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临床试验/NCT04547322
NCT04547322已完成不适用

The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery

Mersin University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年6月1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
86
试验地点
2
主要终点
Change Anxiety Specific to Surgery Questionnaire score

研究概览

简要总结

The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.

详细描述

The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The researchers involved in the data analysis and statistics stages were blinded to the group assignment, too. However, those involved in the running of the study were not blinded. Also, the person who performed the measurements was not blinded due to the nature of VR application.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study included
  • conscious,
  • orientated and cooperated patients who could speak and understand Turkish,
  • who had no psychiatric diseases,
  • who were 18 years old and older,
  • who were scheduled for elective colorectal surgery for the first time,
  • who did not take any sedative drugs before surgery, and
  • who gave written and oral permission to participate in the study

排除标准

  • n The study excluded
  • had language problems,
  • underwent emergency surgery,
  • were over 65 years of age and
  • refused to participate in the study.

结局指标

主要结局

Change Anxiety Specific to Surgery Questionnaire score

时间窗: 10 minute

The psychological response of patients to preoperative anxiety was evaluated with Anxiety Specific to Surgery Questionnaire. With a total of 10 items, responses are made on a five-point Likert scale format ranging from 1 (do not agree at all) to 5 (completely agree). Anxiety Specific to Surgery Questionnaire score is obtained by adding the answers to all items (minimum score=10; maximum score=50). The increase in the scale score indicates that the level of anxiety increases. The researchers administered Anxiety Specific to Surgery Questionnaire to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement.

次要结局

  • Change systolic blood pressure(10 minute)
  • Change heart rate(10 minute)
  • Change diastolic blood pressure(10 minute)
  • Change respiratory rate(10 minute)
  • Change peripheral oxygen saturation(10 minute)

研究者

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

Gulay ALTUN UGRAS

Associate Professor

Mersin University

研究点 (2)

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