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临床试验/NCT06443099
NCT06443099已完成不适用

The Effect of Cold Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain: A Randomized Controlled Trial

Necmettin Erbakan University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2024年7月10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
120
试验地点
2
主要终点
injection pain

研究概览

简要总结

In this study, it is aimed to compare cold needle and shotblocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. June September 2024, the universe of the research will be composed of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital for cyanocobalamin injection. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. Intramuscular injection of the deltoid November will be applied to the intervention-1 group with a cold needle, intervention-2 group with a shotblocker, and the control group with the standard method. People will be determined by block randomization. After each application, the pain and satisfaction due to the injection will be evaluated. The data will be compared between the groups.

详细描述

This study aims to compare cold injection and ShotBlocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. The population of the research will consist of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital to receive cyanocobalamin injection between June and September 2024. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. The data of the study will be collected with the "Patient Diagnosis Form", "Visual Analog Scale (VAS)" and "Injection Satisfaction Scale". Block randomization method will be used to assign participants to groups. All injections will be performed by a single nurse working in the injection unit in accordance with the research procedure. Once the injection procedure is completed, participants will be asked to rate injection pain and satisfaction. Pain assessment will be performed by another emergency nurse who is independent from the study and contributes to the study. Researchers will participate in this process as observers. The people who will perform the application and evaluate the pain and satisfaction will be different. In this way, the person evaluating the pain will not know which application was performed on the participant, and blinding will be ensured. Additionally, the data of the study will be coded as A, B and C and entered into SPSS, thus ensuring statistical blinding. Thus, it is planned to conduct the research with triple blinding. All injections will be made using cyanocobalamin injection (1 ml), 5 cc syringe, 25 Gauge orange syringe tip. Before the injection, it will be checked whether the pain score is "0" with VAS. The participant will be given a Fowler position, the deltoid area will be checked on the arm to be treated, the arm will be flexed and brought closer to the body, and the position will be given. Injections will be given to each group according to the IM injection application protocol. Intramuscular injection will be applied to the deltoid muscle in the intervention-1 group, with a cold needle, in the intervention-2 group, with a shot blocker, and in the control group, with the standard method. Subjects will be determined by block randomization. All participants will be allowed to rest for two minutes after each injection. After two minutes, they will be asked to mark the level of pain caused by the procedure on the VAS. Similarly, they will be asked to mark their satisfaction with the procedure on the injection satisfaction scale. Then, the line marked by the person will be measured with a 10 cm ruler and the numerical equivalent of pain and satisfaction will be determined. Data will be compared between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

入选标准

  • Being between the ages of 18-65,
  • No problems with speaking and understanding Turkish,
  • Body mass index (BMI) between 18.5 and 30,
  • Just starting the first dose of cyanocobalamin treatment,
  • No history of allergy to the drug,
  • No vision, hearing or perception problems,
  • Having orientation to place and time,
  • No sensorimotor deficit,
  • No history of diabetes,
  • Not taking oral or parenteral analgesic treatment before the application,
  • VAS score before injection is "0",
  • No deficiency in limbs,
  • No pregnancy,
  • Female individuals who are not in their menstrual cycle,
  • Volunteering to participate in the research.

排除标准

  • Another injection into the deltoid area,
  • Development of drug-related allergy or other complications,
  • Scar, incision, infection, sensitivity, burn, cut, etc. in the injection area. to be found,
  • Wants to leave the research.

结局指标

主要结局

injection pain

时间窗: up to 2 months

Visual Pain Scale (Visual Analog Scale-VAS) is a reliable measurement tool developed to measure individuals' pain levels. The scale is simple, interesting, quick to fill out, and easy to score. There are subjective descriptive expressions at both ends of a 10-cm ruler (0: lowest pain level and 10: highest pain level). The patient will be asked to mark the place on the line that expresses his/her pain.

次要结局

  • injection satisfaction(up to 2 months)

研究者

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

Yadigar Ordu

Doctor of Teaching Member

Necmettin Erbakan University

研究点 (2)

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