MedTrace Logo

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

NCT04158206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-11-08

No results posted yet for this study

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

Interventions

OTHER

Maternal voice

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.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2019-08-20
Completion
2019-10-16

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158206 on ClinicalTrials.gov