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临床试验/NCT04411992
NCT04411992Unknown不适用

The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-Blind, Randomized Cross-over Study

Istanbul Medeniyet University0 个研究点目标入组 84 人开始时间: 2020年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
84
主要终点
the effects of vibration on intramuscular injection-induced pain

研究概览

简要总结

Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16 billion treatments are performed through injection per year all over the world. Approximately 95% of these injections are administered for therapeutic purpose. There is no study result in the literature on the effect of vibration on pain in the ventrogluteal region in particular.

详细描述

Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16 billion treatments are performed through injection per year all over the world. Approximately 95% of these injections are administered for therapeutic purpose.

If IM injections are not administered properly, they cause many complications such as primarily pain and cellulitis, muscular fibrosis and contracture, abscesses, tissue necrosis, granuloma, hematoma, and nerve injuries.Painful injections may lead to the development of fear and needle phobia. People are not able to comply with the treatment due to fear and needle phobia and they may even reject treatment. Pain developing after IM injection may vary based on drug content, individual factors and injection technique.

It has been reported that patients feel less pain and the other complications decrease when the correct technique of IM injection is selected. Different pain relief methods such as local ice application, changing needle before injection and acupressure are employed during injection. In the literature, mechano-analgesia, which is known as the skin stimulation methods, is included in pain management in addition to these methods.

One of the mechano-analgesia methods is vibration. The pain-relief mechanism of vibration is explained with the gate control theory. The theory, which is a similar mechanism used to obtain pain relief by rubbing an area near an injury, using TENS, or acupuncture. In the studies, it has been explained by the fact that the sense of touch and vibration obtained from skin receptors stimulate the intermediary inhibitor neurons in medulla spinalis through A-β nerve fibres. These neurons reduce the pain level in A-delta and A-C fibres in transmitting the signal received from skin to the second neuron, the signal cross over medulla spinalis and rises to brain. There are studies in the literature explaining that pain is reduced by vibration. Also, the vibration has advantages over other methods such as TENS, acupuncture as it is a method that is easy to apply, simple, applicable in all hours, and cheap and does not require any preparation.

Although the results of the related studies have indicated that this new method is effective in reducing injection pain, the number of studies on this method in the literature is limited. There is no study result in the literature on the effect of vibration on pain in the ventrogluteal region in particular.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

All the measurement scores were obtained by another researcher blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years old and over
  • •had no communication problem,
  • •had a body mass index (BMI) of 18.5 to 30 kg/m2,
  • •not injected in ventrogluteal region in the last two weeks
  • •not have any pain, hematoma, necrosis, scar, incision or infection symptoms on skin in ventrogluteal region

排除标准

  • •Have ppain, hematoma, necrosis, scar, incision or infection symptoms on skin in ventrogluteal region
  • •injected in ventrogluteal region in the last two weeks
  • •not want to participate.
  • •body mass index (BMI) of under 18.5 and up 30 kg/m2,
  • •have psychological illness

研究组 & 干预措施

Allocated to Vibration intervention (1) A

Experimental

Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .

干预措施: Vibrating Device (Device)

Allocated to Control intervention (1) B

No Intervention

The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.

Allocated to Vibration intervention (2) B

Experimental

Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .

干预措施: Vibrating Device (Device)

Allocated to Control intervention (1) A

No Intervention

The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.

结局指标

主要结局

the effects of vibration on intramuscular injection-induced pain

时间窗: Three months

Pain will be measures with Visual Analog Scale (VAS). The scale is composed of a 10-cm vertical or horizontal line, which starts with "No pain" on the one edge and ends with "worst pain" on the other edge. Patients should be informed about the use of VAS very well. Patients are asked to indicate the pain level by marking the appropriate point on the line.

the effects of vibration on satisfaction for intramuscular injection

时间窗: Three months

patient satisfaction will be measured with Visual Analog Patient Satisfaction Scale .Visual patient satisfaction scale is combined with the characteristics of the well-known VAS (Visual Analog Scale). It is composed of a 100-mm horizontal line without numbers.

次要结局

未报告次要终点

研究者

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

Berna Dincer

Assistant Prof.

Istanbul Medeniyet University

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