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

NCT05520164 | Completed

• 1 other identifier: Saglik Bilimleri U
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Infant, Newborn, Disease

Keywords

Pain; Newborn; Non-Drug Pain Management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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 Group

EXPERIMENTAL

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

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 2 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Newborns whose heel blood cannot be taken at once

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Pendik District Health Directorate: collaborator

Study Sites (1)

Pendik Mehmet Oguz Family Health Center

Istanbul, 34668, Turkey (Türkiye)

Location

Related 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

MeSH Terms

Conditions

Pain; Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Sümeyye KOSE, Phd Student

  Pendik District Health Directorate

  PRINCIPAL INVESTIGATOR

• Besey OREN, Associate Prof

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The two separate clinicians conducting the assessment were masked to allow for impartiality.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized controlled trial.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: October 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)