Reducing heel‑prick pain and improving comfort in newborns with Buzzy or ShotBlocker

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 randomized controlled trial will enroll 159 full‑term newborns and randomly assign them to three groups: Buzzy, ShotBlocker, or routine care (53 per group). The assigned device will be applied before and after a standard heel‑prick blood draw, with all samples collected from the left lateral foot by the same nurse to ensure consistency. Pain will be measured using the Neonatal Infant Pain Scale (NIPS) and comfort using the Neonatal Comfort Behaviour Scale, recorded immediately before and after the procedure. The trial will take place in the participating neonatal unit during the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The baby must be full-term (38-42 weeks),
* No analgesic administration up to 8 hours prior to the procedure,
* No pain prior to the procedure,
* No chronic or metabolic disease,
* Born at least 24 hours prior,
* Being in the hospital during the study period

Exclusion Criteria:

* The baby is not full-term,
* Analgesic medication has been administered within 8 hours prior to the procedure,
* The baby has a chronic or metabolic disease,
* The baby requires oxygen support,
* The baby cannot be fed orally,
* The baby is not in the hospital on the dates the study will be conducted and the parents do not agree to participate in the study.

Where it's running

• Tarsus University
  Mersin, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Duygu Sönmez Düzkaya, PhD
• Email: duygusduzkaya@tarsus.edu.tr
• Phone: +903246000033

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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.