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

NCT04067206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2020-01-27

No results posted yet for this study

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.

Conditions

  • Premature Birth
  • Premature Infant

Interventions

OTHER

RECORDED MOTHER'S VOICE

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.

OTHER

White Noise

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.

OTHER

MiniMuff

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Zümrüt Başbakkal, Professor · Ege University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-10
Primary Completion
2018-06-21
Completion
2019-04-13

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT04067206 on ClinicalTrials.gov