NCT06607575

The Effect of Warming and Vibration Applications on Pain in Newborns

The Effect of Warming and Vibration Applications on Pain During Heel Blood Collection in Newborns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns. H1: Warming application has a positive effect on pain during heel blood collection in newborns. H2: Vibration application has a positive effect on pain during heel blood collection in newborns. H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.

Detailed description

Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain. Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Control group	1. The procedure for heel blood collection will be performed. 2. Pain assessment will be performed with the N-PASS scale during and after the procedure.
OTHER	Warming	1. The cotton sock will be warmed under the heater for 3 minutes. The sock will be put on the newborn and taken off after 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.
OTHER	Vibration	1. A rechargeable toothbrush will be prepared for the newborn to whom vibration will be applied. The vibration process will be applied to the midline of the gastrocnemius muscle for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.
OTHER	Warming and vibration	1. After the socks are warmed, they will be put on the newborn\'s feet and both warming and vibration will be applied for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-03-12
• Completion: 2025-03-12
• First posted: 2024-09-23
• Last updated: 2025-05-06

Locations

2 sites across 1 country: Turkey (Türkiye)