- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942587
The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's
June 25, 2021 updated by: Duygu Akyuz, Kocaeli University
The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's And Physical Parameters In Newborn Intensive Care Unit
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
The data was evaluated in SPSS 21.0 program with convenient statistical methods.İt is detected that heart rate, respiration rateand comfort behiavour scores of the newborns who listen to lullaby in the mother's voice are low compared to the newborns listening to lullaby in the father's voice and those in the control group .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Izmit
-
Kocaeli, Izmit, Turkey, 41000
- University of Kocaeli Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 8 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Premature babies at 30-37 weeks of gestation,
- There is no congenital anomaly affecting respiration and spontaneous respiration,
- No intubation,
- Absence of congenital or acquired malfarmation related to hearing,
- Absence of hyperbilirubinemia requiring exchange transfusion,
- Absence of intrauterine infection (rubella, syphilis, toxoplasma),
- Absence of intracranial bleeding,
- No sedative, opioid and anticonvulsant drugs were given before/during the study,
- Parents' consent to participate in the study,
Exclusion Criteria:
- Having a diagnosis of asphyxia,
- Congenital hearing problems in family members,
- Intubating the baby after starting the research,
- Parents have a speech impediment,
- Parents have psychological problems,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mother's voices
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.
The baby was made listen to the lullaby recorded in the voice of mother's starting with, during and after the care for 10 minutes.
Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
|
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
|
Experimental: father's voices group
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.
The baby was made listen to the lullaby recorded in the voice of father's starting with, during and after the care for 10 minutes.
Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
|
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
|
No Intervention: control group
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of lullaby records sung by the parent's during newborn care on newborns comfort in newborn intensive care unit.
Time Frame: 35 minute
|
Newborn comfort behavior scale was used for determinain Comfort behiavour scores in this research.
Scale got 0 to 35 points (0 (Good) to 35 (Bad).
|
35 minute
|
The effect of lullaby records sung by the parent's during newborn care on newborns on the heart beat in newborn intensive care unit.
Time Frame: 35 minute
|
heart beat- bpm
|
35 minute
|
The effect of lullaby records sung by the parent's during newborn care on newborns on the respiration rate in newborn intensive care unit.
Time Frame: 35 minute
|
respiration rate
|
35 minute
|
The effect of lullaby records sung by the parent's during newborn care on newborns on the SpO2 in newborn intensive care unit.
Time Frame: 35 minute
|
ects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing SpO2
|
35 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duygu Akyüz, binayduygu@gmail.com
- Principal Investigator: Gülzade Uysal, gülzadeuysal@gmail.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
April 5, 2018
Study Completion (Actual)
January 20, 2019
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 23, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 29, 2021
Last Update Submitted That Met QC Criteria
June 25, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KÜ GOKAEK 2018/90
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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