Effects of TPR Technique and Z Technique on Pain and Drug Leakage in Intramuscular Injections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cumhuriyet University
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Pain with visual analog scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: 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.
Intervention: Z-track method (Other)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Hulya Kocyigit
Phd, Research Assitant
Cumhuriyet University