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临床试验/NCT07233694
NCT07233694尚未招募不适用

The Effects of Cold Spray and Stress Ball Methods on Perceived Pain, Comfort, and Satisfaction During Intramuscular Injection: A Randomized Controlled Trial

Erzincan Binali Yildirim Universitesi1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Assessment of Pain Intensity Using the Visual Analog Scale (VAS) Following a Cold Spray Intervention

研究概览

简要总结

Brief Summary:

Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.

详细描述

Study Description

Brief Summary:

Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.

Detailed Description:

Intramuscular (IM) injection is a fundamental method for delivering drugs directly into muscle tissue for systemic circulation. It is one of the most common invasive procedures in clinical practice globally, with over 12 billion applications annually. While offering faster absorption and higher bioavailability compared to oral and other parenteral routes for various pharmacological agents like vaccines, analgesics, sedatives, and antibiotics, IM injection can cause pain during administration, affecting patient comfort. This pain is a frequently reported side effect and can lead to injection phobia, non-adherence to treatment, and avoidance of health services. Consequently, managing pain during IM injections is a crucial ethical and professional responsibility for nurses.

研究设计

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

盲法说明

The personnel responsible for drug administration are unaware of the treatment group allocations.

Apart from the parties mentioned above, no further blinding was implemented

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

  • •Adults aged 18-65 years
  • •Receiving intramuscular injection
  • •Voluntarily agreed to participate in the study

排除标准

  • •Skin disease at the injection site
  • •Allergy to cold spray
  • •Cognitive impairment preventing cooperation

研究组 & 干预措施

Control Group

No Intervention

No additional intervention will be applied to the participants in this group; only the standard IM injection protocol will be followed.

Cold Spray Group

Experimental

Prior to the injection, cold spray was applied to an approximately 10 cm² area at the planned injection site from a distance of 15 cm for a duration of 5 seconds. Following this procedure, the intramuscular (IM) injection was administered within 15 seconds, and the entire process was completed in accordance with the standard protocol

干预措施: cold spray gruop (Procedure)

Stress Ball Group

Experimental

Participants in this group were informed in advance about how to use the stress ball. After the ventrogluteal (VG) injection site was randomly selected, a medium-firm stress ball was placed in the hand on the non-injection side. Participants were instructed to rhythmically squeeze and release the ball throughout the procedure. The injection was then administered according to the predetermined standard protocol

干预措施: stress ball gruop (Procedure)

结局指标

主要结局

Assessment of Pain Intensity Using the Visual Analog Scale (VAS) Following a Cold Spray Intervention

时间窗: Immediately after intramuscular injection (0-5 minutes)

Pain intensity will be measured using the Visual Analog Scale (VAS). The VAS is a 100-millimeter horizontal line where 0 mm represents 'no pain' and 100 mm represents 'the worst imaginable pain'. A lower score on the VAS indicates a better outcome (less pain).

Assessment of Pain Intensity Using the Visual Analog Scale (VAS) During a Stress Ball Intervention

时间窗: During intramuscular injection

Squeezing a stress ball during intramuscular (IM) injection reduces the intensity of injection-related pain. Pain will be measured using the VAS.

次要结局

  • Comparison of Pain Intensity Scores Between the Cold Spray and Stress Ball Intervention Groups(Immediately after intramuscular injection (0-5 minutes))

研究者

发起方
Erzincan Binali Yildirim Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

handan aydın kahraman

Asistant Professör

Erzincan Binali Yildirim Universitesi

研究点 (1)

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