Buzzy Application During Heel Blood Collection in the Newborn

NCT ID: NCT06773325

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2024-11-30

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.

Conditions

Buzzy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Buzzy

Group Type: EXPERIMENTAL

Buzzy application

Intervention Type: BEHAVIORAL

Buzzy application during heel prick blood collection

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Buzzy application

Buzzy application during heel prick blood collection

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Veysel Can

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Van Yüzüncü Yıl University

Van, Tuşba, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Buzzy

Identifier Type: -

Identifier Source: org_study_id