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NCT Number: NCT07262463

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

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.

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Key information

Conditions

Intramuscular Injection Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muğla Sıtkı Koçman University, Fethiye Faculty Of Health Sciences, Department of Nursing

Muğla, Fethiye, 48300, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Intramuscular Injection

Other

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.

Manual Pressure Technique

Procedure

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.

Traction-Pressure-Release (TPR) Technique

Procedure

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.

Primary outcomes

  1. Pain intensity after intramuscular injection

    Time frame: Immediately after injection (within 1-2 minutes)

    Pain intensity will be measured using the 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Participants will mark their pain level immediately after the intramuscular injection. The distance (mm) from the left end of the scale to the participant's mark will be recorded as the pain score.

Secondary outcomes

  1. Injection satisfaction level

    Time frame: Immediately after injection (within 1-2 minutes)

    Satisfaction will be measured using a 100-mm Visual Satisfaction Scale, where 0 indicates "very dissatisfied" and 100 indicates "very satisfied." Participants will mark their satisfaction immediately after the injection.

  2. Relationship between fear of injection and experienced pain

    Time frame: Immediately after injection

    Participants' reported history of injection fear (Yes/No), recorded on the Patient Information Form, will be analyzed in relation to post-injection VAS pain scores.

Sponsors and collaborators

Lead sponsor

Melek Sahin

Other

Collaborators

  • Pamukkale University

Registry information

Official study title

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

Acronym: IM-PainTech

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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