NCT05043337

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 2 Days – 2 Days
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Maternal voice	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.
BEHAVIORAL	Lullaby	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.
BEHAVIORAL	Maternal voice combined with lullaby	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.

Timeline

• Start date: 2021-10-31
• Primary completion: 2022-09-30
• Completion: 2023-02-06
• First posted: 2021-09-14
• Last updated: 2023-11-24

Locations

1 site across 1 country: Taiwan