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Recruiting NCT07004166

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

No phase Interventional Muscle Pain Injection Site Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Z-track method, TPR method.
Who it may be relevant to
Registry conditions: Muscle Pain, Injection Site Pain. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Z-track method
    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.
  • Other TPR method
    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.

Primary outcome measures

  • Pain with visual analog scale [Time frame: Within 5 minutes after intramuscular injection]
Secondary outcome measures (1)
  • Drug leakage [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 2 centers
  • Sivas Numune Hospital — Sivas
  • Sivas State Hospital — Sivas

Identifiers

NCT: NCT07004166 · 15.05/2025 C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗