The Effect of Warming and Vibration Applications on Pain in Newborns

Acibadem University

Status: Completed

Conditions: Pain

Treatments: Other: Warming and vibration; Other: Warming; Other: Vibration; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06607575

ATADEK 2023-10/403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Control group

Other group

Description:

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.

Treatment:

Other: Control group

Experimental group (warming)

Experimental group

Description:

Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group.

Treatment:

Other: Warming

Experimental group (vibration)

Experimental group

Description:

Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group.

Treatment:

Other: Vibration

Experimental group (warming and vibration)

Experimental group

Description:

Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group.

Treatment:

Other: Warming and vibration