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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-11-10

Brief Summary

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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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Detailed Description

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Conditions

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Intramuscular Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel-group, single-blind randomized controlled design with three independent arms. Participants are randomly assigned in a 1:1:1 ratio to one of the following groups: (1) Standard intramuscular injection (control), (2) Manual Pressure technique, or (3) Traction-Pressure-Release (TPR) technique. Each participant receives only one type of intervention, and no crossover or repeated interventions are applied. Outcomes (pain intensity and injection satisfaction) are measured immediately after the injection using validated visual scales. Randomization is performed using block randomization to ensure balance among groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Intramuscular Injection (Control Group)

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.

Group Type OTHER

Standard Intramuscular Injection

Intervention Type 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

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.

Group Type EXPERIMENTAL

Manual Pressure Technique

Intervention Type 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

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.

Group Type EXPERIMENTAL

Traction-Pressure-Release (TPR) Technique

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes