振动联合冷冻疗法对成人疫苗相关疼痛和焦虑水平的影响：一项随机临床试验研究方案。
Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial.
机构信息
Department of Medicine and Nursing, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.
Health Division, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil.
出版信息
Trials. 2022 Aug 1;23(1):620. doi: 10.1186/s13063-022-06564-7.
BACKGROUND
Vaccination is one of the most effective strategies for prevention and eradication of immunopreventable diseases, but community acceptance of vaccination can be influenced by different factors, such as pain and anxiety. The use of high-frequency vibration associated with cryotherapy has been used to manage pain and anxiety during the vaccination process in children, but studies with adults are still scarce. This study aims to evaluate the effect of high-frequency vibration associated with cryotherapy on the levels of self-reported pain and anxiety related to administration of the Influenza vaccine intramuscularly in adults.
METHODS
A two-arm, parallel, randomized clinical trial conducted in a Brazilian Primary Health Care Unit is proposed. A sample of 350 adults will be randomly assigned to participate in the control group, receiving the vaccine intramuscularly according to the standard protocol of the service, or in the intervention group, receiving the vaccine by the same route and using a portable device of high frequency vibration associated with cryotherapy for 30 s before and during administration. The primary endpoints will be self-reported levels of pain, assessed before and after vaccine administration. Secondary endpoints will be levels of anxiety, satisfaction with vaccine administration, and discomfort caused by high frequency vibration and temperature of the frozen bag in contact with the skin. Self-reported levels of pain and anxiety will be compared before and after vaccination as well as between the control and intervention groups.
DISCUSSION
By evaluating the effect of high-frequency vibration associated with cryotherapy on pain and anxiety levels, we expect to find evidence that will support nursing practice, in order to promote greater comfort and safety in the vaccination process and, consequently, greater compliance by the population, by minimizing its undesirable effects.
TRIAL REGISTRATION
Human Research Ethics Committee Opinion Number: 5.138.564. Approved on December 2, 2021. Brazilian Registry of Clinical Trials (REBEC): Registration number RBR-5zgy25w. Registered on December 09, 2021.
背景
接种疫苗是预防和消除可通过免疫预防的疾病的最有效策略之一，但社区对接种疫苗的接受程度可能受到不同因素的影响，如疼痛和焦虑。在儿童的疫苗接种过程中，使用与冷冻疗法相关的高频振动已被用于管理疼痛和焦虑，但针对成人的研究仍然很少。本研究旨在评估与冷冻疗法相关的高频振动在管理成人肌肉内流感疫苗接种时自我报告的疼痛和焦虑水平方面的效果。
方法
拟在巴西的一个基层医疗单位开展一项双臂、平行、随机临床试验。将招募 350 名成人，随机分配到对照组，按照服务的标准方案肌肉内接种疫苗；或干预组，以相同的途径接种疫苗，并在接种前和接种期间使用便携式高频振动与冷冻疗法联合设备 30 秒。主要终点将是自我报告的接种前后疼痛水平。次要终点将是焦虑水平、疫苗接种满意度、高频振动引起的不适以及与皮肤接触的冷冻袋的温度。将比较接种前后以及对照组和干预组之间的自我报告的疼痛和焦虑水平。
讨论
通过评估与冷冻疗法相关的高频振动对疼痛和焦虑水平的影响，我们希望找到支持护理实践的证据，以便在疫苗接种过程中促进更大的舒适度和安全性，从而提高人群的依从性，最大限度地减少其不良影响。
试验注册
人体研究伦理委员会意见编号：5.138.564。于 2021 年 12 月 2 日批准。巴西临床试验注册处（REBEC）：注册号 RBR-5zgy25w。于 2021 年 12 月 9 日注册。
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