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Completed

NCT Number: NCT04674982

Vibration and During Heel Lance Procedures in Newborns

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

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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep University

Gaziantep, 27000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a vibrating device

Device

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

Primary outcomes

  1. G Power software was used to calculate the sample size of the study.

    Time frame: 5 days

    G Power

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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