This will be assessed using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). The scale evaluates five categories of behavior: activity, vocalization, emotional expressivity, state of arousal, and use of parents. Scores range from 22.92 to 100, where higher scores indicate higher levels of anxiety.
次要结局
- Postoperative Emergence Delirium Level(At 0, 15, and 30 minutes after arrival in the Post-Anesthesia Care Unit (PACU).)
研究者
Gulay Oztas
Research Assistant, PhD Student
Bozok University