Vibration and During Heel Lance Procedures in Newborns

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04674982

Enrollment

Registered

2020-12-19

Start date

2018-09-09

Completion date

2018-12-12

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heel Lance Procedures

Keywords

newborns, vibration, pain, heel lance

Brief 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.

Interventions

DEVICEa vibrating device

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

Healthy volunteers

Yes

Inclusion criteria

* Gestational age 38 and older

Exclusion criteria

* Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected, * Genetic and congenital anomalies * Congenital metabolic disorders, * those who had undergone cardiopulmonary resuscitation, * Stayed in the neonatal intensive care unit for any reason, * Heel blood could not be collected at the first attempt, * Osteogenesis imperfecta * Had been given an analgesic within the preceding 6 hours

Design outcomes

Primary

Measure	Time frame	Description
G Power software was used to calculate the sample size of the study.	5 days	G Power

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026