Vibration and During Heel Lance Procedures in Newborns

University of Gaziantep

Status: Completed

Conditions: Heel Lance Procedures

Treatments: Device: a vibrating device

Study type: Interventional

Funder types: Other

Identifier

NCT04674982

Details and patient eligibility

About

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

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Full 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.

Enrollment: 56 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Vibration Group

Experimental group

Description:

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.

Treatment:

Device: a vibrating device

Control Group

No Intervention group

Description:

No interventions were made on the newborns in the control group during the heel lance procedure.