Vibration and ShotBlocker to Reduce Pain and Fear During IM Injections in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized study compares three approaches for handling pain and anxiety during intramuscular injections in children in the emergency department: vibration, ShotBlocker, and a control. A total of 120 participants will be enrolled and evenly allocated to the three groups, with pain intensity as the primary outcome. The study uses a priori power analysis to ensure adequate sample size for detecting differences among groups. Results will inform whether these non-pharmacological methods can meaningfully lessen procedural pain and fear in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Volunteering of the child and parent to participate in the study,
* Children the ages between 5-10,
* Having intramuscular (IM) injection.

Exclusion Criteria:

* Communication problem,
* Children with any chronic illness,
* Taking any medication that has an analgesic effect at least 6 hours before applying.

Where it's running

• Burdur Mehmet Akif Ersoy University
  Burdur, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Selda A ATES BESIRIK, PhD. — Burdur Mehmet Akif Ersoy University
• Study coordinator: Selda ATES BESIRIK, PhD. Study Principal Investigator, Assist. Prof.
• Email: seldaates07@gmail.com
• Phone: +905543683323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.