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Completed

NCT Number: NCT04886648

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

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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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

32 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Music Therapy

Behavioral

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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