Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding

NCT04158206 | Completed

• 1 other identifier: 1902160001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups. The intervention used in the experimental group involved an audio recording with repeated clips of the mother reading a children's book, edited to a duration of 13 minutes. The research commenced on the fourth day after the birth of the research subjects, in which the maternal voice recording was played to infants during heel lance procedure once a day for 3 consecutive days. The infants in the control group received general routine care during heel lance procedure. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and pain response assessed using the Neonatal Infants Pain Scale (NIPS), were recorded 3 minutes before, during, and at the first and 10th minute after heel lance procedure. From the fourth to the sixth day after birth, video recordings of the research process were made and sent to the mother for viewing. On the seventh day after birth, the effectiveness of mother-infant bonding was evaluated using the Mother-Infant Bonding Inventory (MIBI).

Conditions

Infant, Extremely Premature; Voice; Pain; Bonding

Outcome Measures

Primary Outcomes (4)

• Heart rate

  Using the German-made PHILIPS IntelliVue MP60 Dräger Julian physiological index monitor, including monitoring Heart Rate (HR), recorded every 12 seconds.

  Change from Baseline Heart rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure

• Respiratory rate

  Using the German-made PHILIPS IntelliVue MP60 Dräger Julian physiological index monitor, including monitoring Respiratory Rate (RR), recorded every 12 seconds.

  Change from Baseline Respiratory rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure

• Oxygen Saturation

  Using the German-made PHILIPS IntelliVue MP60 Dräger Julian physiological index monitor, including monitoring Saturation of Peripheral Oxygen (SPO2), recorded every 12 seconds.

  Change from Baseline Oxygen Saturation at 3 minutes before, during, and at the first 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 the first and 10th minute after heel lance procedure

Secondary Outcomes (1)

• Mother-Infant Bonding Inventory (MIBI)

  On the 7th day birth

Study Arms (2)

Maternal voice

EXPERIMENTAL

The mother's voice recordings are compiled for 13 minutes. When the premature infants undergoing heel lance procedure, the experimental group were explored maternal voice, which start from 3 minutes before the procedure, once a day and for three consecutive days.And then recorded the process by the camera, uploaded to YouTube within 24 hours and sent to their mother.

Other: Maternal voice

control group

NO INTERVENTION

When the premature infants undergoing heel lance procedure, the control group were under routine care.And then recorded the process by the camera for three consecutive days, uploaded to YouTube within 24 hours and sent to their mother.

Interventions

Maternal voice OTHER

Recording in the intensive care unit quiet and separate consultation room. For infants in the 'maternal voice group,' mothers were asked to tape what the mother wants to say to their babies and read of a child book from the independent publish, 'Xiao Qi's yellow persimmon' which talk about the mother who has a premature infants how to take caring of their baby. After reviewing the quality of the recording, the mother's voice recordings are compiled for 13 minutes with Sound Organizer. 2 , and the volume of the sound standard according to the American Academy of Pediatrics guidelines is 60 decibels in the incubator.

Maternal voice

Eligibility Criteria

• Age: 4 Days - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Babies born alive before 37 weeks of pregnancy 2.Infant was singlet 3.Infants who were required to receive heel lance procedure every 8 hours after physicians' diagnoses 4.Infants' primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

You may not qualify if:

• Infants with congenital anomaly, congenital or postnatal sepsis, or brain injury 2.Infants' mother smoked, drunk or illegally used drugs while she was pregnant

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

Location

Related Publications (4)

• Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10.

  PMID: 29535067 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

• 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

• Yu WC, Chiang MC, Lin KC, Chang CC, Lin KH, Chen CW. Effects of maternal voice on pain and mother-Infant bonding in premature infants in Taiwan: A randomized controlled trial. J Pediatr Nurs. 2022 Mar-Apr;63:e136-e142. doi: 10.1016/j.pedn.2021.09.022. Epub 2021 Sep 30.

  PMID: 34602338 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

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: October 18, 2019
• First Posted: November 8, 2019
• Study Start: March 20, 2019
• Primary Completion: August 20, 2019
• Study Completion: October 16, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)