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临床试验/NCT04210323
NCT04210323已完成不适用

Use of Shotblocker® in Subcutaneous Injecting in Chronic Spontaneous Urticaria Patients: Randomized Placebo Controlled Study

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年6月5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
90
试验地点
2
主要终点
Visual comparison scales

研究概览

简要总结

Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria.

Background: In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level.

Design: Randomized placebo controlled. Methods: Data were collected between June-November 2018 by including 90 patients out of 125 patients with Chronic Spontaneous Urticaria in Dermatology Clinic, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Patients were divided into three groups as intervention, control and shotblocker group. Patients in the placebo group were administered with the reverse side of ShotBlocker® during subcutaneous injection, and no intervention was performed in the control group. The group using ShotBlocker® for subcutaneous injection was compared with the placebo and control groups.

详细描述

In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level . It is stated in the literature that complications may be reduced significantly with appropriate technique in subcutaneous injection applications.

For this purpose, "ShotBlocker® (Bionix, Toledo, Ohio) was developed for subcutaneous and intramuscular injection applications. ShotBlocker® is a drug-free, non-invasive plastic device that can be applied for all age groups. It simulates the smaller nerves at the injection site and briefly blocks the pain gate in the central nervous system and slows down A-delta signals. ShotBlocker® is quick and easy to use, does not require any preliminary preparation, and has not been previously reported side effects. A surface of the device has a plurality of blunt spots these directly in contact with the skin. It is reported that the injection pain is reduced by applying light pressure to the contacting area with a short, non-sharp 2 mm thick blunt tip. There is a gap in the middle of the device to display the injection site and injection is applied through this gap.

In most international studies, it has been found that subcutaneous and intramuscular injection with ShotBlocker® has a substantial impact on reducing pain levels. It has been found the limited number of studies have been published in Turkey in order to evaluate the effectiveness of ShotBlocker® devices in pain. In the literature review, there was not found any published research about the use of Shot Blocker® in patients with CSU who received regular subcutaneous injections.

With the results of this research, it is believed that an effective method can be presented to reduce the pain and anxiety related with subcutaneous injection and increase the level of satisfaction in CSU patients, and to contribute the development of patient care with safe practices.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Communicative
  • 18 years and older
  • Body Mass Index (BMI) between 18.5-29.9 kg / m²
  • CSU diagnosed
  • Having regular subcutaneous omalizumab treatment
  • Having not infection, scar tissue or incision on the posterior side of both upper arms and another parenteral treatment was not applied that side.
  • Having not any haematological disease
  • Volunteer to participate in the research

排除标准

  • 未提供

结局指标

主要结局

Visual comparison scales

时间窗: 60 minutes

Visual Analog Scales (VAS) were used in order to determine the pain and satisfaction of the administration. The scale comprise of a 10 cm long horizontal line with descriptive expressions at both ends (0 cm: no pain / no satisfaction and 10 cm on the right end: unbearable pain / very satisfied). Participants were asked to mark the pain level on this line.

次要结局

  • The state-trait anxiety inventory form TX-I(1 week)
  • Visual comparison scales(1 week)

研究者

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

Merve Kolcu

Assistant Professor, Director

Saglik Bilimleri Universitesi

研究点 (2)

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