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临床试验/NCT07177573
NCT07177573尚未招募不适用

The Effects of Virtual Reality on Pain, Anxiety, and Comfort During Continuous Passive Motion After Total Knee Arthroplasty

Celal Bayar University0 个研究点目标入组 102 人开始时间: 2025年9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
入组人数
102
主要终点
Pain, Anxiety, and Comfort Levels during Continuous Passive Motion

研究概览

简要总结

The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty

详细描述

The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty Study Hypotheses

H0: The use of virtual reality during continuous passive motion following total knee arthroplasty does not reduce pain levels.

H1: The use of virtual reality during continuous passive motion following total knee arthroplasty reduces pain levels.

H0: The use of virtual reality during continuous passive motion following total knee arthroplasty does not reduce anxiety levels.

H1: The use of virtual reality during continuous passive motion following total knee arthroplasty reduces anxiety levels.

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

入选标准

  • First-time total knee arthroplasty Postoperative day 2 Mobilized before CPM application Adequate vision and hearing to use the virtual reality device Oriented to person, place, and time No cognitive, sensory, or verbal communication impairments No history of vertigo No hypertension Not using sedative, anxiolytic, or similar medications Willing to voluntarily participate in the study

排除标准

  • Any diagnosed psychiatric disorder
  • History of vertigo
  • Hypertension
  • Using sedative, anxiolytic, or similar medications
  • Poor general condition
  • Unwillingness to participate

结局指标

主要结局

Pain, Anxiety, and Comfort Levels during Continuous Passive Motion

时间窗: Immediately before and after each CPM session on postoperative day 2 and day 3

Pain and comfort levels will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain/comfort and 10 indicates worst pain/maximal comfort. Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The effects of virtual reality during CPM on pain, anxiety, and comfort will be compared between the VR and control groups.

Pain, Anxiety, and Comfort Levels during Continuous Passive Motion

时间窗: Immediately before and after each CPM session on postoperative day 2 and day 3

Pain and comfort levels will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain/comfort and 10 indicates worst pain/maximal comfort. Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The effects of virtual reality during CPM on pain, anxiety, and comfort will be compared between the VR and control groups.

次要结局

未报告次要终点

研究者

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

Emel Yılmaz

Professor

Manisa Celal Bayar University

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