IM İnjection-PAIN-Cold Spray and Stress Ball

NCT07233694 | Not Yet Recruiting

• 1 other identifier: Handan 1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

muscle intramuscular injection; Nursing; Nursing practice; Pain; stress ball; cold spray

Outcome Measures

Primary Outcomes (2)

• Assessment of Pain Intensity Using the Visual Analog Scale (VAS) Following a Cold Spray Intervention

  Pain intensity will be measured using the Visual Analog Scale (VAS). The VAS is a 100-millimeter horizontal line where 0 mm represents 'no pain' and 100 mm represents 'the worst imaginable pain'. A lower score on the VAS indicates a better outcome (less pain).

  Immediately after intramuscular injection (0-5 minutes)

• Assessment of Pain Intensity Using the Visual Analog Scale (VAS) During a Stress Ball Intervention

  Squeezing a stress ball during intramuscular (IM) injection reduces the intensity of injection-related pain. Pain will be measured using the VAS.

  During intramuscular injection

Secondary Outcomes (1)

• Comparison of Pain Intensity Scores Between the Cold Spray and Stress Ball Intervention Groups

  Immediately after intramuscular injection (0-5 minutes)

Study Arms (3)

Control Group

NO INTERVENTION

No additional intervention will be applied to the participants in this group; only the standard IM injection protocol will be followed.

Cold Spray Group

EXPERIMENTAL

Prior to the injection, cold spray was applied to an approximately 10 cm² area at the planned injection site from a distance of 15 cm for a duration of 5 seconds. Following this procedure, the intramuscular (IM) injection was administered within 15 seconds, and the entire process was completed in accordance with the standard protocol

Procedure: cold spray gruop

Stress Ball Group

EXPERIMENTAL

Participants in this group were informed in advance about how to use the stress ball. After the ventrogluteal (VG) injection site was randomly selected, a medium-firm stress ball was placed in the hand on the non-injection side. Participants were instructed to rhythmically squeeze and release the ball throughout the procedure. The injection was then administered according to the predetermined standard protocol

Procedure: stress ball gruop

Interventions

cold spray gruop PROCEDURE

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.

Cold Spray Group

stress ball gruop PROCEDURE

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.

Stress Ball Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 years
• Receiving intramuscular injection
• Voluntarily agreed to participate in the study

You may not qualify if:

• Skin disease at the injection site
• Allergy to cold spray
• Cognitive impairment preventing cooperation

Sponsors & Collaborators

• Erzincan Binali Yildirim Universitesi: lead

Study Sites (1)

Erzincan Binali Yıldırım University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (3)

• Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.

  PMID: 33939726 RESULT

• Basak T, Demirtas A, Yorubulut SM. Virtual reality and distraction cards to reduce pain during intramuscular benzathine penicillin injection procedure in adults: A randomized controlled trial. J Adv Nurs. 2021 May;77(5):2511-2518. doi: 10.1111/jan.14782. Epub 2021 Feb 19.

  PMID: 33608955 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

MeSH Terms

Conditions

Pain, Procedural; Acute Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Handan AYDIN KAHRAMAN, PHD

  Erzincan Binali Yildirim Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Handan AYDIN KAHRAMAN, PHD

CONTACT

+905077469889; haydin@erzincan.edu.tr

Handan AYDIN KAHRAMAN, PHD

CONTACT

+90 507 746 9889; haydin@erzincan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The personnel responsible for drug administration are unaware of the treatment group allocations. Apart from the parties mentioned above, no further blinding was implemented
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professör

Model Details: The research was planned as a single-blind, randomized controlled experimental study.

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: November 18, 2025
• Study Start: November 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 10, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)