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临床试验/NCT06718504
NCT06718504已完成不适用

The Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Upper Gastrointestinal System Endoscopy: Randomized Controlled Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change on pain intensity as measured by Visual Analog Scale

研究概览

简要总结

Upper gastrointestinal endoscopy is an invasive procedure used to diagnose and treat pathologies in the gastrointestinal mucosa. Since it is an invasive procedure, it can cause anxiety in patients before and pain during the procedure. Virtual reality glasses are an effective method used to reduce the pain and anxiety levels of patients during painful procedures. This study aimed to evaluate the effects of virtual reality glasses on pain, anxiety, and comfort in patients undergoing upper gastrointestinal endoscopy without sedation.

详细描述

This single-center randomized controlled parallel group study was conducted with 60 patients who underwent upper gastrointestinal endoscopy at the Endoscopy Unit of a training and research hospital in Istanbul. Patients in the virtual reality glasses group (n=30) watched videos of their preferred relaxing nature settings or videos without any violent content during the procedure. Patients in the control group (n=30) received no intervention. Data were collected using the Patient Information Form, Visual Analog Scale (for pain and comfort) and State Anxiety Inventory. Pain, comfort and anxiety levels of patients were assessed five minutes before and five minutes after the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •To have an upper gastrointestinal endoscopy for the first time
  • •To be performed an upper GI endoscopy without sedation
  • •To be between the ages of 18-75
  • •To be willing to participate in research

排除标准

  • •To use analgesic or anesthetic drugs before or during the procedure
  • •To use antidepressants, anxiolytic and sedative drugs
  • •To have communication difficulties and mental disability

研究组 & 干预措施

Intervention Group

Active Comparator

During the procedure, patients in the intervention group watched videos of their choice, either in a relaxing natural setting or without any violent content, using virtual reality glasses.

干预措施: Virtual Reality Glasses (Device)

Control Group

No Intervention

No intervention was applied to the patients in the control group.

结局指标

主要结局

Change on pain intensity as measured by Visual Analog Scale

时间窗: five minutes before endoscopy and five minutes after endoscopy

The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.

次要结局

  • Change on anxiety level as measured by State-Trait Anxiety Inventory(five minutes before endoscopy and five minutes after endoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Gezginci

Assoc. Prof.

Saglik Bilimleri Universitesi

研究点 (1)

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