Effect of Traction-Pressure-Release and Manual Pressure on Intramuscular Injection Pain (IM-PainTech)

Melek Sahin

Status: Completed

Conditions: Intramuscular Injection Pain

Treatments: Other: Standard Intramuscular Injection; Procedure: Manual Pressure Technique; Procedure: Traction-Pressure-Release (TPR) Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07262463

E-60116787-020-612652

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.

• Hospitalized in the Orthopedics, General Surgery, or Orthopedics Clinic at Servergazi State Hospital.
• Prescribed intramuscular diclofenac sodium (3 mL).
• Has not received any intramuscular injection in the previous week.
• Able to understand instructions and accurately use the Visual Analog Scale (VAS).
• Provides written informed consent.

Exclusion criteria

• Presence of pain, abscess, infection, tissue necrosis, hematoma, or any complication related to previous intramuscular injections at the ventrogluteal site.
• Impaired consciousness or communication difficulties.
• Visual or hearing impairment that prevents accurate scale assessment.
• Any physical condition preventing proper positioning of the extremities for IM injection.
• Declines to participate or withdraws consent at any time.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 3 patient groups

Standard Intramuscular Injection (Control Group)

Other group

Description:

Control Group: Participants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The 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 the medication (diclofenac sodium, 3 mL) will be delivered at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales.

Treatment:

Other: Standard Intramuscular Injection

Manual Pressure Technique

Experimental group

Description:

Manual Pressure Group: Participants in this arm will receive the intramuscular (IM) injection using the Manual Pressure technique. Before needle insertion, the non-dominant thumb will apply firm pressure to the identified ventrogluteal injection site for 10 seconds. Following skin cleaning with an alcohol swab, diclofenac sodium (3 mL) will be 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 will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales.

Treatment:

Procedure: Manual Pressure Technique

Traction-Pressure-Release (TPR) Technique

Experimental group

Description:

TPR Group: Participants in this arm will receive the intramuscular (IM) injection using the Traction-Pressure-Release (TPR) technique. After skin cleaning, the syringe is held in the dominant hand. As the needle is inserted at a 90-degree angle, the non-dominant hand simultaneously applies skin traction with deep pressure, followed by rapid muscle release. After aspiration, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 21G, 38 mm needle. The dominant hand remains stable throughout. Pain and satisfaction will be measured immediately after the injection using validated visual scales.

Treatment:

Procedure: Traction-Pressure-Release (TPR) Technique