Clinical Trial

IM İnjection-PAIN-Cold Spray and Stress Ball

Study acronym: CSB-PAIN
Not Yet Recruiting
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Record status
This record was last updated November 18, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Brief Summary: Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.
Trial Details
NCT Number NCT07233694
Lead Sponsor Erzincan Binali Yildirim Universitesi
Conditions Pain, Procedural, Acute Pain, Injection Site
Enrollment 66 participants
Start Date 2025-11-25
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12-10 (estimated)
Updated on ClinicalTrials.gov 2025-11-18