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

Not Applicable

Completed

• Conditions: Pain; Infant, Newborn, Disease
• Interventions: Other: Listening the maternal heart sound during the invasive interventions

• Registration Number: NCT05520164
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-03-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-29
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Listening the maternal heart sound during the invasive interventions	The newborns in the experimental group listened to the recorded heart sounds of their mothers for 1 minute before the heel blood procedure, during the procedure and for 1 minute after the procedure. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was monitored and scored by two midwives trained in the Neonatal Pain Scale.

Primary Outcome Measures

Name	Time	Method
The Newborn Infant Pain Scale (NIPS)	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.

Trial Locations

Locations (1)

Pendik Mehmet Oguz Family Health Center; 🇹🇷 Istanbul, Turkey