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临床试验/NCT06445387
NCT06445387已完成不适用

The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

Amasya University2 个研究点 分布在 2 个国家目标入组 108 人开始时间: 2021年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Pain Scores: Numerical rating scale

研究概览

简要总结

It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.

详细描述

After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).

Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.

Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.

Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.

The pain level of the patients was evaluated using a numerical rating scale;

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

It is a randomized controlled, single-blind, experimental study.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intervention in the femoral region,
  • Femoral sheath size is 6-7 fr,
  • Presence of only one sheath in the femoral region,
  • No analgesics were administered before femoral sheath removal,
  • Absence of serious bleeding and major hematoma in the femoral region,
  • Being over 18 years of age,
  • No communication problems,
  • Having a place and time orientation,
  • No dizziness,
  • Not having any psychiatric disease,
  • No visual, auditory or mental problems,
  • No previously identified cold allergy,
  • Being willing and willing to participate in the study,

排除标准

  • Serious bleeding and major hematoma development in the femoral region,
  • Not applying intracoronary stent or coronary angioplasty after coronary angiography,
  • Vital signs are abnormal enough to prevent intervention,
  • Having visual, auditory and mental disabilities,
  • Having a communication problem,
  • Not being willing and able to participate in the study,
  • It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.

结局指标

主要结局

Pain Scores: Numerical rating scale

时间窗: "through study completion, an average of 1 year".

The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).

次要结局

  • Physiological parameter("through study completion, an average of 1 year".)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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