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临床试验/NCT05647889
NCT05647889已完成不适用

Investigation of the Effect of Jet Lidocaine and Ice Application on Reduction of Pain and Anxiety Related to Peripheral Venous Catheterisation in Adult Patients: A Randomised Controlled Trial

Ataturk University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Visual Analogue Scale for Pain (VAS-P)

研究概览

简要总结

Investigation of the Effect of Jet Lidocaine and Ice Application on Pain and Anxiety in Peripheral Venous Catheterization (PVC). The research will be carried out experimentally with a single group post-test method. The universe of the research; Between June-December 2022, all patients who need peripheral venous catheterization (PVK) for the treatment plan will be formed in the internal clinics of Gümüşhane State Hospital. The sample of the study will consist of 80 patients from the defined population who meet the inclusion criteria. Power analysis was used to determine the number of samples in the study. First of all, patients who are hospitalized in the internal clinics of Gümüşhane State Hospital and who meet the inclusion criteria will be determined. Written and verbal consent will be obtained for their participation by giving information about the research. PVK application will be applied to all patients by the same investigator. Each patient will create their own control group in order to control individual differences in pain and anxiety. In the study consisting of two intervention and a control group; The same patients will be included in the intervention groups and the control group. Randomization will be done to determine the order of intervention to be applied to the patients. The interventions for each patient will be numbered by the researcher and the order of procedure will be determined by drawing lots. After the cephalic vein for the first attempt is randomly determined, the other extremity vein will be used while performing consecutive PVC applications. To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.

详细描述

This study was planned as a randomized controlled, single-blind experiment. The research will be carried out in the internal clinics of Gümüşhane State Hospital. Internal clinics were preferred because patients hospitalized in surgical clinics experienced intense pain and anxiety due to surgical operations. The universe of the research; All patients who are hospitalized in the relevant clinics within the specified time period and who need to apply PVC for the treatment plan will be formed.

The sample of the research; It will consist of 80 patients who are hospitalized in internal clinics, who need PVC for diagnosis or treatment, and who meet the research criteria. Power analysis was used to determine the number of samples in the study.The data of the research; Patient Information Form will be collected using the Visual Analog Scale for Pain (VAS-P), Visual Analog Scale for Anxiety (VAS-A), Wong-Baker Faces Pain Rating Scale. Nursing Intervention: The research will be conducted experimentally with a single group post-test method. First of all, patients who meet the criteria for inclusion in the study will be determined, and written and verbal consent will be obtained for their participation by giving information about the research. PVC application will be applied to all patients by the same investigator. Each patient will create their own control group in order to control individual differences in pain and anxiety. In the study consisting of two intervention and a control group; The same patients will be included in the intervention groups and the control group. Randomization will be done to determine the order of intervention to be applied to the patients. Interventions will be numbered for each patient and the order of procedure will be determined by drawing lots. After the cephalic vein for the first attempt is randomly determined, the other extremity vein will be used while performing consecutive PVC applications. To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.

Intervention group-I (Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later) Intervention group-II (Ice application will be made for 1 minute before PVC and then PVC will be performed) It will be named as the control group (Standard PVC procedure will be applied)

Process steps

Control group PVC Application Steps

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Able to speak and understand Turkish,
  • Those between the ages of 18-50,
  • Demanding peripheral venous catheter insertion,
  • Having lidocaine request before PVC,
  • Having no problems with vision and hearing,
  • No history of secondary acute pain other than peripheral venous catheter,
  • Having no physical barrier to insertion of a catheter from the cephalic veins,
  • Not allergic to lidocaine and cold,
  • No signs of phlebitis, scar tissue, dermatitis, incision and infection in the area to be operated,
  • No history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain,
  • Individuals without coagulation disorder, liver failure, kidney and cardiovascular failure will be included in the study.

排除标准

  • Cannot speak or understand Turkish,
  • Those who are outside the age range of 18-50,
  • No request for peripheral venous catheter insertion,
  • No lidocaine request before PVC,
  • Having any problems with vision and hearing,
  • Having a history of any secondary acute pain other than peripheral venous catheter,
  • Having a physical obstacle to insertion of a catheter from the cephalic veins,
  • Those who are allergic to lidocaine and cold,
  • With phlebitis, scar tissue, dermatitis, incision and infection findings in the area to be operated,
  • Having a history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain,
  • Patients with coagulation disorder, liver failure, kidney and cardiovascular failure

研究组 & 干预措施

Jet lidocaine group

Experimental

Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later.

干预措施: Jet lidocaine (Drug)

Ice group

Experimental

Ice will be applied for 1 minute before PVC, and then PVC will be performed.

干预措施: Ice (Combination Product)

Control group

Active Comparator

Standard PVC procedure will be applied

干预措施: Standard PVC procedure (Other)

结局指标

主要结局

Visual Analogue Scale for Pain (VAS-P)

时间窗: Within 1 minute after PVC application

It is a scale used to evaluate the severity of pain. It is a 100 mm ruler with painlessness at one end and the most severe pain at the other. "0" denotes painlessness, and "100" denotes the most severe pain.A low score from the scale indicates that the application is beneficial.

次要结局

  • Visual Analogue Scale for Anxiety (VAS-A)(Within 1 minute after PVC application)

研究者

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

Esra Aydın

Lecturer

Ataturk University

研究点 (2)

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