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临床试验/NCT06159829
NCT06159829已完成不适用

Determination of the Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy: A Randomized Controlled Trial

Çankırı Karatekin University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy

研究概览

简要总结

Background: Virtual reality (VR) is a tool that uses three-dimensional computer graphics-based technologies to make an individual feel as if they are physically in the virtual environment by misleading their senses. In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping VR can be used to relieve acute pain and anxiety in hospitalized patients and was shown in several studies to reduce pain and anxiety levels Aim: to evaluate the effect of virtual reality on anxiety and pain in patients who underwent upper endoscopy without sedation.

Design: A single-centre, parallel-group, randomised control trial. Methods: The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution. During the upper endoscopy procedure, patients in the intervention group watched a video of natural scenery through virtual reality goggles. The study outcomes were anxiety and pain.

详细描述

Gastrointestinal (GI) diseases are an important public health problem in Turkey and worldwide.The prevalence of upper GI diseases in Turkey is reported to be 32.7%. A large-scale global study suggested that more than 40% of people have GI disease that affects quality of life and use of health services.

Although upper GI tract endoscopy is an important interventional procedure used in the diagnosis of diseases, it causes patients discomfort and anxiety. Different studies have indicated that 5.5%-48.3% of individuals undergoing upper GI tract endoscopy experience severe anxiety, 15.6%-51.6% experience moderate anxiety, and 78.9% experience mild anxiety. In addition, symptoms such as gagging, nausea, abdominal bloating, and pain can be seen during the endoscopy procedure. Anxiety and pain may affect a patient's compliance and tolerance of the procedure, resulting in the procedure being unnecessarily prolonged and potentially increasing the incidence of complications.

Intravenous sedative and analgesic agents are frequently used during endoscopic procedures. However, sedative agents may cause complications such as phlebitis, hypoxemia, airway obstruction, hypoventilation, hypotension, arrhythmia, and aspiration. Especially in short procedures such as upper GI tract endoscopy, sedation-free endoscopy was introduced both to prevent adverse effects and reduce costs. In addition, some patients do not want to receive sedation due to concerns such as loss of control, allergies, cardiac arrest, and inability to wake up. In such cases, non-pharmacological interventions can be used to increase the patient's comfort, compliance with the procedure, and tolerance in sedation-free upper endoscopies. One of these interventions is Virtual reality (VR). In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping.

The aim of our study was to evaluate the effect of VR on anxiety and pain in patients undergoing upper endoscopy without sedation. This study will help fill the literature gap and guide future research.

METHODS Trial design, participants and setting A single-centre, randomised controlled study was conducted in accordance with the CONSORT guideline. The population of the study comprised patients presenting to a city hospital in the Central Anatolia region of Turkey between June 22 and December 30, 2022 for upper endoscopy without anesthesia. The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Not using analgesics before the procedure,
  • Not using anticoagulants within the last 24 hours,
  • Having no vision or hearing problems
  • Not receiving sedation
  • Having no cognitive or psychiatric disorder that may affect understanding and communication

排除标准

  • 未提供

结局指标

主要结局

Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy

时间窗: Patients' pain levels were evaluated immediately after the procedure was completed.

Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between

次要结局

  • Comparison of mean anxiety scores of patients in the intervention and control groups of during endoscopy(Patients' anxiety levels were evaluated immediately after the procedure was completed.)

研究者

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

Figen EROL URSAVAŞ

Associate professor

Çankırı Karatekin University

研究点 (2)

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