NCT07262463

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

The Effect of Traction-Pressure-Release (TPR) and Manual Pressure Methods on Intramuscular Injection Pain and Satisfaction in Adults: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Melek Sahin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate whether two different intramuscular (IM) injection techniques-Manual Pressure and Traction-Pressure-Release (TPR)-can effectively reduce injection-related pain and improve patient satisfaction in adult hospitalized patients receiving diclofenac sodium (3 mL) via IM injection. The main questions the study aims to answer are: Does the TPR technique reduce IM injection pain more effectively than the standard method? Does the Manual Pressure technique reduce IM injection pain more effectively than the standard method? How are patients' fear of injection and experienced pain related? Since there is a comparison group, researchers will compare three arms (Control, Manual Pressure, TPR) to determine whether either technique results in lower pain scores and higher satisfaction compared with the standard IM injection procedure. Participants will: Receive diclofenac sodium via IM injection in the ventrogluteal site using one of three randomized techniques: * Standard IM injection (Control) * Manual Pressure technique * Traction-Pressure-Release (TPR) technique Rate their pain using the Visual Analog Scale (VAS) immediately after the injection. Rate their satisfaction using the Injection Satisfaction Scale. Provide demographic and clinical data through a Patient Information Form. This study uses a single-blind randomized controlled trial design with three parallel groups. A total of 174 adult patients will be enrolled to ensure adequate power for statistical comparison.

Conditions

• Intramuscular Injection Pain

Interventions

Type	Name	Description
OTHER	Standard Intramuscular Injection	Participants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The IM injection will be administered into the ventrogluteal site using a 5 mL syringe with a 21G, 38 mm needle. The injection area will be cleaned with an alcohol swab, and diclofenac sodium (3 mL) will be injected at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique is applied. Pain and satisfaction are assessed immediately after the injection using validated visual scales.
PROCEDURE	Manual Pressure Technique	In this intervention, firm manual pressure is applied to the ventrogluteal injection site using the non-dominant thumb for 10 seconds prior to needle insertion. After cleaning the skin with an alcohol swab, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 5 mL syringe with a 21G, 38 mm needle. No traction or rapid muscle release is performed. Pain and satisfaction are measured immediately after the injection using validated visual scales.
PROCEDURE	Traction-Pressure-Release (TPR) Technique	In this intervention, the IM injection is administered using the Traction-Pressure-Release (TPR) technique. After preparing the site with an alcohol swab, the needle is inserted at a 90-degree angle while the non-dominant hand applies simultaneous skin traction and deep pressure to the injection site. Immediately after needle insertion, the muscle is rapidly released, followed by aspiration and injection of diclofenac sodium (3 mL) at a rate of 1 mL per 10 seconds. The dominant hand holding the syringe remains stable throughout the procedure. Pain and satisfaction are assessed immediately after the injection using validated visual scales.

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: Turkey (Türkiye)