跳至主要内容
临床试验/NCT06662240
NCT06662240已完成不适用

Effect of Vibration Anesthesia on Pain, Ecchymosis and Comfort Level in Subcutaneous Heparin Injection

Ataturk University1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年3月15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
142
试验地点
1
主要终点
Patient Introduction Form

研究概览

简要总结

The aim of this study is to determine the effect of vibration anesthesia on injection pain, ecchymosis and comfort level in subcutaneous heparin injection.This study was conducted in a randomized controlled experimental design.

详细描述

Population and Sample of the Research

The population of the research consisted of the doses administered by subcutaneous heparin injection in the chest diseases clinic of Atatürk University Health Research and Application Center. Among the total data related to the study, 162 patients were evaluated. There were 28 patients who met the study eligibility criteria and 18 who refused to participate in its terms. 116 patients who volunteered to comply with the data collection, total fee criteria and participate will be assigned to the experimental group, 58 patients to the control group, and 58 patients to the control group by randomization. 8 patients from the experimental group left the study because they were discharged early. In the control group, 6 patients were discharged early rather than 2 patients in the study. Training data was completed with 50 patients in both experimental and control classes. To determine whether the sample size was sufficient, post-hoc power analysis was calculated with the G*Power 3.1.9.7 program.

Post hoc power analysis of the study was determined to be over 0.90 with a margin of error of 0.05 for the analysis conducted on the basis of t test in independent groups of the 2nd combination application. Completed with 50 patients in both the experimental and control groups. Post-hoc power analysis was calculated with the G*Power 3.1.9.7 program to determine whether the sample size was sufficient. The power of the study was determined to be above 0.90 with a margin of error of 0.05 for the post hoc power analysis based on the t test in independent groups for the 2nd injection application.

Inclusion Criteria

  • Clexane (Enoxaparin Sodium) 0.6 ml SC 1x1 DMAH treatment (0.6 ml heparin was preferred because pain and ecchymosis may be less at a dose of 0.4 ml heparin and the incidence of pain and ecchymosis may increase at a dose of 0.8 ml Clexane.
  • No cognitive, physical or mental impairment that prevented them from answering the questions,
  • 18 years of age or older,
  • No previous known coagulation disorders,
  • Platelet value between 150,000 and 300,000/millimeter cubed,
  • PTZ value between 10-14 seconds,
  • aPTT value between 20-40 seconds,
  • INR value between 0.8-1.2,
  • No incision, infection, ecchymosis, hematoma, scar tissue in the abdominal region
  • No needle phobia
  • Not taking pain medication in the last 12 hours
  • No abdominal pain
  • No other invasive procedures in the abdominal region
  • SC heparin not administered by subcutaneous, intramuscular or intradermal injection,
  • Patients with no known allergy to heparin,
  • Patients with a body mass index above 18.5 were included in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient Introduction Form

时间窗: 7 months

It is a form prepared in line with the literature that includes the information of the patients (gender, age, marital status, educational status, employment status, body mass index, chronic disease, continuous medication use, smoking status).

Visual Analog Pain Scale

时间窗: 7 months

The Visual Analog Scale (VAS) is a scale system used to convert some characteristics that cannot be quantitatively measured into numerical values. VAS pain was used to measure the intensity of pain during injection. The VAS pain scale is expressed as "0=No pain, 10=Unbearable pain" on a 10 cm horizontal line. Patients were asked to mark the intensity of pain experienced during subcutaneous injection with an X on the scale. It is a widely used valid scale.

Visual Analog Comfort Scale

时间窗: 7 months

The VAS comfort is a 10 cm long horizontal measurement tool that starts with "most comfortable" and ends with "most uncomfortable". Patients rated their comfort level with this scale. For a better understanding of the term comfort by patients, they were asked to indicate their "comfort, satisfaction or level of comfort with the injection" on the scale. It is a valid scale widely used to assess comfort.

Patient Follow-up Form

时间窗: 7 months

The patient follow-up form records the date and time of the injection, the patient's name or pseudonym, the group to which the patient belongs, the standard injection method with or without vibration, the injection site, pain intensity, comfort level and ecchymosis size.

Ecchymosis Measurement Tool

时间窗: 7 months

A transparent measuring tool was used to measure the ecchymosis at the injection site. The transparent measuring tool was placed on the ecchymosis and the borders of the ecchymosis were drawn with an acetate pen; then, the size of the ecchymosis was determined in mm2 by placing the transparent measuring tool on a millimeter measuring paper and recorded on the patient follow-up form. The size of the ecchymosis was measured at 48 hours after injection. It is reported that ecchymosis after subcutaneous heparin injection is most prominent after 48 hours. Based on the literature, discoloration smaller than 2 mm2 was considered as "no ecchymosis", and the size of discoloration of 2 mm2 or more was measured.

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

Meltem SIRIN GOK

assistant professor

Ataturk University

研究点 (1)

Loading locations...

相似试验