The effect on pain level and comfort of foot massages given by mothers to newborns before heel lancing: Double-blind randomized controlled study.
Seçil Yavaş, Tülay Bülbül, Hilal Topçu Gavas
https://pubmed.ncbi.nlm.nih.gov/33880884Actively Recruiting
Phase Not Applicable
Age: 1Day - 1Month
All Genders
Healthy Volunteers
ID07081048
The Effect of Buzzy4 and Shotbloker4 on Pain and Comfort Levels in Newborns During Heel Prick Blood Sampling
Led by Tarsus University · Updated on 2025-07-23
159
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two devices, Buzzy4 and Shotbloker4, on pain and comfort levels in newborns during heel prick blood sampling. This randomized controlled trial involves 159 full-term newborns admitted to a neonatal care unit between March and December 2025. The study uses specific pain and comfort scales to assess newborn responses to these interventions compared to routine care without any device application. The trial includes three groups: one using the Buzzy4 device, which involves applying an ice pack and vibration to the heel before and after blood collection; a second group using the Shotbloker4 device, which applies pressure with protrusions before puncturing the heel; and a control group receiving standard care without intervention. Blood samples are collected from the left heel using sterile lancets, following a consistent procedure across all groups. During the study, newborns are held by their mothers, and their physiological parameters, pain, and comfort are measured before and after the heel prick. Data collection includes the Neonatal Infant Pain Scale, Newborn Comfort Behaviour Scale, and other newborn information. Statistical analysis will compare the effects among the three groups to determine differences in pain and comfort during the procedure. The study duration is from March to December 2025, with assessments occurring on the day of the heel prick.
CONDITIONS
Brief Title
Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns
Who Can Participate
Age: 1Day - 1Month
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to several days before the heel prick procedure
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility and obtain consent
Treatment
Duration - Single procedure day
Participants receive either the Buzzy®, ShotBlocker, or no intervention during the heel prick blood sampling procedure. Pain and comfort levels are assessed before and after the procedure.
1 visit (in-person) during which the heel prick and intervention occur
Trial Site Locations
Total: 1 location
1
Tarsus University
Mersin, Turkey (Türkiye), 33400
Actively Recruiting
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Research Team
D
Duygu Sönmez Düzkaya, PhD
G
Gözde Özkan, BSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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