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Completed

NCT Number: NCT05520164

Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection

This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

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Key information

Conditions

Pain Disease Infant, Newborn, Disease Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pendik Mehmet Oguz Family Health Center

Istanbul, 34668, Turkey (Türkiye)

About this study

The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gestational age of 38-41 weeks,
  • Chronological age of 2-28 days,
  • Without any physical, metabolic or genetic disease,
  • Newborns who did not use any analgesic drugs before the procedure

Exclusion criteria

  • Newborns whose heel blood cannot be taken at once

Treatment and study plan

Listening the maternal heart sound during the invasive interventions

Other

Heart sounds of the newborns' own mothers were recorded on the voice recorder with the help of a hand doppler device. This sound was listened by the newborns in the experimental group during the heel blood procedure.

Primary outcomes

  1. The Newborn Infant Pain Scale (NIPS)

    Time frame: 15 minutes

    The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Pendik District Health Directorate

Registry information

Official study title

Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2022
Registry last updated
Sep 2, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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