Effects of Vibration, Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection

NCT06646848 | Completed

• 1 other identifier: GO 2024/226
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Vibration, Heel Warming, and Shotblocker on pain levels during heel blood collection on healthy term newborn's.

Conditions

Newborn; Pain Management; Vibration; Heel Warming; Shotblocker; Wounds, Penetrating; Needlestick Injuries

Keywords

Newborn; Pain; Vibration; Heel Warming; Shotblocker

Outcome Measures

Primary Outcomes (1)

• NIPS (Neonatal Infant Pain Scale)

  It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.

  (average 5 minutes) during the heel blood collection procedures (1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), and 2 min (T+2 min)

Secondary Outcomes (3)

• Crying times

  during the heel blood collection procedures (average 5 minutes)

• Processing time

  during the heel blood collection procedures (average 5 minutes)

• The time to first calming

  Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)

Study Arms (4)

Vibration Group

EXPERIMENTAL

Vibration was applied to the infants in this group before and during the heel lance procedure.

Device: Vibration

Heel Warming Group

EXPERIMENTAL

Heel warming was applied to the infants in this group before and during the heel lance procedure.

Device: Heel Warming

Shotblocker Group

EXPERIMENTAL

ShotBlocker was applied to the infants in this group before and during the heel lance procedure.

Device: Shotblocker

Control Group

NO INTERVENTION

In this group, infants received routine heel blood collection procedure.

Interventions

Vibration DEVICE

The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse punctured the heel with a needle. Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from the infants's extremity and routine heel blood collection procedure was performed.

Vibration Group

Heel Warming DEVICE

The heel warning group will warm the heel of the infants using a hot thermal bag 3-5 minutes before the application. Then, the thermal bag will be removed and the nurse will take the heel blood.

Heel Warming Group

Shotblocker DEVICE

The protruding surface of the Shotblocker was placed on the heel lance procedure site. While applying pressure on the skin through the Shotblocker, the nurse performed heel lancing with the needle through the opening in the center of the Shotblocker. During the 10-second waiting phase, the Shotblocker was kept at the procedure site with the same pressure. Then Shotblocker was removed from the skin and routine capillary heel collection procedure was performed.

Shotblocker Group

Eligibility Criteria

• Age: 2 Days - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents who volunteered and gave consent to participate in the research
• Full term neonates (38-42 weeks of gestation)
• Underwent heel stick blood drawing for routine metabolic screening,
• Aged 2 to 4 days
• Passed the hearing screening
• Birth weight between 2500-4400 grams
• Parents who know how to read, write and speak Turkish.

You may not qualify if:

• Parents with any mental problems
• Infants with any chronic disease and congenital anomalies.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Wounds, Penetrating; Needlestick Injuries; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Wounds, Stab

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: June 3, 2024
• Primary Completion: March 14, 2025
• Study Completion: May 28, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)