The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
Condition: Premature Birth; Premature Infant
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study investigated the effects of three interventions -recorded mother's voice, white
      noise, and MiniMuffs, muffs used to attenuate environmental sounds- applied during a heel
      lance on pain and comfort in premature infants. This randomized controlled research was
      conducted in a state hospital tertiary-level neonatal intensive care unit. Sixty-four
      premature neonates with a gestational age of 31-36 who were stable, didn't receive mechanic
      ventilation and has been started feeding participated. The infants were randomly assigned to
      four groups: i) white noise , ii) recorded mother's voice, iii) MiniMuffs (earmuff), and iv)
      control. Five minutes before the procedure the white noise and mother's voice played and
      MiniMuffs placed on babies' ears. The heel lance procedure was recorded on a camera. The
      camera recordings were evaluated for premature infants' pain and comfort according to the
      Neonatal Infant Pain Scale (NIPS) and the Comfort behavior (COMFORTneo) scale.
    

Detailed description: 
      Auditory interventions are commonly used during procedural analgesic administration in
      premature neonates. This study investigated the effects of three interventions -recorded
      mother's voice, white noise, and MiniMuffs, muffs used to attenuate environmental sounds-
      applied during a heel lance on pain and comfort in premature infants. This experimental study
      is a randomized controlled research. The data for the research were collected between
      September 2017 - April 2019. The sample comprised 64 premature infants with gestational ages
      of 31-36 weeks, who had been hospitalized at the Neonatal Intensive Cate Units (NICU). All
      infants in the study were in their first postnatal week. The study routine included a heel
      lance procedure to determine the level of bilirubin and hematocrit. The heel lance was
      performed with a lancet and the blood was transferred to the hematocrit pipette. All heel
      lances were conducted by the same nurse. Power analysis was conducted to determine the number
      of samples needed. Predicting that the NIPS score would decrease by 30-35% and decrease from
      6 to 4-4.5 with 0.05 error and 80% power, the intervention groups yielded 64 infants divided
      into four groups of 16 as the target sample number. 80 infants included in the study, taking
      into account the loss of sample. Sixteen infants were excluded from the study. Sixty-four
      premature infants submitted for heel lance were evaluated.The randomization list was prepared
      by a third person using R version 3.1.3 package program and considering the gender factor.
      The list was concealed from the researcher and the family of the baby, and it was given to
      the researcher only during the procedure. The infants were randomly assigned to four groups.
      The infants were randomly assigned to four groups: i) white noise , ii) recorded mother's
      voice, iii) MiniMuffs, and iv) control. Five minutes before the procedure the white noise and
      mother's voice played and MiniMuffs placed on babies' ears. Heel lance procedures were
      recorded with a camera. Camera recording started before the procedure and continued until the
      baby stopped crying. The videos evaluated independently by two scientists (observers) who
      were specialists in neonatal services and pain. Observers evaluated infants' comfort, pain,
      and distress based on NIPS and COMFORTneo. In order to evaluate the agreement between the
      observers for the total scores of NIPS and COMFORTneo, pain estimation, and distress
      estimation, intraclass correlation coefficient were determined.
    

Intervention name(s): RECORDED MOTHER'S VOICE; White Noise; MiniMuff
Intervention type(s): Other; Other; Other
Intervention description(s): The mothers of the babies were given voice recorders and asked to record their voice in a comfortable room saying whatever they wanted to their baby. Each mother recorded her voice for 3-5 minutes. The voice recorder was placed at the baby's foot five minutes before the procedure and then played to the baby during the procedure.The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.; The white noise was started five minutes before the heel lance and was played to the baby during the procedure. Dr. Harvery Karp's "The Happiest Baby," which consists of only intrauterine sounds, was used. The speakers were placed at a distance of about 30 cm from the foot of the neonate. The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.; MiniMuffs placed on their ears five minutes before the procedure to reduce the environmental noise. Latus MiniMuffs - Neonatal Noise Attenuators have been developed for newborns and premature babies. MiniMuffs protect the sensitive ears of the premature and provide a safe environment for healthy development.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This experimental study is a randomized controlled research. The infants were randomly assigned to four groups. Three interventions, each alone and in combination, are evaluated in parallel against a control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Premature; Pain; Comfort; Auditory Interventions