Non-Pharmacological Methods in Heel Lance

Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.

Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Heel Lance Procedures
• Intervention / Treatment: Behavioral: Foot bath

Detailed Description

This study was designed to investigate the effects of three different non-pharmacological interventions applied prior to heel lance on the vital parameters and pain levels of newborns. The study population consists of term newborns who meet the inclusion criteria, and the sample includes newborns who present with their parents to a state hospital for heel lance and meet these criteria. Following ethical approval, data will be collected between November 2025 and November 2026. Data collection will be carried out by Özlem Kum, a graduate student actively working in the relevant clinic and responsible for performing the procedures.

Pain will be assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates procedural pain in both preterm and term newborns. The scale includes five behavioral indicators (facial expression, leg movement, arm movement, crying, and state of arousal) and one physiological indicator (respiratory pattern), with total scores ranging from 0 to 7. A 16-item Information Form containing maternal and neonatal characteristics will also be used. Statistical analyses will be performed using SPSS version 26, including frequency, percentage, mean, standard deviation, t-test, ANOVA, and Pearson correlation analyses.

Heel lance is one of the most frequently performed invasive procedures in the neonatal period. The pain and stress experienced during this procedure may lead to changes in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management strategies is essential for improving the quality of nursing care.

Non-pharmacological methods such as warm foot bath, ShotBlocker®, and the Buzzy® device are commonly used to reduce procedural pain through different mechanisms, including increased peripheral circulation, mechanical stimulation, vibration, and cold application. However, studies comparing the effects of these methods on newborns' heart rate, respiratory rate, oxygen saturation, and pain levels are limited.

This study will be conducted with approximately 90 clinically stable term newborns (37-42 weeks of gestation) in the Neonatal Unit of Kocaeli City Hospital. Data will be collected at three time points-before, during, and after the procedure-and changes in heart rate, respiratory rate, and oxygen saturation will be recorded. With parental consent, the procedure will be video-recorded at all stages, and anonymized recordings will be shared with experts for pain assessment.

The findings of this study are expected to contribute to the identification of effective non-pharmacological methods that can be used during painful procedures such as heel lance and to support the development of evidence-based practices in neonatal nursing.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sermin Dinc, Dr.; Phone Number: +90 5424033430; Email: sermin.dinc@atlas.edu.tr
• Study Contact Backup: Name: sermin dinç, Dr.; Phone Number: +90 5424033430; Email: sermindnc@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kağıthane
    • Istanbul, Kağıthane, Turkey (Türkiye), 34098
      • Recruiting
      • Atlas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Newborns with a gestational age of ≥37 weeks
• Newborns in the neonatal period (0-28 days)
• Stable vital signs
• Obtained informed consent from the parents
• No use of analgesics or sedatives within the 24 hours before the procedure
• Absence of any respiratory problems
• First-time heel lance procedure
• No condition that would interfere with pain assessment

Exclusion Criteria:

• Preterm or low birth weight infants (< 2500 g)
• Infants with congenital anomalies or requiring respiratory support
• Infants receiving sedative or analgesic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buzzy; Vibration Application with Buzzy® Before Heel Lance	Behavioral: Foot bath; The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes. The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine. The video recording will be stopped once bleeding has ceased at the end of the procedure. The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.
Experimental: Shotblocker; After the information form is completed with the parent, the video recording will be initiated. The infant's vital signs will be monitored and recorded using a pulse probe, after which the ShotBlocker® will be placed on the procedure site. Following the heel lance performed with the ShotBlocker®, the time to bleeding cessation and the infant's crying duration will be recorded.	Behavioral: Foot bath; The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes. The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine. The video recording will be stopped once bleeding has ceased at the end of the procedure. The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Infant Pain Scale	Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain) moderate pain, >4 = severe pain)	0 minutes (T0)
Neonatal Infant Pain Scale	Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)	5th minutes 1st (T1)
Neonatal Infant Pain Scale	Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)	10th minutes (T2)
Heart Rate	beats/min.	0 min (T0)
Heart Rate	beats/min.	5th min 1st (T1)
Heart Rate	beats/min.	10th minutes (T2)
Respiratory rate	respiration/minute	0 min (T0)
Respiratory rate	respiration/minute	5th min 1st (T1)
Respiratory rate	respiration/minute	10th minutes (T2)
Saturation level	%100	0 min (T0)
Saturation level	%100	5th min 1st (T1)
Saturation level	%100	10th minutes (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The infant's crying duration	minutes	From start to end of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the procedure	minutes	From start to end of the procedure

Collaborators and Investigators

• Sponsor: Atlas University
• Investigators: Principal Investigator: sermin dinç, Dr., Atlas University

Publications and helpful links

Helpful Links

• The effect of the ShotBlocker® and breastfeeding on pain and comfort level during heel lance procedure in newborns: randomized controlled trial

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2026
• Primary Completion (Actual): February 25, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: heel lance; Foot Bath; Buzzy; Shotblocker
• Other Study ID Numbers: E-22686390-050.99-84286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No