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临床试验/NCT03645369
NCT03645369已完成不适用

The Effectiveness of Mechano-Analgesia and Cold Application

Istanbul Saglik Bilimleri University0 个研究点目标入组 165 人开始时间: 2015年3月2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
165
主要终点
Pain Intensity Measure via VAS

研究概览

简要总结

Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.

详细描述

The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).

All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

This study was conducted on receiving treatment patients in the Orthopedics and Traumatology wards of a university hospital.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Must be older than 18 years
  • •Open to communication
  • •No complications during the operation
  • •Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and
  • •Platelet count (150.000-300.000)
  • •Give consent to participate in the study

排除标准

  • •Oral and parenteral anticoagulant treatment for at least 5 days
  • •Infection, scar tissue or incision, and parenteral treatment in their abdominal area
  • •Hematological and allergic disease

研究组 & 干预措施

Mechano-Analgesia

Experimental

The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.

干预措施: ShotBlocker (Device)

Cold Application

Experimental

The second SC heparin injections were applied from the left abdominal region with an ice pack

干预措施: Ice pack (Device)

Control

No Intervention

The second SC heparin injections were applied from the lower abdominal region without any additional application

结局指标

主要结局

Pain Intensity Measure via VAS

时间窗: Immediately after injection

The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher.

次要结局

未报告次要终点

研究者

发起方
Istanbul Saglik Bilimleri University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Demet İnangil, PhD

Principal Investigator

Istanbul Saglik Bilimleri University

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