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临床试验/NCT05399199
NCT05399199已完成不适用

The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2022年6月5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
93
试验地点
1
主要终点
change in patients pain scores

研究概览

简要总结

The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures

详细描述

Patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly caused by needle insertion into a fistula. Pain control is one of the main nursing tasks. Pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. The use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. As such, the use of virtual reality during painful procedures may serve as a distraction.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who are under- going conventional hemodialysis three times a week
  • •hemodialysis period of one month or more
  • •having a healthy AVF access with good function
  • •welling to participate in study

排除标准

  • •patients who have psychiatric diseases
  • •panic disorder, anxiety disorder
  • •dysfunctional fistula
  • •vertigo, issues with sight, hearing, or perception
  • •or use painkillers within three hours before hemodialysis

研究组 & 干预措施

study group

Experimental

干预措施: virtual reality distraction (Procedure)

control group

No Intervention

结局指标

主要结局

change in patients pain scores

时间窗: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

visual analogue scale which consists of a vertical line 100 mm long, one end of the line reads "No pain" and at the other is "Unbearable pain

change in patients anxiety scores

时间窗: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

STAI includes two subscales with 20 items each that assess state and trait anxiety .The State Anxiety Scale requires individuals to describe their feelings at a specific moment under specific circumstances, while the Trait Anxiety Scale requires them to describe the way they feel in general.

次要结局

  • change in patients satisfaction score(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))
  • change in patients heart rate(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))
  • change in patients respiratory rate(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))
  • change in patients systolic blood pressure(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))
  • change in patients diastolic blood pressure(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))
  • change in patients Oxygen saturation (SpO2)(will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction))

研究者

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

mohamed elsayed hamed elzeky

lecturer, medical surgical nursing department, faculty of nursing, Mansoura university

Mansoura University

研究点 (1)

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