Vibration and During Heel Lance Procedures in Newborns

Heel Lance Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674982
• Status: Completed
• Phase: N/A
• Start date: September 9, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: December 2020
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Heel Lance Procedures

Intervention

Device:
• a vibrating device
vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)

Locations

Country	Name	City	State
Turkey	Gaziantep University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

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