The Effect of Warming and Vibration Applications on Pain in Newborns

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Control group; Other: Warming; Other: Vibration; Other: Warming and vibration

• Registration Number: NCT06607575
• Lead Sponsor: Acibadem University

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2024-10-15
• Status Verified: 2025-03
• Primary Completion: 2025-03-12
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Newborns at 38 weeks of gestation and above
• Healthy newborns

Exclusion Criteria

• Newborns with any lower extremity anomalies
• Newborns with congenital diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Newborns who will be subjected to routine practices during heel blood collection procedure and who will not be subjected to warming and vibration will constitute the control group.
Experimental group (warming)	Warming	Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group.
Experimental group (vibration)	Vibration	Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group.
Experimental group (warming and vibration)	Warming and vibration	Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group.

Primary Outcome Measures

Name	Time	Method
Change in level of pain	Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.	The level of pain will be measured using the N-PASS: Neonatal Pain/Agitation, Sedation Scale. The scale was developed by Hummel, Lawlor-Klean and Weiss in 2010, its Turkish validity and reliability were made by Açıkgöz et al. in 2017. N-PASS consists of two sections: sedation and pain assessment. Total pain score varies between 0 and +11 and total sedation score varies between 0 and +10. A high score indicates severe pain. The aim is to keep the score at 3 and below. If it is above 3 points, sedation requirements are evaluated. The average time spent to administer the scale is 1 minute.

Trial Locations

Locations (1)

Acıbadem University; 🇹🇷 İstanbul, Ataşehir, Turkey