Intramuscular Injection Pain
Conditions
Keywords
Intramuscular injection, Pain, Manual pressure, TPR technique, Ventrogluteal site
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.
Interventions
OTHERStandard 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.
PROCEDUREManual 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.
PROCEDURETraction-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.
Sponsors
Pamukkale University
Melek Sahin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity after intramuscular injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Injection satisfaction level | 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. |
| Relationship between fear of injection and experienced pain | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed