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

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT04886648
Collaborator
(none)
90
3
25.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will be conducted in a randomized controlled manner.The study will be conducted in a randomized controlled manner.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Video footage in the study was made by three experts. Experts blindly evaluated the groups to which the videos they evaluated belonged to.
Primary Purpose:
Prevention
Official Title:
THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Mar 28, 2014
Actual Study Completion Date :
Apr 14, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Newborn Stress Evaluation Form (NSEF) [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 Outcome Measures

  1. Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF) [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 Outcome Measures

  1. Heart Rate [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
32 Months to 36 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Principal Investigator: DİLEK ERYÜRÜK, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dilek Deri̇nce Eryuruk, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT04886648
Other Study ID Numbers:
  • Eryuruk
First Posted:
May 14, 2021
Last Update Posted:
May 14, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dilek Deri̇nce Eryuruk, Principal Investigator, TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2021