CompletedNot Applicable

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

Turkey (Türkiye)174 participantsStarted 2024-12-20

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain intensity after intramuscular injection

Timeframe: Immediately after injection (within 1-2 minutes)

Trial details

NCT IDNCT07262463

SponsorMelek Sahin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-10

View on ClinicalTrials.gov More Intramuscular Injection Pain trials