Effects of TPR and Z Techniques on Pain and Drug Leakage in Intramuscular Injections

Not Applicable

Recruiting

• Conditions: Muscle Pain; Injection Site Pain

• Registration Number: NCT07004166
• Lead Sponsor: Cumhuriyet University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2025-06-15
• Primary Completion: 2025-08-20
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Aged 16-40
• Prescribed diclofenac sodium
• No communication impairments
• Healthy ventrogluteal muscles without sensory issues

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain with visual analog scale	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.

Secondary Outcome Measures

Name	Time	Method
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.	millimeter ruler to assess medication leakage

Trial Locations

Locations (2)

Sivas Numune Hospital; 🇹🇷 Sivas, Turkey

Sivas State Hospital; 🇹🇷 Sivas, Turkey