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临床试验/NCT05807906
NCT05807906已完成不适用

The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients

Hacettepe University2 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2023年4月17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
入组人数
14
试验地点
2
主要终点
Pain-VAS Scale

研究概览

简要总结

The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.

Hypotheses of the Research:

H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.

H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.

In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

详细描述

  • Demographic/medical data will initially be recorded prior to fistula puncture.
  • The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
  • Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
  • The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
  • The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • No diagnosis of neuropathic pain
  • No sedatives, analgesics and sedatives are applied 3 hours before the application.
  • Not taking recently taken antipsychotic drugs and tranquilizers,
  • Deaf and visually impaired (to mark VAS pain)
  • Without cognitive and psychiatric diagnosis
  • Open to communication and cooperation
  • Patients who agreed to participate in the study

排除标准

  • Kidney transplant
  • Discomfort due to virtual reality glasses
  • Suspected/diagnosed COVID-19
  • Patients who want to leave the study voluntarily
  • Multiple fistula puncture attempts

研究组 & 干预措施

Intervention Group

Experimental

virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

干预措施: virtual reality application (Other)

Control Group

No Intervention

Routine nursing care and diet compliance narration

结局指标

主要结局

Pain-VAS Scale

时间窗: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth week.

VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.

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

Neşe Altinok Ersoy

Principal Investigator

Hacettepe University

研究点 (2)

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