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Clinical Trials/NCT04886648
NCT04886648
Completed
N/A

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

TC Erciyes University0 sites90 target enrollmentMarch 1, 2014
ConditionsPreterm Birth

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
TC Erciyes University
Enrollment
90
Primary Endpoint
Newborn Stress Evaluation Form (NSEF)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
April 14, 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dilek Deri̇nce Eryuruk

Principal Investigator

TC Erciyes University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)(NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.)

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