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

May 10, 2021 updated by: Dilek Deri̇nce Eryuruk, TC Erciyes University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

Premature babies who do not meet the inclusion criteria.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mother Voıce
Premature baby group with mother voıce application.
Behavioral: Music Therapy
Experimental: Lullably
Premature baby group with lullably application.
Behavioral: Music Therapy
No Intervention: Control
Premature baby group with no application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn Stress Evaluation Form (NSEF)
Time Frame: NSEF was measured on days 1 through 5, which had a 5-day application period.
NSEF, there is no stress indicator '0', mild stress indicators' 1 ', moderate stress indicators' 2', and severe stress indicators'. It is scored as 3.
NSEF was measured on days 1 through 5, which had a 5-day application period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)
Time Frame: NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.
The evaluation of the newborn status was carried out under the main headings of sleep and waking behaviors. Sleep behavior; deep sleep, light sleep and drowsy. Waking behavior is grouped under the headings of awake (extremely awake and eyelids awake), active awake and crying. As a result of the evaluation, it was decided that the behaviors of the newborn were in an organized or disorganized range, and the form was marked and scoring was created for the conditions starting from the deep sleep state to disorganized crying. In the evaluation of the data; The interpretation was made according to the state score of the newborn. It was interpreted that as the YUUDF score decreased, the sleep state of the newborns increased, and as the YUUDF score increased, the wakefulness and crying status of the newborns increased.
NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Heart rate was measured on days 1 through 5, which had a 5-day application period.
During the study heart rate was recorded with the help of a pulsioxymeter.
Heart rate was measured on days 1 through 5, which had a 5-day application period.
Respiratory Rate
Time Frame: Respiratory rate was measured on days 1 through 5, which had a 5-day application period.
During the study, the number of respiration of preterm newborns was counted.
Respiratory rate was measured on days 1 through 5, which had a 5-day application period.
Oxygen Saturation
Time Frame: Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.
During the study, oxygen saturation was recorded with the help of a pulsioxymeter.
Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: DİLEK ERYÜRÜK, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

March 28, 2014

Study Completion (Actual)

April 14, 2016

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eryuruk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal data will not be shared because it was promised in the study when consent was obtained from the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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