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临床试验/NCT07077200
NCT07077200已完成不适用

Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Management of Preoperative Anxiety and Sedation in Pediatric Endoscopy

Samsun University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月1日最近更新:
适应症

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

发起方
Samsun University
申办方类型
Other
责任方
Principal Investigator
主要研究者

caner genc

Associate professor (Anesthesiology Specialist)

Samsun University

研究点 (1)

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