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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Infant, Newborn, Disease
• Intervention / Treatment: Other: Listening the maternal heart sound during the invasive interventions

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Pendik Mehmet Oguz Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Routine heel blood was taken from the control group. 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 watched and scored by two midwives who had training in the Neonatal Pain Scale.
Experimental: Experimental Group; 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.	Other: Listening the maternal heart sound during the invasive interventions; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Newborn Infant Pain Scale (NIPS)	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.	15 minutes

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Collaborators: Pendik District Health Directorate
• Investigators: Principal Investigator: Sümeyye KOSE, Phd Student, Pendik District Health Directorate; Study Director: Besey OREN, Associate Prof, Saglik Bilimleri Universitesi

Publications and helpful links

Helpful Links

• Effect of interactive distraction versus cutaneous stimulation for venipuncture pain relief in school age children.
• Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: a quasi-experimental study. Com
• Pain control with lavender oil in premature infants: a double-blind randomized controlled study. The Journal of Alternative and Complementary Medicine, 27(2), 136-141.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Newborn; Non-Drug Pain Management
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: Saglik Bilimleri U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No