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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Mother's voice, lullaby, preterm newborn, stress, sleep-wakefulness state

Eligibility Criteria

32 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Mother Voıce

    Lullably

    Control

    Arm Description

    Premature baby group with mother voıce application.

    Premature baby group with lullably application.

    Premature baby group with no application

    Outcomes

    Primary Outcome Measures

    Newborn Stress Evaluation Form (NSEF)
    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

    Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)
    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.

    Full Information

    First Posted
    April 5, 2021
    Last Updated
    May 10, 2021
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04886648
    Brief Title
    THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
    Official Title
    THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    March 28, 2014 (Actual)
    Study Completion Date
    April 14, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth
    Keywords
    Mother's voice, lullaby, preterm newborn, stress, sleep-wakefulness state

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study will be conducted in a randomized controlled manner.
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mother Voıce
    Arm Type
    Experimental
    Arm Description
    Premature baby group with mother voıce application.
    Arm Title
    Lullably
    Arm Type
    Experimental
    Arm Description
    Premature baby group with lullably application.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Premature baby group with no application
    Intervention Type
    Behavioral
    Intervention Name(s)
    Music Therapy
    Primary Outcome Measure Information:
    Title
    Newborn Stress Evaluation Form (NSEF)
    Description
    NSEF, there is no stress indicator '0', mild stress indicators' 1 ', moderate stress indicators' 2', and severe stress indicators'. It is scored as 3.
    Time Frame
    NSEF was measured on days 1 through 5, which had a 5-day application period.
    Secondary Outcome Measure Information:
    Title
    Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)
    Description
    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.
    Time Frame
    NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.
    Other Pre-specified Outcome Measures:
    Title
    Heart Rate
    Description
    During the study heart rate was recorded with the help of a pulsioxymeter.
    Time Frame
    Heart rate was measured on days 1 through 5, which had a 5-day application period.
    Title
    Respiratory Rate
    Description
    During the study, the number of respiration of preterm newborns was counted.
    Time Frame
    Respiratory rate was measured on days 1 through 5, which had a 5-day application period.
    Title
    Oxygen Saturation
    Description
    During the study, oxygen saturation was recorded with the help of a pulsioxymeter.
    Time Frame
    Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    DİLEK ERYÜRÜK
    Organizational Affiliation
    Study Principal Investigator
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Personal data will not be shared because it was promised in the study when consent was obtained from the participants.
    Citations:
    PubMed Identifier
    30826725
    Citation
    Robertson AM, Detmer MR. The Effects of Contingent Lullaby Music on Parent-Infant Interaction and Amount of Infant Crying in the First Six Weeks of Life. J Pediatr Nurs. 2019 May-Jun;46:33-38. doi: 10.1016/j.pedn.2019.02.025. Epub 2019 Feb 28.
    Results Reference
    result
    PubMed Identifier
    24092866
    Citation
    Peng NH, Chen LL, Li TC, Smith M, Chang YS, Huang LC. The effect of positioning on preterm infants' sleep-wake states and stress behaviours during exposure to environmental stressors. J Child Health Care. 2014 Dec;18(4):314-25. doi: 10.1177/1367493513496665. Epub 2013 Oct 3.
    Results Reference
    result
    PubMed Identifier
    23068310
    Citation
    Liaw JJ, Yang L, Lee CM, Fan HC, Chang YC, Cheng LP. Effects of combined use of non-nutritive sucking, oral sucrose, and facilitated tucking on infant behavioural states across heel-stick procedures: a prospective, randomised controlled trial. Int J Nurs Stud. 2013 Jul;50(7):883-94. doi: 10.1016/j.ijnurstu.2012.08.021. Epub 2012 Oct 12.
    Results Reference
    result
    PubMed Identifier
    23890458
    Citation
    Alipour Z, Eskandari N, Ahmari Tehran H, Eshagh Hossaini SK, Sangi S. Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial. Complement Ther Clin Pract. 2013 Aug;19(3):128-32. doi: 10.1016/j.ctcp.2013.02.007. Epub 2013 May 9.
    Results Reference
    result
    PubMed Identifier
    19757875
    Citation
    Keith DR, Russell K, Weaver BS. The effects of music listening on inconsolable crying in premature infants. J Music Ther. 2009 Fall;46(3):191-203. doi: 10.1093/jmt/46.3.191.
    Results Reference
    result

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

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