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临床试验/NCT05822336
NCT05822336已完成不适用

The Relationship Between Pain Intensity and Intramuscular Injection

Biruni University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Facial Pain Expressions Scale

研究概览

简要总结

This study was a single-group crossover clinical trial, where each participant acted as their own control. The study aimed to describe the relationship between perceived pain and the duration of intramuscular injections

详细描述

The study was a single-group crossover clinical trial, where each participant acted as their own control. The study sample included 50 patients aged 25 to 55 who met the inclusion criteria of signing an informed consent form and requiring administration of a specific antibiotic via intramuscular injection, as prescribed by physicians.

Two intramuscular injections into the right and left Dorsal Gluteal Region (DRG) were recorded for each participant. One was administered by a nurse, according to the unit's routine, and took 5 seconds to complete. A day after, the same nurse gave the other injection in the opposite DGR, taking 40 seconds to administer. The five-second injections were considered the control group, while the 40 seconds injections were the intervention group. The order of interventions was randomized. The pain level was determined and recorded immediately after each injection.

The study was conducted between September 2019 to November 2019 in the emergency unit of an educational hospital in Istanbul. The data was collected using a Demographic Form, Facial Expressions Scale, and Visual Comparison Scale. Statistical analysis was performed using the Kolmogorov-Smirnov test, Mann-Whitney U test, Wilcoxon test, and Spearman correlation analysis, with a significance level of p < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Participant)

盲法说明

Single blind masking

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

  • Having a condition leads to prescribing Clindamycin 600 mg/4 ml intramuscularly Having no pain in the area of injection Absence of any tissue damage history at the site of injection

排除标准

  • Asking for withdrawal after signing the informed consent Intensifying the disease/condition at the time of the second injection Taking any analgesic medication before the application.

结局指标

主要结局

Facial Pain Expressions Scale

时间窗: after implamention in 1-2 seconds

Between one to ten

Visual Pain Comparison Scale

时间窗: after implamention in 1-2 seconds

Six level: Between zero to six

次要结局

未报告次要终点

研究者

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

Leman Şenturan

Prof. Dr.

Biruni University

研究点 (2)

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