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

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
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
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
Learn more about this trial
THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
We'll reach out to this number within 24 hrs