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NCT Number: NCT06607575

The Effect of Warming and Vibration Applications on Pain in Newborns

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem University, Istanbul, Ata, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Control Group

Other
  • The procedure for heel blood collection will be performed.
  • Pain assessment will be performed with the N-PASS scale during and after the procedure.

Warming

Other
  • 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.
  • The procedure for heel blood collection will be performed.
  • Pain assessment will be performed with the N-PASS scale during and after the procedure.

Vibration

Other
  • 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.
  • The procedure for heel blood collection will be performed.
  • Pain assessment will be performed with the N-PASS scale during and after the procedure.

Warming and vibration

Other
  • 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.
  • The procedure for heel blood collection will be performed.
  • Pain assessment will be performed with the N-PASS scale during and after the procedure.

Primary outcomes

  1. Change in level of pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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