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
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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