Buzzy Application During Heel Blood Collection in the Newborn

Not Applicable

Completed

• Conditions: Buzzy

• Registration Number: NCT06773325
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

Objective The aim of this study was to evaluate the effects of Buzzy device application during heel prick blood collection on pain level and comfort in newborns.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between September and November 2024 using a randomized controlled experimental design. The study sample consisted of 80 newborn infants born at 37-42 weeks gestational age and within the first 28 days of birth (Buzzy group: n = 40, control group: n = 40). The Buzzy group was treated by placing the Buzzy device approximately 30 seconds before heel prick blood collection. In the control group, routine heel prick was performed without any application. Neonatal introduction form, Neonatal Infant Pain Scale and Neonatal Comfort Behavior Scale were used for data collection.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Those in the neonatal period between 0-28 days,
• voluntary participation of the parent,
• between 37-42 weeks of gestational age
• babies with vital signs within normal limits

Exclusion Criteria

• The integrity of the skin in the area where the device was to be implanted was compromised,
• Nerve damage or deformity in the extremity to be heel bled,
• Genetic - with a congenital anomaly or congenital metabolic disorder,
• undergoing cardiopulmonary resuscitation,
• No heel prick on the first attempt,
• with osteogenesis imperfecta and infants given analgesics in the last 6 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The Neonatal Infant Pain Scale	pre-test post-test (approximately three months)	min-max (0-7) , fewer points is a good result

Trial Locations

Locations (1)

Van Yüzüncü Yıl University; 🇹🇷 VAN, Tuşba, Turkey