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临床试验/CTRI/2026/03/105952
CTRI/2026/03/105952尚未招募不适用

Effectiveness of Eye Closing on Clinical Anxiety During Non-Sedated Upper Gastrointestinal Endoscopy: A Randomized Controlled Single Centre Study In Eastern India

Dr Sanjib Kumar Kar1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
142
试验地点
1

研究概览

简要总结

Upper gastrointestinal endoscopy (UGIE) is an effective and reliable procedure that is widely used

for the diagnosis and treatment of gastrointestinal disorders. However, UGIE is a difficult, stressful, anxiety-associated, and unpleasant diagnostic and therapeutic method.

This situation destroys the communication between the patient and the endoscopy team, decreases the comfort of the patient, and prevents an optimal performance by the endoscopist.

Patients experience anxiety prior to surgical and gastrointestinal procedures due to the fear of pain and/or to the negative past experiences of those around them. Anxiety is defined as an emotional state of fear, tension, panic, or anticipation of an unpleasant experience.

Recent literature highlights the multifaceted nature of preoperative anxiety, identifying factors such as fear of diagnosis, procedural pain, and the general unknown as critical contributors to increased patient distress. The BAI is designed to assess the physical manifestations of anxiety. The Beck Anxiety Inventory (BAI), a reliable self-reporting tool, has been extensively used to quantify levels of anxiety, offering clinicians a practical means to assess and address this critical aspect of patient care .The BAI is less concerned with the cognitive dimensions of anxiety and is therefore more suitable for patients presenting with physical symptoms.

 Pain-related anxiety is one of the main concerns for EGD patients. Although endoscopic procedures are generally not painful, patients may still experience anxiety about potential sensations during upper gastrointestinal endoscopy.

Visual stimuli are known to arouse physiologic indicators of anxiety.Coverage of patients’ eyes with surgical pads may eliminate these stimuli. So reduction of anxiety can be achieved by closing of eye during procedure. However The exact mechanism of this is yet to be understood.

 Anxiety before and after the procedure adversely affects patients compliance with treatment and quality of life. In several studies, various methods, including informing patients and playing music before the procedure, have been attempted to reduce anxiety in patients.

Despite the recognised impact of anxiety on patient outcomes, there exists a gap in the literature regarding the comparative analysis of anxiety levels between patients undergoing UGIE with close eye vs open eye during procedure.

While sedation can be used to improve patient comfort, unsedated endoscopy remains a viable alternative due to its cost-effectiveness and lower risk of complications. However, performing endoscopy without sedation can significantly exacerbate anxiety in many patients, affecting their experience of the procedure and their co-operation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Consecutive adult (Morethan 18 years age) patients undergoing Non sedated upper GI endoscopy in our hospital will be included in the study.

排除标准

  • Inability to communicate, very sick patient, Patient undergoing Sedation during UGIE Study.

研究者

发起方
Dr Sanjib Kumar Kar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanjib Kumar Kar

Indian Institute of Gastroenterology and Hepatology

研究点 (1)

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