Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding
Condition: Infant, Extremely Premature; Voice; Pain; Bonding
MeSH terms: Premature Birth
Study type: Interventional

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).
    

Detailed description: 
      This study is a quantitative study, using Experimental Research Design, using G*Power 3.1 to
      estimate the number of samples, the sample size is 62. There aren't rule out the possibility
      of congenital hearing loss. According to the literature, the prevalence of deafness in
      premature or low-weight newborns is about 1-2%. Therefore, the number of samples will
      increase by 2 according to the prevalence of deafness. After the completion of the case, the
      hearing screening of the subjects will be continuously tracked to avoid the final loss of
      samples. Therefore, the total number of cases is 64. In this study, the allocation
      concealment principle was applied. Before the distribution, the main caregivers and
      researchers did not know the distribution rules and the distribution results. The sampling
      method of randomized control trial stratified block randomization was adopted. According to
      the past clinical birth rate, the number of weeks of pregnancy was less than 31+6 weeks. The
      proportion of newborns born from 32 weeks to 36+6 weeks of gestational weeks is about 1:2,
      respectively. Finally, the experimental group and the control group were randomly assigned in
      this way. There are 20 infants in less than 31+6 weeks group, 44 infants in more than 31+6
      weeks group.

      The process of receiving the case was the evening of the 4th day after the birth of the study
      subjects. The premature infants of the experimental group began to listen the maternal voice
      3 minutes before the heel lance procedure until the end of the blood collection for 13
      minutes, Heart rate (HR), respiratory rate (RR), oxygen saturation (%, OSPR), and pain which
      evaluated by Neonatal Infants Pain Scale (NIPS) were recorded 3 minutes before, during,and at
      the first and 10th minutes after heel lance procedure. The monitoring was continued for 3
      days.

      The study was conducted for three consecutive days from the fourth day after the birth of the
      subject. The three-day experimental group and the control group were recorded by the camera,
      uploaded to YouTube within 24 hours after recording, and the film was used for three
      consecutive days using a private link. Confirm that the mother has watched this video.and
      please ask the mother to fill out the mother-infant bonding questionnaire.
    

Intervention name(s): Maternal voice
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care