Effects of TPR Technique and Z Technique on Pain and Drug Leakage in Intramuscular Injections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Pain with visual analog scale
研究概览
简要总结
This randomized, triple-blind clinical trial compares the effectiveness of Z-track and TPR (traction-pressure-release) techniques in reducing pain and medication leakage during ventrogluteal intramuscular injections. Pain is measured using VAS, and leakage is assessed with a millimeter scale. The study aims to identify a more efficient, less painful injection method.
详细描述
Introduction
Intramuscular (IM) injections are widely used for delivering medications due to their high bioavailability and quick absorption. However, they can cause significant local complications, especially pain, which may affect patient compliance. Various non-pharmacological techniques have been developed to reduce injection pain, including the Z-track method and the more recent TPR (traction-pressure-release) technique, based on the gate control theory of pain. While both aim to minimize pain, TPR has shown promise but lacks research regarding its effect on drug leakage.
Objective
The study aims to compare the effectiveness of TPR and Z-track techniques in reducing pain and drug leakage during IM injections in the ventrogluteal site.
Method: This study is a triple-blind, randomized, two-group clinical trial with a parallel design. A total of 76 patients aged 16-40, prescribed with intramuscular diclofenac sodium, will be recruited. Each participant will receive both techniques-TPR and Z-track-in randomly assigned ventrogluteal muscles. Pain intensity will be measured using a Visual Analog Scale (VAS), and drug leakage will be assessed using millimetric paper and a ruler. All injections will be administered by the same nurse, and evaluation will be performed by blinded assessors.
Conclusion: This research seeks to provide evidence on the efficacy of the TPR technique as a potentially time- and cost-effective alternative to Z-track, particularly in minimizing injection-related pain and leakage, thereby improving patient comfort and treatment adherence.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 16-40
- •Prescribed diclofenac sodium
- •No communication impairments
- •Healthy ventrogluteal muscles without sensory issues
排除标准
- •Wounds, redness, bruising, tenderness, or stiffness at the injection site
- •Injection in the past 2 weeks
- •Neuropathy or other medical conditions
- •BMI below 15 or above 35
研究组 & 干预措施
TPR (traction-pressure-release) technique
Intervention Type: Intramuscular drug administration with TPR technique Intervention Name: Diclofenac Sodium
TPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.
干预措施: TPR method (Other)
Z-track method
Intervention Type: Intramuscular drug administration with Z-track method Intervention Name: Diclofenac Sodium Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.
干预措施: Z-track method (Other)
结局指标
主要结局
Pain with visual analog scale
时间窗: Within 5 minutes after intramuscular injection
Pain intensity measured with the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
次要结局
- Drug leakage(Time Frame: Immediately after injection (within 1 minute)Description: Drug leakage will be observed immediately after intramuscular injection by checking the injection site for any visible medication leakage.)
研究者
Hulya Kocyigit
Phd, Research Assitant
Cumhuriyet University