Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Management of Preoperative Anxiety and Sedation in Pediatric Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Modified Yale Preoperative Anxiety Scale (mYPAS) scores
研究概览
简要总结
This observational study aims to compare the effects of short video viewing and intranasal dexmedetomidine administration-both of which are part of routine clinical practices in the pediatric endoscopy unit-on preoperative anxiety levels and the need for intravenous sedation. Patients who are exposed to these interventions as part of routine clinical care will be included in the study.
详细描述
Pediatric patients scheduled for upper or lower gastrointestinal endoscopy in the hospital's endoscopy unit and who receive either short video viewing or intranasal dexmedetomidine as part of standard clinical practice will be included in this study. The primary objective is to compare these two modalities in terms of preoperative anxiety, requirement for sedative agents, difficulty of intravenous access, and levels of satisfaction reported by parents and endoscopists.
This study will be conducted with a prospective and observational design. Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:
T1: Upon arrival in the preoperative holding area, T2: Prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction. The consumption of sedative agents (e.g., propofol) will be recorded in terms of total dosage (mg) and dosage per kilogram of body weight (mg/kg). The difficulty of intravenous access will be rated on a 5-point scale. Parental satisfaction will be assessed using the PedsQL Healthcare Satisfaction Scale, while endoscopist satisfaction will be evaluated using a 5-point Likert scale. Statistical analyses will be performed to compare the outcomes between the two study groups.
Short Video Viewing Group:
All patients will be brought to the preoperative preparation area. Anxiety assessments using the mYPAS will be conducted at the designated time points. Patients will be allowed to watch short videos (such as YouTube Shorts, TikTok, Instagram Shorts, or cartoons), selected based on their preferences and filtered for age-appropriateness. Patients who refuse to watch the videos or encounter technical difficulties will be excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 2-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II
排除标准
- •Patients under 2, over 12, or with ASA score >2
- •Cardiovascular diseases
- •Refuse to participate
结局指标
主要结局
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
时间窗: 1hour
Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points: T1: upon arrival in the preoperative holding area, T2: prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction.
次要结局
- Recovery Time(1 hour)
- Sedation Scores(2 hour)
- The difficulty level of intravenous (IV) access(1 hour)
- Endoscopist satisfaction(2 hour)
研究者
caner genc
Associate professor (Anesthesiology Specialist)
Samsun University
