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

NCT07262463 | Completed

• 1 other identifier: E-60116787-020-612652
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intramuscular injection; Pain; Manual pressure; TPR technique; Ventrogluteal site

Outcome Measures

Primary Outcomes (1)

• Pain intensity after intramuscular injection

  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.

  Immediately after injection (within 1-2 minutes)

Secondary Outcomes (2)

• Injection satisfaction level

  Immediately after injection (within 1-2 minutes)

• Relationship between fear of injection and experienced pain

  Immediately after injection

Study Arms (3)

Standard Intramuscular Injection (Control Group)

OTHER

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.

Other: Standard Intramuscular Injection

Manual Pressure Technique

EXPERIMENTAL

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.

Procedure: Manual Pressure Technique

Traction-Pressure-Release (TPR) Technique

EXPERIMENTAL

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.

Procedure: Traction-Pressure-Release (TPR) Technique

Interventions

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.

Standard Intramuscular Injection (Control Group)

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.

Manual Pressure Technique

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.

Traction-Pressure-Release (TPR) Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melek Sahin: lead
• Pamukkale University: collaborator

Study Sites (1)

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

Muğla, Fethiye, 48300, Turkey (Türkiye)

Location

Related Publications (4)

• Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.

  PMID: 31452229 RESULT

• Cmc S, Lord H, Vargese SS, Kurian N, Cherian SA, Mathew E, Fernandez R. Effectiveness of physical stimulation for reducing injection pain in adults receiving intramuscular injections: a systematic review and meta-analysis. JBI Evid Synth. 2023 Feb 1;21(2):373-400. doi: 10.11124/JBIES-20-00590.

  PMID: 36758552 RESULT

• Ozturk D, Baykara ZG, Karadag A, Eyikara E. The effect of the application of manual pressure before the administration of intramuscular injections on students' perceptions of postinjection pain: a semi-experimental study. J Clin Nurs. 2017 Jun;26(11-12):1632-1638. doi: 10.1111/jocn.13530. Epub 2016 Nov 24.

  PMID: 27535654 RESULT

• Salari M, Estaji Z, Akrami R, Rad M. Comparison of skin traction, pressure, and rapid muscle release with conventional method on intramuscular injection pain: A randomized clinical trial. J Educ Health Promot. 2018 Dec 28;7:172. doi: 10.4103/jehp.jehp_216_18. eCollection 2018.

  PMID: 30693308 RESULT

MeSH Terms

Conditions

Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 20, 2024
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)