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临床试验/NCT06920121
NCT06920121已完成不适用

Effects of Virtual Reality Glasses and Stress Ball on Distress and Pain During Arteriovenous Fistula Cannulation

Istanbul Sabahattin Zaim University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年8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
发起方
入组人数
77
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Effects of Virtual Reality Glasses and Stress Ball on Distress and Pain During Arteriovenous Fistula Cannulation. The research was conducted as a randomized experimental study with a pre-test - post-test control group.

详细描述

Beginning 1-2 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

A stress ball will be applied to the patient 1-2 minutes before the start of the 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
Single (Participant)

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

  • •Be over 18 years old,
  • •Be able to speak and understand Turkish,
  • •Have the cognitive ability to answer the data collection tools,
  • •Be willing to participate in the study,
  • •Participate in a hemodialysis program three days a week,

排除标准

  • •Having a communication problem (hearing, language, understanding, etc.),
  • •Having a psychiatric diagnosis (To be checked from medical records),
  • •Having failed AVF cannulation at the first attempt,
  • •Having any signs of infection such as redness, swelling, open wound in the area where the procedure will be performed,
  • •Having used a sedative within the last 8 hours,
  • •Having used any painkillers before the procedure on the same day,

研究组 & 干预措施

Virtual reality glasses

Experimental

Virtual reality glasses Beginning 2-3 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product.

干预措施: Virtual reality glasses (Other)

Stress ball

Experimental

Before AVF cannulation, patients will be given a round, colored, medium-hard, high-quality silicone squeezable ball (the arm without vascular access will be used). In order to avoid implying that the procedure is inherently stressful, patients will be given the name squeeze ball when they are given information about the stress ball application. Patients will be instructed to continue squeezing and relaxing the stress ball (squeezing and relaxing once, counting from one to three) for 5 minutes before and throughout the AVF cannulation procedure. Patients will be instructed to focus their attention on the stress ball and focus on squeezing the stress ball.

干预措施: Stress ball (Other)

Control grups

No Intervention

Routine maintenance will be applied

结局指标

主要结局

Visual Analog Scale

时间窗: Immediately after the intervention (After AVF cannulation procedure)

The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

The Distress Thermometer (DT

时间窗: Immediately after the intervention (After AVF cannulation procedure)

The Distress Thermometer is a scale developed by Roth et al. (1998) for determining psychological distress in cancer patients. The thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (excessive stress). In a short and easy-tounderstand scale, patients can easily mark their distress levels in ranges indicated on the thermometer. The Turkish validity-reliability study of the Distress Thermometer for cancer patients was performed by Özalp et al. and the recommended cut-off score for the thermometer in this study was set at four and above.

Visual Analog Scale

时间窗: Baseline, pre-intervention (Before AVF cannulation procedure)

The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

The Distress Thermometer (DT

时间窗: Baseline, pre-intervention (Before AVF cannulation procedure)

The Distress Thermometer is a scale developed by Roth et al. (1998) for determining psychological distress in cancer patients. The thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (excessive stress). In a short and easy-tounderstand scale, patients can easily mark their distress levels in ranges indicated on the thermometer. The Turkish validity-reliability study of the Distress Thermometer for cancer patients was performed by Özalp et al. and the recommended cut-off score for the thermometer in this study was set at four and above.

次要结局

未报告次要终点

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

Zülfünaz ÖZER

Principal Investigator

Istanbul Sabahattin Zaim University

研究点 (1)

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