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The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants

E

Ege University

Status

Completed

Conditions

Premature Infant
Premature Birth

Treatments

Other: MiniMuff
Other: RECORDED MOTHER'S VOICE
Other: White Noise

Study type

Interventional

Funder types

Other

Identifiers

NCT04067206
17HEF001

Details and patient eligibility

About

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.

Full 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.

Enrollment

256 patients

Sex

All

Ages

31 to 36 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Born by cesarean section
  • Non-supported by a mechanical ventilator or NCPAP
  • Started to feed
  • Within the first 10 days of postnatal

Exclusion criteria

  • Had a major congenital malformation,
  • Apgar score was less than 5 in the 1st-minute and less than 7 in the 5th-minute
  • Received a sedative, muscle relaxant, corticosteroid, or analgesic therapy,
  • First blood sampling attempt was unsuccessful
  • MiniMuffs moved from their ears during the procedure
  • Mothers who had problems recording their voice.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

256 participants in 4 patient groups

Recorded mothers' voice group.
Experimental group
Description:
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.
Treatment:
Other: RECORDED MOTHER'S VOICE
White Noise
Experimental group
Description:
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.
Treatment:
Other: White Noise
MiniMuffs
Experimental group
Description:
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.
Treatment:
Other: MiniMuff
Control Group
No Intervention group
Description:
The control group who were administered standard care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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