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临床试验/NCT05972811
NCT05972811尚未招募不适用

Investigation of the Effect of Cold Application on Pain Caused by Jackson Pratt Drain Removal in Patients With Kidney Transplantation

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
1
主要终点
Pain evaluated using the Visual Analog Scale (VAS)

研究概览

简要总结

The study was planned as a prospective, randomized controlled study to examine the effect of cold application on pain due to Jackson Pratt drain removal in kidney transplant patients.

详细描述

During kidney transplant surgery, a Jackson Pratt Drain (JP) is placed in the surgical field to monitor lymphocele and urinary leakage. This drain is a closed system that opens outward from the skin at a point close to the incision line. This drain is removed by pulling when the drainage amount falls below 30 ml. This procedure is known to cause serious pain. In our study, which was planned as a prospective, randomized controlled study, it was aimed to examine the effect of cold application in the pain caused by the removal of the JP drain in patients with kidney transplantation. The population of the study will be patients who had a kidney transplant in İstinye University Hospital Liv Hospital Organ Transplant Center (n=76). In the study, patients will be assigned to the experimental and control groups by the block randomization method. "Patient Information Form" and "Visual Analog Scale" (VAS) will be used as data collection tools. In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. Then, the drain removal process will be performed by the physician. In the control group, no application will be made. In both study groups before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned. Chi-square and t-tests will be used to compare demographic data in the analysis process of the data. ANOVA test will be applied to compare pain scores between groups.

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 (Care Provider)

盲法说明

The application will be made by the researcher. However, pain assessment will be done by the nurse who cares for the patient.

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

  • Being between the ages of 18-65,
  • Being conscious, oriented to person, place and time,
  • No history of mental pathology,
  • No history of drug or alcohol use,
  • Having a body mass index of <30 kg/m2,
  • Not using any analgesic or sedative medication one hour before drain removal.

排除标准

  • IV analgesic or sedative treatment during cold application,
  • Having a history of chronic pain,
  • Having previous drain removal experience,
  • Refusal to participate in the research,
  • Unstable hemodynamic status.

结局指标

主要结局

Pain evaluated using the Visual Analog Scale (VAS)

时间窗: Pain measurement will be made with VAS just before drain removal, immediately after drain removal, and 15 minutes later.

According to this scale, "0" indicates no pain, "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe pain.

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

Ufuk Akkurt

PhD (c), Department of Nursing

Karadeniz Technical University

研究点 (1)

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