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临床试验/NCT07583472
NCT07583472进行中(未招募)不适用

Impact of the Helfer Skin Tap Technique on Pain and Comfort Levels During Ventrogluteal Injection: A Randomized Controlled Trial

Seyda Can1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This randomized controlled study evaluates the effect of the Helfer Skin Tap Technique on pain and comfort during ventrogluteal intramuscular injections in adults.

Participants aged 18-65 receiving diclofenac sodium injections at the Emergency Department of Yalova Training and Research Hospital will be randomly assigned to the intervention group (Helfer technique) or control group (standard injection). Pain and comfort will be measured using visual analog scales (VAS) before and after the injection.

The study aims to provide evidence for improving injection pain management and patient comfort. Participation is voluntary, and all procedures follow ethical guidelines.

详细描述

The implementation of high-risk treatments and interventions in healthcare has increasingly highlighted the concept of patient safety in recent years. Patient safety is an indicator of quality in healthcare services and has become one of the fundamental elements of providing qualified and high-quality care (Korkmaz, 2018). The growing complexity of healthcare services, changing healthcare needs, and rapid technological advancements in the field introduce multiple risks for both healthcare professionals and patients (Yıldız & Yıldız, 2020).

In the healthcare process, after medications are prescribed by the physician, nurses administer these drugs and are responsible for preparing the correct medication and delivering it to the right patient, at the right time, via the right route, in the correct dose, and for monitoring its effects (Apaydın & Öztürk, 2021). Medications can be administered via oral, topical, or parenteral routes (Turan et al., 2019). Parenteral drug administration, one of the important medication routes, involves invasive procedures and carries multiple risks (Okuroğlu et al., 2019).

Intramuscular (IM) injection, one of the parenteral routes, has been used in nursing practice for over a century and is applied by delivering the drug into deep muscle tissue (Korkmaz et al., 2018). Because muscles have a rich vascular supply, IM injections allow better absorption of the drug (Turan et al., 2019). Accordingly, the absorption and bioavailability of drugs via IM injection are higher compared to oral or other parenteral routes (Ayinde et al., 2021). IM injections require nurses to have strong knowledge in anatomy, physiology, and pharmacology, as well as good psychomotor skills (Eraydın & Karagözoğlu, 2022). Additionally, determining needle depth, syringe length, and injection speed is highly important (Turan et al., 2019).

If IM injections are not properly administered, they can cause nerve (sciatic nerve), muscle, vascular, and bone injury; abscess, erythema, scar tissue formation, hematoma, bleeding, persistent pain, cellulitis, tissue necrosis, granuloma, muscle fibrosis, contracture, and infection (Eraydın & Karagözoğlu, 2022; Tok Aydın, 2019). Nerve damage can occur directly from needle impact or indirectly due to edema or hematoma at the injection site, which exerts mechanical pressure on the nerve, or via diffusion of the drug into the nerve causing toxic effects. Antibiotics and analgesics are the most frequent causes (Bostan, 2016). The World Health Organization reports that approximately 12 billion injections are administered globally each year, with 50% given unsafely (Turan et al., 2019). Therefore, safety in IM injection administration is critically important (Turan et al., 2019).

After IM injection, pain at the injection site, anxiety, fear, dissatisfaction, or loss of privacy can reduce the acceptability of treatment for patients. Awareness that IM injections are painful may affect clinicians' preference for this route. Despite this, due to its importance in treatment, pain at the injection site remains a key concern (Ayinde et al., 2021; Eraydın & Karagözoğlu, 2022).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

In this study, only the participants are blinded to their group assignment. No other parties (such as the administering nurse or data analysts) are blinded.

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

  • Individuals who can speak and understand Turkish,
  • Individuals who are willing to participate in the study and have provided written informed consent,
  • Aged between 18 and 65 years,
  • Body Mass Index (BMI) between 18-24 kg/m²,
  • Individuals without sensory-motor deficits, diabetes, peripheral vascular disease, or neuropathy,
  • Individuals who have not received oral or parenteral analgesic treatment before the injection,
  • Individuals without ecchymosis, redness, or swelling at the injection site,
  • Individuals without orthopedic issues preventing internal rotation of extremities,
  • Individuals with intact orientation to time and place,
  • Individuals without visual or hearing impairments.

排除标准

  • Individuals who refuse to undergo the technique applied within the study after being enrolled,
  • Individuals who voluntarily withdraw from the study,
  • Individuals for whom less than 24 hours have passed since their last injecti

研究者

发起方
Seyda Can
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seyda Can

Associate Professor, PhD

University of Yalova

研究点 (1)

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