Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns
ConditionNewborn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorTarsus University
About this trial
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
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Buzzy®.Group
Other interventionThe ice pack, which has been removed from the deep freezer in advance, should be left at room temperature for 10 minutes, and the hole in the ice pack should be placed on the hook behind the Buzzy® will be placed on the lateral side of the left heel and activated for 30 seconds. After 30 seconds, Buzzy® will be pulled up 1 centimetre (cm), and the heel will be punctured with a sterile lancet to collect blood on the Guthrie card. After the heel blood collection procedure, Buzzy® will be pulled back to the punctured heel area and left for another 30 seconds.
ShotBlocker Group
Other interventionShotBlocker will be placed on the designated area for collecting the baby's heel blood. After ensuring that the protrusions of the ShotBlocker are in contact, pressure will be applied for 20 seconds. The heel will be punctured with a sterile lancet in the area designed for applying the ShotBlocker, and the ShotBlocker will be removed from the area. The blood collected will be collected on Guthrie paper.
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: Buzzy® GroupExperimental treatment 1 intervention
Group B: Shotbloker® GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) was developed by Lawrence and colleagues in 1993. Its validity and reliability in Turkish were established by Akdovan in 1999 (81). Reliability values were found to be 0.83, 0.83, and 0.86 before, during, and after the procedure, respectively. The neonatal infant pain scale assesses facial expressions (0; relaxed, 1; distressed), crying (0; no crying, 1; whimpering, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0; relaxed-free, 1; flexion-extension), legs (0; relaxed-free, 1; flexion-extension), and sleep-wakefulness (0; sleeping-awake and calm, 1; restless). Pain is assessed based on the total score. After observation, the scale is scored from a maximum of 7 to a minimum of 0. According to the scale, a score of 7 indicates the highest level of pain, while a score of 0 indicates the lowest level of pain. If the NIPS score is between 0 and 2, the pain is considered to be absent or mild. If the pain score is between 3 and 4, i
Time frame
1 day2
Newborn Information Form
The information form has been prepared by reviewing the relevant literature and includes the baby's gestational age, gender, birth weight, birth length, mode of delivery, pre- and post-procedure physiological parameters (SPO2, pulse), NIPS Pain Score, and Newborn Comfort Behaviour Scale. The data collection form contains a total of 6 questions.
Time frame
1 day3
Newborn Comfort Behaviour Scale (NCBS)
The scale was first developed in 1992 by Ambuel and colleagues to assess distress in patients receiving mechanical ventilator support in a paediatric intensive care unit. Later, in 2009, Van Dijk and colleagues revised the scale and established the validity and reliability of the COMFORTneo scale for measuring behaviour in newborns without physiological parameters. The COMFORTneo scale (NCBS) consists of 6 parameters (alertness, calmness/agitation, The COMFORTneo scale (YKDÖ) is a Likert-type scale consisting of six parameters (alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, muscle tone). It is also a tool that provides nurses with numerical data to assess the comfort of newborns. The scale was revised in 2014 by Karaman et al. to establish its 'Turkish Validity and Reliability.' The lowest score on the scale is 6 and the highest score is 30, with high scores indicating that the baby is not comfortable. The Cronbach's alpha coefficient of t
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov