NCT07081048 Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns
| NCT ID | NCT07081048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tarsus University |
| Condition | Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 159 participants in total. It began in 2025-03-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim: The study was designed to determine the effect of Buzzy® and Shotbloker® application on pain and comfort levels in newborns during heel pricking. Method:The study was a randomised controlled trial. The study sample consisted of 159 newborns (Buzzy: 53, Shotbloker: 53, control: 53) who had heel pricks between March 2025 and December 2025 at the Samandağ State Hospital Neonatal Care Unit. The data collection tools used will be the Newborn Information Form, the Newborn Pain Scale, the Newborn Comfort Behaviour Scale, and the Buzzy® and Shotbloker® devices. In the intervention group, the Buzzy® and Shotbloker® devices will be applied before and after heel pricking, while the control group will receive routine care. The infants' pain and comfort levels will be assessed by the nurse before and after the procedure.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07081048 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 1 Month, studying Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07081048 currently recruiting?
Yes, NCT07081048 is actively recruiting participants. Contact the research team at duygusduzkaya@tarsus.edu.tr for enrollment information.
Where is the NCT07081048 trial being conducted?
This trial is being conducted at Mersin, Turkey (Türkiye).
Who is sponsoring the NCT07081048 clinical trial?
NCT07081048 is sponsored by Tarsus University. The trial plans to enroll 159 participants.