A Comparison of Two dıfferent Methods to Reduce ıntramuscular ınjectıon paın; Cold Spray and ShotBlocker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- The effect of ShotBlocker on intramuscular pain
研究概览
简要总结
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain.
详细描述
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain. In this study, it was used to reduce pain associated with IM injection in adults.
It was aimed to evaluate the effect of ShotBlocker and cold spray application on pain. The research is planned to be completed between February 2020 and December 2020. The universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in Malatya Turgut Özal Medical Center Emergency Service. 195 patients selected by the simple random sampling method (shotBlocker group = 39, shotBlocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. Participant Introduction Form and Visual Benchmarking Scale (VAS) were used to collect data. According to the characteristics of the data In independent groups, t test, ANOVA test, Mann Whitney U test, correlation were measured.
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
- None
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
- •Being 18 years or older
- •Communication,
- •Having no problems with vision and hearing,
- •No pain, scar tissue, incision, lipodystrophy and signs of infection in the application area,
- •Body mass index between 18.5 and 30,
- •There is no history of allergy.
排除标准
- 未提供
研究组 & 干预措施
Control Group
Control group injection process step; The individuals in this group were injected by following the routine IM injection procedure steps. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS.
Cold Spray Group
Cold spray group injection process step; In addition to the IM injection procedure steps, Cryos cold spray was applied to patients in this group after skin cleansing. Cryos cold spray sprayed 3 puffs from a distance of 20 cm to the skin, and the injection process was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS.
干预措施: Cryos REF 0971 Cold Spray (Device)
ShotBlocker Group
ShotBlocker group injection process step; In addition to the IM injection procedure steps, after cleansing the skin of the patients in this group, the protruding part of the ShotBlocker was placed in contact with the skin. ShotBlocker was pressed firmly against the skin and the injection was made through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS.
干预措施: ShotBlocker BIONIX Press Firmly USA (Device)
Cold Spray Placebo Group
Cold spray placebo group injection procedure step; In addition to the IM injection procedure steps, the patients in this group were treated with tap water in a cold spray bottle after cleansing the skin. After spraying 3 puffs of tap water in a placebo bottle at a distance of 20 cm to the skin, the injection was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS.
干预措施: Cryos REF 0971 Cold Spray (Device)
ShotBlocker Placebo Group
ShotBlocker placebo group injection procedure step; In addition to the IM injection procedure steps, in patients in this group, the non-protruding part of the ShotBlocker was placed in contact with the skin after skin cleaning. ShotBlocker was pressed firmly against the skin and the injection was applied through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed.
干预措施: ShotBlocker BIONIX Press Firmly USA (Device)
结局指标
主要结局
The effect of ShotBlocker on intramuscular pain
时间窗: About 2 months
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
The effect of cold spray on intramuscular pain
时间窗: About 2 months
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
次要结局
未报告次要终点
研究者
Zeliha CENGİZ
Principal Investigator
Inonu University