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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06607575
Enrollment
140
Registered
2024-09-23
Start date
2024-10-15
Completion date
2025-03-12
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Newborn, pain, vibration, warming, heel blood collection, infant

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.

Interventions

OTHERControl 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.

OTHERWarming

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.

OTHERVibration

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.

OTHERWarming 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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

Inclusion criteria

* Healthy newborns

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in level of painImmediately 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORHande Keskin Nurse

Acibadem University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026