THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2016-04-14

Brief Summary

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The study was planned in a randomized controlled manner in order to evaluate the effect of mother's voice and lullaby on stress and sleep-wake situations of premature babies.

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Detailed Description

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Objective:This randomized controlled study was carried out to evaluate the effect of mother's voice and lullaby on preterm infants' stress and sleeping-waking states.

Study design:The study was carried out in a newborn unit in a public hospital in Turkey. In this study, 90 preterm newborn were divided into three groups equally as mother's voice (n=30), lullaby (n=30) and control groups (n=30). Data were obtained by Mother and Newborn Identification Form, Newborn Stress Evaluation Form (NSEF) and Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF). On the 1st, 3rd and 5th days of the study; Newborns' NSEF and NSWEF scores at pre-, post-study and on the fifth minutes were evaluated. Data were evaluated by using descriptive statistics, homogeneity tests, chi-square, intra-class correlation coefficent, two way of analysis on repeated measures, generalized linear model, pearson correlation analysis.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be conducted in a randomized controlled manner.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Video footage in the study was made by three experts. Experts blindly evaluated the groups to which the videos they evaluated belonged to.

Study Groups

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Mother Voıce

Premature baby group with mother voıce application.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

Lullably

Premature baby group with lullably application.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

Control

Premature baby group with no application

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 32 0/6 -36 6 weeks of gestation
* Not connected to respiratory support device
* No surgical intervention
* Not receiving medical treatment other than appropriate vitamin supplements and antibiotic treatments
* Does not have a congenital or acquired malformation related to hearing,
* Can tolerate enterally given food (no NEC, digestive system and chromosomal abnormalities)
* The mother is at least a primary school graduate
* Diabetic mother without a baby • SGA and no IUGR

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Minimum Eligible Age

32 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes