Vibration and During Heel Lance Procedures in Newborns

NCT ID: NCT04674982

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-09
• Study Completion Date: 2018-12-12

Brief Summary

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

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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.

Conditions

Heel Lance Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Vibration Group

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.

Group Type: EXPERIMENTAL

a vibrating device

Intervention Type: DEVICE

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

a vibrating device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gaziantep

OTHER

Sponsor Role: lead

Responsible Party

Elif BİLSİN KOCAMAZ

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.

Reference Type: DERIVED

PMID: 34334677 (View on PubMed)