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

NCT07004166 | Recruiting

• 1 other identifier: 15.05/2025 C
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Pain; Injection Site Pain

Keywords

Intramuscular Injection; Drug Leakage l; Pain; Z-Track; TPR Techniques

Outcome Measures

Primary Outcomes (1)

• Pain with visual analog scale

  Pain intensity measured with the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

  Within 5 minutes after intramuscular injection

Secondary Outcomes (1)

• 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.

Study Arms (2)

TPR (traction-pressure-release) technique

EXPERIMENTAL

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.

Other: TPR method

Z-track method

EXPERIMENTAL

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 After aspiration and injection, the needle will be withdrawn and the skin released immediately.

Other: Z-track method

Interventions

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 After aspiration and injection, the needle will be withdrawn and the skin released immediately.

Z-track method

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.

TPR (traction-pressure-release) technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (2)

Sivas Numune Hospital

Sivas, 58000, Turkey (Türkiye)

RECRUITING

Sivas State Hospital

Sivas, 58000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Myalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Şeyda Kazanç, Phd

  but no location

  STUDY DIRECTOR

Central Study Contacts

Hülya KOÇYİĞİT KAVAK, Phd

CONTACT

90555408876; hkocyigit@cumhuriyet.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Research Assitant

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 4, 2025
• Study Start: June 15, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 25, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)