Clinical Trials Directory

Trials / Completed

CompletedNCT04674982

Vibration and During Heel Lance Procedures in Newborns

The Effect of Vibration on Pain During Heel Lance Procedures in Newborns

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University of Gaziantep · Academic / Other
Sex
All
Age
1 Day – 30 Days
Healthy volunteers
Accepted

Summary

This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns. .

Detailed description

Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.

Conditions

Interventions

TypeNameDescription
DEVICEa vibrating devicevibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)

Timeline

Start date
2018-09-09
Primary completion
2018-12-12
Completion
2018-12-12
First posted
2020-12-19
Last updated
2020-12-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04674982. Inclusion in this directory is not an endorsement.