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IM İnjection-PAIN-Cold Spray and Stress Ball

NCT07233694 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Pain, Procedural
  • Acute Pain
  • Injection Site

Interventions

PROCEDURE

cold spray gruop

Arm Description: Before skin cleansing; cooling spray will be applied to a 10 cm2 area in the injection area from a distance of 15 cm for 5 seconds and diclofenac sodium injection will be applied within 15 seconds (Çetin and Avşar, 2022; Cevheroğlu and Büyükyılmaz, 2023). • IM injection protocol will be followed.

PROCEDURE

stress ball gruop

The patients in the group will first be told how to use the ball. After the VG area to be injected is determined, a stress ball will be given to the patient's hand opposite the injection area and they will be asked to squeeze and loosen the ball. They will be told to repeat this until the procedure is completed.

Sponsors & Collaborators

  • Erzincan Binali Yildirim Universitesi

    lead OTHER

Principal Investigators

  • Handan AYDIN KAHRAMAN, PHD · Erzincan Binali Yildirim Universitesi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2025-11-30
Completion
2025-12-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233694 on ClinicalTrials.gov