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IM İnjection-PAIN-Cold Spray and Stress Ball

ConditionsPain, ProceduralAcute PainInjection Site
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorErzincan Binali Yildirim Universitesi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • cold spray gruop

    Procedure/Surgery

    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.

  • stress ball gruop

    Procedure/Surgery

    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.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Cold Spray GroupExperimental treatment 1 intervention
Group C: Stress Ball GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Immediately after intramuscular injection (0-5 minutes)
2

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.

Time frame
During intramuscular injection

Secondary outcomes

1

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

The mean pain scores, as measured by the Visual Analog Scale (VAS), will be compared between the group receiving the cold spray intervention and the group using the stress ball. 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 indicates a better outcome.

Time frame
Immediately after intramuscular injection (0-5 minutes)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erzincan Binali Yildirim Universitesi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: