The Effects of the Maternal Voice Combined With Lullaby to Reduce the Heel Puncture Pain in Preterm Infant

NCT05043337 | Completed DMC

• 1 other identifier: Y_110_0206
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, 183,254 newborns were born in 2018, with preterm births accounting for about 8-10%. The preterm infant required frequent medical treatment from birth to hospital discharge, which is accompanied by a painful process that can cause unstable vital signs in the short term and may affect their biological and psychological development in the long term. Music therapy is a non-invasive and easily accessible intervention, can be used to reduce the discomfort of painful stimulation during hospitalization of preterm infants. Music therapies in this text are the mother's voice and lullabies.

Conditions

Pain

Keywords

premature; maternal voice; lullaby; heel punture; neonatal pain

Outcome Measures

Primary Outcomes (4)

• Heart rate

  Using the German-made PHILIPS IntelliVue MP40 Dräger Julian physiological index monitor, including monitoring Heart Rate (HR).

  Change from Baseline Heart rate at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure

• Respiratory rate

  Using the German-made PHILIPS IntelliVue MP40 Dräger Julian physiological index monitor, including monitoring Respiratory rate (RR).

  Change from Baseline Respiratory rate at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure

• Oxygen Saturation

  Using the German-made PHILIPS IntelliVue MP40 Dräger Julian physiological index monitor, including monitoring Saturation of Peripheral Oxygen (SPO2).

  Change from Baseline Saturation of Peripheral Oxygen at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure

• Respond of Pain

  Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs, and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

  Change from Baseline Pain at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure

Study Arms (4)

Maternal voice

EXPERIMENTAL

Recording the maternal voice in reading children's books, and recorded the sound for 13 minutes. When the premature infants undergoing heel lance procedure, the experimental group was explored maternal voice, which starts from 3 minutes before the procedure and ends ten minutes after the heel puncture.

Behavioral: Maternal voice

Lullaby

EXPERIMENTAL

The Brahms Lullaby recordings are compiled for 13 minutes. When the premature infants undergoing heel lance procedure, the experimental group was explored Brahms Lullaby, which starts from 3 minutes before the procedure and ends ten minutes after the heel puncture.

Behavioral: Lullaby

Maternal voice combined with lullaby

EXPERIMENTAL

Recording the maternal voice in reading children's books and giving mother listening to the lullaby at the same time, and recorded the sound for 13 minutes. When the premature infants undergoing heel lance procedure, the experimental group was explored Maternal voice combined with Brahms lullaby, which starts from 3 minutes before the procedure and ends ten minutes after the heel puncture.

Behavioral: Maternal voice combined with lullaby

Control group

NO INTERVENTION

When the premature infants undergoing heel lance procedure , the control group was under routine care . Measuring with the Respiration , heart rate , oxygen saturation , and neonatal infant pain scale (NIPS ) were recorded 3 minutes before , during , 1st , 3rd , and 10th minutes after the heel lance puncture .

Interventions

Maternal voice BEHAVIORAL

The recordings were made in a quiet and separate consultation room. For infants in the "maternal voice group," mothers were recorded what they wanted to say to their baby and read an independently published children's book, "Xiao Qi's yellow persimmon" which describes how mothers with premature babies care for their infants. After reviewing the quality of the recordings, the maternal voice recordings were edited for 13 minutes using a sound organizer. Respiration, heart rate, oxygen saturation, and Neonatal Infant Pain Scale (NIPS) were measured and recorded 3 minutes before, during, 1 minute, 3 minutes, and 10 minutes after the puncture.

Maternal voice

Lullaby BEHAVIORAL

The Brahms Lullaby recordings are compiled for 13 minutes. Measuring with the Respiration, heart rate, oxygen saturation, and neonatal infant pain scale (NIPS ) were recorded 3 minutes before, during, 1st, 3rd, and 10th minutes after the heel lance puncture.

Lullaby

Maternal voice combined with lullaby BEHAVIORAL

The recordings were made in a quiet and separate consultation room. For infants in the " Maternal voice combined with lullaby group, " mothers were recorded what they wanted to say to their baby and read an independently published children's book-"Xiao Qi's yellow persimmon ", and giving mother listening to the Brahms Lullaby at the same time, the maternal voice recordings were edited for 13 minutes using a sound organizer. Measuring with the Respiration, heart rate, oxygen saturation, and neonatal infant pain scale (NIPS ) were recorded 3 minutes before, during, 1st, 3rd, and 10th minutes after the heel lance puncture.

Maternal voice combined with lullaby

Eligibility Criteria

• Age: 2 Days - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies born alive before 37 weeks of pregnancy.
• Infants who were required to receive heel lance procedure every 8 hours after physicians' diagnoses.
• Those who can record the mother's voice and whose mother can read Chinese.

You may not qualify if:

• Abnormal ear appearance, chromosomal abnormalities, congenital or acquired infections.
• Postnatal patients whose mothers are not in the postnatal ward, e.g., those who need to be admitted to the intensive care unit due to their medical condition.
• Patients used high-frequency oscillatory ventilators, because the high-frequency oscillatory ventilator gives 600 oscillatory breaths per minute and it is not possible to evaluate whether the study subjects can effectively listen to the interventions given, so they were excluded.
• Mothers who were unable to complete the recording because of emotional ups and downs during the recording process.
• Mothers who smoked, drank alcohol or used illegal drugs during pregnancy.
• the patients was diagnosed with Asphyxia of the newborn at birth
• Painkillers used within 2 days of birth.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

Location

Related Publications (5)

• Filippa M, Panza C, Ferrari F, Frassoldati R, Kuhn P, Balduzzi S, D'Amico R. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017 Aug;106(8):1220-1229. doi: 10.1111/apa.13832. Epub 2017 Apr 19.

  PMID: 28378337 BACKGROUND

• Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.

  PMID: 28580602 BACKGROUND

• Polkki T, Korhonen A. The effectiveness of music on pain among preterm infants in the neonatal intensive care unit: a systematic review. JBI Libr Syst Rev. 2012;10(58):4600-4609. doi: 10.11124/jbisrir-2012-428.

  PMID: 27820525 BACKGROUND

• Jabraeili M, Sabet T, MustafaGharebaghi M, Asghari Jafarabadi M, Arshadi M. The Effect of Recorded Mum's Lullaby and Brahm's Lullaby on Oxygen Saturation in Preterm Infants: a Randomized Double-Blind Clinical Trial. J Caring Sci. 2016 Mar 1;5(1):85-93. doi: 10.15171/jcs.2016.009. eCollection 2016 Mar.

  PMID: 26989669 BACKGROUND

• Uematsu H, Sobue I. Erratum: Effect of music (Brahms lullaby) and non-nutritive sucking on heel lance in preterm infants: A randomized controlled crossover trial. Paediatr Child Health. 2019 Feb;24(1):63. doi: 10.1093/pch/pxy163. Epub 2018 Dec 14.

  PMID: 30793710 BACKGROUND

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: October 31, 2021
• Primary Completion: September 30, 2022
• Study Completion: February 6, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)