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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2025-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Traction-Pressure-Release and Manual Pressure on Intramuscular Injection Pain

NCT07262463

Intramuscular Injection Pain

COMPLETED NA

Rapid Injection Technique Without Aspiration

NCT03723421

Pain

COMPLETED NA

Necessity of Aspiration in the Ventrogluteal Site

NCT04421599

Nursing Injection Site

UNKNOWN NA

IM İnjection-PAIN-Cold Spray and Stress Ball

NCT07233694

Pain, Procedural Acute Pain Injection Site

NOT_YET_RECRUITING NA

Comparison of the Efficacy of Shotblocker and Acupressure in Reducing Pain Due to Intramuscular Injection

NCT05456945

Acute Pain İnjection Acupressure +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Pain Injection Site Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Procedure:

Each participant will receive two injections, one into each ventrogluteal muscle. One side will be randomly assigned to the Z-track method, the other to the TPR method, using coin toss randomization. All injections will be administered by the same researcher using 3 mL of diclofenac sodium with a 21G (0.80x38 mm) needle. Injection speed will be 1 mL per 10 seconds.

For the 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.

For the 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.

A second blinded researcher will immediately measure leakage diameter with a millimeter ruler and evaluate

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TPR method

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Z-track method

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes