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临床试验/NCT06563648
NCT06563648已完成不适用

The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction

Bornova No. 25 Mevlana Family Health Center1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2022年1月1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
208
试验地点
1
主要终点
Visual analog scale

研究概览

简要总结

The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection.

详细描述

The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection. The research was conducted with 208 patients hospitalized in the Cardiology and Internal Medicine clinics at Izmir Atatürk Training and Research Hospital between April 2022 and April 2024. Patients were assigned to four groups: ShotBlocker (n=52), ShotBlocker placebo (n=52), local cold application (n=52) and control (n=52) groups using the randomization algorithm.

A ShotBlocker was placed on the arm of the patients in the ShotBlocker group during the injection, and the injection was performed from the part where the opening was located by lightly pressing with the fingertips throughout the injection. During the injection, the back side of the ShotBlocker was placed on the arm of the patients in the ShotBlocker placebo group and the injection was performed by gently pressing with the fingertips throughout the injection. Local cold application was applied to the arm of the patients in the local cold application group for five minutes using a cold pack, and then the injection was performed. Patients in the control group were injected with a routine subcutaneous injection procedure. In all groups, the injection took 30 seconds and was performed by researcher. At the first minute after the injection, the patients were evaluated about the pain they felt during the injection and their satisfaction with the injection by a different reseacher. Data were collected by face-to-face interview technique using an informed consent form, individual identification form, visual analog scale and visual patient satisfaction scale. Ethics committee permission, institutional permission and written permission from the patients were obtained for the implementation of the research. Number, percentage, median, mean, and standard deviation, Mann Whitney U test, Kolmogorov-Smirnov test, Kruskal Wallis H test, Bonferroni and chi-square test were used in the analysis of the data.

研究设计

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Enoxaparin sodium 1x1 0.6 ml. SC treatment
  • •Over 18 years of age
  • •No vision or hearing problems
  • •No scar tissue, incision, lipodystrophy or infection at the injection site

排除标准

  • •Underwent mastectomy
  • •Not being voluntering

研究组 & 干预措施

ShotBlocker group

Experimental

A ShotBlocker was placed on the arm of the patients in the ShotBlocker group during the injection, and the injection was performed from the part where the opening was located by lightly pressing with the fingertips throughout the injection.

干预措施: shotblocker (Other)

ShotBlocker placebo group

Experimental

During the injection, the back side of the ShotBlocker was placed on the arm of the patients in the ShotBlocker placebo group and the injection was performed by gently pressing with the fingertips throughout the injection.

干预措施: ShotBlocker placebo group (Other)

Local cold application group

Experimental

Local cold application was applied to the arm of the patients in the local cold application group for five minutes using a cold pack,and then the injection was performed.

干预措施: local cold application (Other)

control group

No Intervention

Patients in the control group were injected with a routine subcutaneous injection procedure.

结局指标

主要结局

Visual analog scale

时间窗: At the first minute after the injection, the patients were evaluated about the pain they felt during the injection by a different reseacher.

The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form

次要结局

  • Visual patient satisfaction scale(At the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.)

研究者

发起方
Bornova No. 25 Mevlana Family Health Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Ince

research assistant faculty of nursing principles

Ege University

研究点 (1)

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