CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
ShotBlocker +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06380556
NCT06380556N/ACompleted

The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates: A Randomized Controlled Trial

Istanbul Medeniyet University·interventional·Posted Apr 24, 2024·Updated Apr 24, 2024

In Brief

A clinical study evaluating ShotBlocker and Mechanical vibration for Procedural Pain. Completed, enrolled 108 participants across 1 site.

Detailed Summary

This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProcedural Pain
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 24, 2024
Enrollment StartNov 10, 2022
Primary CompletionJan 30, 2023
Study CompletionJul 13, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.2 years ago

Interventions

ShotBlockerdevice

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 blood collection procedure was performed.

Mechanical vibrationdevice

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 baby's extremity and routine capillary blood collection procedure was performed.