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NCT Number: NCT07004166

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Numune Hospital, Sivas, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z-track method

Other

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.

TPR method

Other

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 outcomes

  1. Pain with visual analog scale

    Time frame: 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 outcomes

  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.

    millimeter ruler to assess medication leakage

Study contacts

Contact information is provided by the study sponsor or research team.

Hülya KOÇYİĞİT KAVAK, Phd

CONTACT

[email protected]

90555408876

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Acronym: TPR_Z_PainLeak

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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