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临床试验/NCT06127758
NCT06127758尚未招募不适用

The Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety in Patients Planned for Open Heart Surgery

Uskudar University0 个研究点目标入组 60 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Personal Information Form

研究概览

简要总结

Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research.

Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale.

Hypothesis of the Research:

H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery.

H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 18 years and over,
  • Those who will undergo open heart surgery,
  • Those who have not had cardiovascular surgery before,
  • No communication problems,
  • Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
  • Does not have a psychiatric disease such as anxiety disorder, panic attack, depression,
  • Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study.

排除标准

  • Being under the age of 18,
  • Not having open heart surgery,
  • Those who have previously undergone cardiovascular surgery,
  • Having communication problems,
  • Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
  • Having a psychiatric disease such as anxiety disorder, panic attack, depression,
  • Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study.

结局指标

主要结局

Personal Information Form

时间窗: for 1 day

The form prepared by the researchers contains a total of 8 questions containing the patients' introductory information.

surgical fear scale

时间窗: for 1 day

There are 8 questions in the scale. The scale is an 11-point Likert type scale with a score between 0 and 10. The scale included two subscales related to the source of fear, each consisting of 4 items. While items 1 to 4 on the scale measure the fear of the short-term consequences of surgery, items 5 to 8 measure the fear of the long-term consequences of surgery (0: not at all afraid, 10: very afraid). An increase in the score indicates an increase in fear.

state anxiety scale

时间窗: for 1 day

It consists of a total of 40 items and is scored from 1 to 4. Scale items are evaluated using the "Likert type" scaling method as "1 = not at all", "2 = a little", "3 = a lot", "4 = completely". A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety. In the validity and reliability study of the scale, the alpha value was found to be 0.91.

次要结局

未报告次要终点

研究者

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

sabriye gül

postgraduate student

Uskudar University

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