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PainNCT05043337

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

A study testing Maternal voice, Lullaby and Maternal voice combined with lullaby in people with Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 2 days
Conditions the study is for
Pain
What is being tested?
Maternal voice, Lullaby and Maternal voice combined with lullaby
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTaiwan
Study dates
31 Oct 2021to 6 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 2 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Yang Ming Chiao Tung University

    Taipei, 11221

Other trials in Taiwan

About this study

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.

Read the detailed description

This study was a quantitative study of a randomized controlled trial, designed by experimental research method, and followed the principle of Allocation Concealment to conduct a randomized assignment trial. Using G*Power 3.1 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size is 120.

The subjects were divided into four groups, all four groups were administered general routine care, three experimental groups, and one control group, and the experimental group was a repetitive segment of audio recording edited to 13 minutes. There were three interventions: group A maternal voice reading children's books, group B lullaby, group C maternal voice reading children's books combined with lullaby, and the control group was the routine care group without any audio intervention. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and pain response assessed using the Neonatal Infant Pain Scale (NIPS), were recorded 3 minutes before, during, 1st, 3rd, and 10 minutes after heel lance puncture.

Conditions
Pain
Being tested
Maternal voice, Lullaby, Maternal voice combined with lullaby
Keywords
premature, maternal voice, lullaby, heel punture, neonatal pain
Medical subject headings
Pain, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maternal voiceBehavioural

    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.

  • LullabyBehavioural

    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.

  • Maternal voice combined with lullabyBehavioural

    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.

Study groups in NCT05043337
Study groupRoleWhat they receive
Maternal voiceExperimentalRecording 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.
Receives: Behavioral: Maternal voice
LullabyExperimentalThe 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.
Receives: Behavioral: Lullaby
Maternal voice combined with lullabyExperimentalRecording 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.
Receives: Behavioral: Maternal voice combined with lullaby
Control groupNo interventionWhen 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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate

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

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

  2. Respiratory rate

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

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

  3. Oxygen Saturation

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

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2021
  2. Study start31 Oct 2021
  3. Primary completion30 Sep 2022
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043337
Sponsor's protocol ID
Y_110_0206
Status last verified
Nov 2023
First submitted
5 Sep 2021
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28378337

  • 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.

    PubMed 28580602

  • 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.

    PubMed 27820525

  • 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.

    PubMed 26989669

  • 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.

    PubMed 30793710

Questions about this trial

What is this clinical trial studying?

A study testing Maternal voice, Lullaby and Maternal voice combined with lullaby in people with Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate (time frame: Change from Baseline Heart rate at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05043337, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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