An interventional study of a vibrating device in Heel Lance Procedures, sponsored by University of Gaziantep. Completed at 1 site in Turkey. Open to participants aged 1 Day to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Supportive care
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.
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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.
University of Gaziantep is the lead sponsor of 100 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the vibration group, a vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) was applied to the middle/side area through which the sural nerve passes immediately below the knee of the extremity from which heel blood was to be collected approximately 30 seconds prior to commencement of the heel lance procedure. The vibration was continued throughout the heel lance procedure unless there was redness, swelling, bruising or a change in the skin integrity in the area to which the vibration was applied, and the vibration was stopped once the procedure was over.
Device: a vibrating device
No interventions were made on the newborns in the control group during the heel lance procedure.
vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)
G Power software was used to calculate the sample size of the study.
G Power
Time frame: 5 days
Plan to share: Undecided
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Gaziantep