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临床试验/NCT07087990
NCT07087990已完成不适用

The Effect of Virtual Reality Glasses and Stress Ball on Anxiety, Pain, and Satisfaction in Patients Undergoing Coronary Angiography: A Randomized Controlled Study

Istanbul Sabahattin Zaim University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年3月1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
发起方
入组人数
105
试验地点
1
主要终点
Change in State Anxiety Inventory (SAI) Scores

研究概览

简要总结

This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.

详细描述

This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.

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
None

入排标准

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

入选标准

  • •Voluntary participation in the study
  • •Age 18 years or older
  • •Undergoing coronary angiography for the first time
  • •Cognitive ability to answer the questions
  • •No diagnosis of anxiety disorder and no use of medication for anxiety / no psychiatric diagnosis
  • •No physical disability preventing the use of the stress ball
  • •No problems with vision, hearing, or understanding

排除标准

  • 未提供

研究组 & 干预措施

VR Group"Participants in this group were provided with virtual reality glasses during coronary angio

Experimental

Participants in this group were provided with virtual reality glasses during coronary angiography to assess the effect on anxiety, pain, and satisfaction.

干预措施: Virtual Reality Glasses (Device)

Stress Ball Group

Experimental

Participants in this group used a stress ball during coronary angiography to evaluate its effect on anxiety, pain, and satisfaction.

干预措施: Stress Ball (Other)

Control Group

No Intervention

Participants in this group received standard care during coronary angiography without the use of virtual reality glasses or stress ball. Anxiety, pain, and satisfaction levels were assessed

结局指标

主要结局

Change in State Anxiety Inventory (SAI) Scores

时间窗: Before and immediately after coronary angiography procedure

the study will measure changes in situational anxiety levels of patients undergoing coronary angiography, using the State Anxiety Inventory (SAI) before and after the procedure with virtual reality glasses and stress balls. The SAI consists of 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80; higher scores indicate higher anxiety.

次要结局

  • Change in Anxiety Visual Analogue Scale (VAS) Scores(Before and immediately after coronary angiography procedure)
  • Change in Pain Visual Analogue Scale (VAS) Scores(Before and immediately after coronary angiography procedure)

研究者

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

Rabia Ozdemir

Principal Investigator

Istanbul Sabahattin Zaim University

研究点 (1)

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