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临床试验/NCT04883723
NCT04883723已完成不适用

The Effect of Use of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in the Application of Intramuscular Injection to the Ventrogluteal Region in Adult Patients

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年4月22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
入组人数
120
试验地点
1
主要终点
Visual Benchmark Scale

研究概览

简要总结

This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. The sample of the study consisted of a total of 120 patients over the age of 18 who applied to the Emergency Service of a public hospital and were requested Diclofenac Sodium 75mg / 3ml. The patients were included in the experiment I (shotblocker), experiment II (manual compression) and the control group with the randomization list created on the computer.

In the ShotBlocker group, the ShotBlocker was kept throughout the injection, and in the manual compression group, manual pressure was applied to the injection area for 10 seconds before injection, and in the control group, IM injection was applied without using any tools. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. Visual Comparison Scale and Injection Satisfaction Scale were administered to the patient in the first minute after the injection. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Parametric or nonparametric statistical tests and correlation 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
Single (Participant)

入排标准

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

入选标准

  • •He has not had an IM injection in the last week,
  • •Upper respiratory tract infection patients in the Examination Department, where green field patients of the Emergency Service are located,
  • •Over the age of 18,
  • •No complications related to IM injections such as pain at the IM injection site, abscess, infection, tissue necrosis, hematoma,
  • •Does not have pain anywhere in the body that will affect the work result,
  • •Are conscious and have no communication problem,
  • •No vision or hearing problems,
  • •Not taking analgesic in the last 24 hours,
  • •Does not have any known chronic disease,
  • •No psychiatric disorder,
  • •Diclofenac sodium ampoule has been ordered,
  • •Can evaluate "Visual Comparison Scale and Injection Satisfaction Scale" correctly,
  • •Individuals who volunteered to participate in the study and signed the written informed consent form were included.

排除标准

  • •Not wanting to participate in the study,
  • •Patients who did not meet the study acceptance criteria were not included.

研究组 & 干预措施

Experiment I (Shotblocker) Group

Experimental

Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position. The determined injection site was cleaned with a cotton pad with alcohol, with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. The protruding surface of the Shotblocker was placed in the area just before the injection, so that the needle entry point would not be contaminated. It was lightly pressed into the shotblocker with fingertips and the injection was performed. ShotBlocker has been removed after removing the needle. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

干预措施: Shotblocker (Device)

Experiment II (Manual Pressure) Group

Experimental

Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

干预措施: Manual Pressure (Other)

Control Group

No Intervention

The patients in the Manual Pressure group were given detailed information about the procedure and the research, and the patients who agreed to participate in the study were signed by an informed consent form. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Injection was given using the normal intramuscular injection procedure. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

结局指标

主要结局

Visual Benchmark Scale

时间窗: Immediately after the injection

It is a one-dimensional scale used in the measurement of pain. It was found that the sensitivity of the visual comparison scale was higher than other methods in the assessment of pain severity. The scale consists of a 100 mm long line. On one end there are the words "No Pain" and "Unbearable Pain" on the other. The patient is instructed to mark a point on the line that accurately reflects his or her pain. Between the onset of no pain and this point marked by the patient, it is measured and recorded.

Injection Satisfaction Rating Scale

时间窗: Immediately after the injection

The satisfaction level of the patients after injection was evaluated using a scale consisting of a 100 mm vertical line with "Very Satisfied" on one end and "Not Satisfied" on the other.

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

Ali Kaplan

lecturer

TC Erciyes University

研究点 (1)

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