Reducing heel‑prick pain and improving comfort in newborns with Buzzy or ShotBlocker
THE EFFECT OF BUZZY® AND SHOTBLOKER® APPLICATION ON THE PAIN AND COMFORT LEVEL OF NEWBORNS DURING HEEL PRICK BLOOD SAMPLING IN NEWBORNS
This test tries whether using a small vibrating device (Buzzy) or a pressure device (ShotBlocker) before and after a heel prick can reduce pain and improve comfort for full‑term newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 1 Day to 1 Month |
| Sex | All |
| Sponsor | Tarsus University Academic / other |
| Locations | 1 site (Mersin) |
| Trial ID | NCT07081048 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Full‑term newborns (38–42 weeks), at least 24 hours old, who are in hospital during the study period, have received no analgesic in the prior 8 hours, have no chronic or metabolic disease, and show no pain before the procedure.
Not a fit: Preterm infants, babies requiring oxygen or assisted feeding, those with chronic/metabolic disease, or infants given analgesics within 8 hours prior to the procedure are unlikely to be included or to benefit from the interventions tested here.
Why it matters
Potential benefit: If successful, this could provide a simple, nonpharmacologic way to reduce pain and improve comfort during routine heel‑prick blood draws in newborns.
How similar studies have performed: Similar devices such as Buzzy have shown reduced procedural pain in older infants and children in prior trials, but evidence specifically for full‑term newborn heel‑prick sampling is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mersin
- Tarsus University — Mersin, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Duygu Sönmez Düzkaya, PhD
- Email: duygusduzkaya@tarsus.edu.tr
- Phone: +903246000033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.