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临床试验/NCT07704008
NCT07704008已完成不适用

The Effect of Virtual Reality Glasses Applied to Hemodialysis Patients on Vital Signs and Anxiety Level

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Change in Systolic Blood Pressure

研究概览

简要总结

This randomized controlled experimental study was conducted to evaluate the effects of virtual reality glasses used during hemodialysis on patients' vital signs and anxiety levels. A total of 56 adult patients receiving hemodialysis at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital were randomly assigned to either an experimental group or a control group. Patients in the experimental group watched a 4K virtual reality nature video with relaxing background music during hemodialysis, while the control group received standard hemodialysis care. Vital signs, pain, anxiety, and satisfaction were assessed to evaluate the effectiveness of the virtual reality intervention.

详细描述

The research was designed and conducted as a randomized controlled experimental study to determine the effects of virtual reality glasses on the vital signs and anxiety levels of hemodialysis patients.

The study population consisted of patients diagnosed with kidney failure who received hemodialysis at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2023 and May 2024. A total of 56 patients who volunteered to participate and met the inclusion criteria were included in the study. These patients were randomly assigned to two homogeneous groups according to gender and type of renal failure (acute/chronic): an experimental group (n=28) and a control group (n=28).

Patients in the experimental group watched a 4K virtual reality video featuring natural scenery accompanied by relaxing background music through virtual reality glasses during hemodialysis, whereas patients in the control group received standard hemodialysis care without any additional intervention.

Data were collected using the Patient Information Form, Vital Signs Follow-up Form, Visual Analog Scale for Pain (VAS), State Anxiety Scale, and Visual Analog Scale for Satisfaction (VAS-Satisfaction). Ethics committee approval, institutional permission, and written informed consent were obtained before the study was conducted.

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

  • Receiving hemodialysis treatment for the first time.
  • Age ≥18 years.
  • No visual, hearing, or cognitive impairment.
  • Able to communicate effectively.
  • Clinically stable.
  • No diagnosed psychiatric disorder or use of psychiatric medication.
  • No history of seizures.
  • Willing and able to provide informed consent.

排除标准

  • Previous hemodialysis treatment.
  • Age <18 years.
  • Visual, hearing, or cognitive impairment.
  • History of kidney transplantation.
  • Communication difficulties.
  • Diagnosed psychiatric disorder or use of psychiatric medication.
  • History of seizures.
  • Declined to participate in the study.

结局指标

主要结局

Change in Systolic Blood Pressure

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in systolic blood pressure measured before and after the hemodialysis session.

Change in Diastolic Blood Pressure

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in diastolic blood pressure measured before and after the hemodialysis session.

Change in Heart Rate

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in heart rate measured before and after the hemodialysis session.

Change in Respiratory Rate

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in respiratory rate measured before and after the hemodialysis session.

Change in Peripheral Oxygen Saturation (SpO₂)

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in peripheral oxygen saturation (SpO₂) measured before and after the hemodialysis session.

Change in Body Temperature

时间窗: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.

Change in body temperature measured before and after the hemodialysis session.

State Anxiety Level After Hemodialysis

时间窗: Immediately after completion of the hemodialysis session.

State anxiety measured using the State Anxiety Inventory (STAI-State), a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety. Assessment was performed immediately after completion of the hemodialysis session.

次要结局

  • Change in Pain Score(Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.)
  • Participant Satisfaction Score(Immediately after completion of the hemodialysis session.)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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