Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

NCT07081048 | Recruiting

• 1 other identifier: 2025/03
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn

Keywords

pain; confort; Buzzy; Shotbloker

Outcome Measures

Primary Outcomes (3)

• 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

  1 day

• 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.

  1 day

• 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

  1 day

Study Arms (3)

Buzzy® Group

EXPERIMENTAL

The 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®. 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.

Other: Buzzy®.Group

Shotbloker® Group

EXPERIMENTAL

ShotBlocker 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.

Other: ShotBlocker Group

Control Group

NO INTERVENTION

Without any intervention or application to the heel area, the lateral side of the left foot will be punctured with a lancet of the same type, and heel blood sampling will be performed according to the clinic's routine practice. At the clinic, heel blood sampling is performed without any intervention, with the baby in the mother's arms.

Interventions

Buzzy®.Group OTHER

The 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.

Buzzy® Group

ShotBlocker Group OTHER

ShotBlocker 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.

Shotbloker® Group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• • Inal, S., Aydin Yilmaz, D., & Erdim, L. (2022). The effectiveness of swaddling and maternal holding applied during heel blood collection on pain level of healthy term newborns; randomized controlled trial. Early Child Development and Care, 192(13), 2066-2077.

  BACKGROUND

• Yavas S, Bulbul T, Topcu Gavas H. The effect on pain level and comfort of foot massages given by mothers to newborns before heel lancing: Double-blind randomized controlled study. Jpn J Nurs Sci. 2021 Oct;18(4):e12421. doi: 10.1111/jjns.12421. Epub 2021 Apr 20.

  PMID: 33880884 BACKGROUND

• van der Burg S, Oerlemans A. Fostering caring relationships: Suggestions to rethink liberal perspectives on the ethics of newborn screening. Bioethics. 2018 Mar;32(3):171-183. doi: 10.1111/bioe.12425.

  PMID: 29442381 BACKGROUND

• Sok P, Lupo PJ, Richard MA, Rabin KR, Ehli EA, Kallsen NA, Davies GE, Scheurer ME, Brown AL. Utilization of archived neonatal dried blood spots for genome-wide genotyping. PLoS One. 2020 Feb 21;15(2):e0229352. doi: 10.1371/journal.pone.0229352. eCollection 2020.

  PMID: 32084225 BACKGROUND

• Shah SR, Kadage S, Sinn J. Trial of Music, Sucrose, and Combination Therapy for Pain Relief during Heel Prick Procedures in Neonates. J Pediatr. 2017 Nov;190:153-158.e2. doi: 10.1016/j.jpeds.2017.08.003.

  PMID: 29144240 BACKGROUND

• Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.

  PMID: 18165830 BACKGROUND

• Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. doi: 10.1056/NEJM198711193172105. No abstract available.

  PMID: 3317037 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Duygu Sönmez Düzkaya, PhD

CONTACT

+903246000033; duygusduzkaya@tarsus.edu.tr

Gözde Özkan, BSC

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

TU (1)