Non-Pharmacological Methods in Heel Lance

NCT07348731 | Not Yet Recruiting DMC

• 1 other identifier: E-22686390-050.99-84286
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heel Lance Procedures

Keywords

Foot Bath; Buzzy; Shotblocker; heel lance

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• The infant's crying duration

  From start to end of the procedure

Other Outcomes (1)

• Duration of the procedure

  From start to end of the procedure

Study Arms (2)

Buzzy

EXPERIMENTAL

Vibration Application with Buzzy® Before Heel Lance

Behavioral: Foot bath

Shotblocker

EXPERIMENTAL

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

Interventions

Foot bath BEHAVIORAL

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.

Buzzy; Shotblocker

Eligibility Criteria

• Age: 4 Days - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University

Istanbul, Kağıthane, 34098, Turkey (Türkiye)

Location

Related Links

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

Study Officials

• sermin dinç, Dr.

  Atlas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sermin Dinc, Dr.

CONTACT

5424033430; sermin.dinc@atlas.edu.tr

sermin dinç, Dr.

CONTACT

5424033430; sermindnc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: January 16, 2026
• Study Start: February 25, 2026
• Primary Completion: February 25, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)