Comforf, Procedural (During Newborn Care İn Newborn's)NCT04942587
The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's
A study testing LISTENING TO THE RECORDINGS SAYING BY PARENTS in people with Comforf, Procedural (During Newborn Care İn Newborn's) and Physiological Parameters During Newborn Care İn Newborn's, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Comforf, Procedural (During Newborn Care İn Newborn's), Physiological Parameters During Newborn Care İn Newborn's
- What is being tested?
- LISTENING TO THE RECORDINGS SAYING BY PARENTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 20 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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),
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- Absence of intracranial bleeding,
- No sedative, opioid and anticonvulsant drugs were given before/during the study,
- Parents' consent to participate in the study,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Kocaeli Hospital
Kocaeli, Izmit, 41000
About this study
Official title: 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 .
- Conditions
- Comforf, Procedural (During Newborn Care İn Newborn's), Physiological Parameters During Newborn Care İn Newborn's
- Being tested
- LISTENING TO THE RECORDINGS SAYING BY PARENTS
- Keywords
- Mother's voice, Father's voice, Lullaby, Comfort, Physiological Parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISTENING TO THE RECORDINGS SAYING BY PARENTSBehavioural
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| mother's voices | Experimental | 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. Receives: Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS |
| father's voices group | Experimental | 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. Receives: Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The effect of lullaby records sung by the parent's during newborn care on newborns comfort in newborn intensive care unit.
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).
Measured: 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.
heart beat- bpm
Measured: 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.
respiration rate
Measured: 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.
ects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing SpO2
Measured: 35 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Apr 2018
- Primary completion5 Apr 2018
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comforf, Procedural (During Newborn Care İn Newborn's)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Akyuz, Kocaeli University
- Investigators
- Duygu Akyüz, Principal investigator, binayduygu@gmail.comGülzade Uysal, Principal investigator, gülzadeuysal@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942587
- Sponsor's protocol ID
- KÜ GOKAEK 2018/90
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's And Physical Parameters In Newborn Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04942587
- Acronym / sponsor ID
- KÜ GOKAEK 2018/90
- Conditions
- Comforf, Procedural (During Newborn Care İn Newborn's), Physiological Parameters During Newborn Care İn Newborn's
- Keywords
- Mother's voice, Father's voice, Lullaby, Comfort, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mother's voices | Experimental | Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTSStandard 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. |
| father's voices group | Experimental | Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTSStandard 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LISTENING TO THE RECORDINGS SAYING BY PARENTSThe baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes. | Behavioural | father's voices group, mother's voices |
Primary outcome
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).
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Akyüz principal investigator
binayduygu@gmail.com
Gülzade Uysal principal investigator
gülzadeuysal@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LISTENING TO THE RECORDINGS SAYING BY PARENTS in people with Comforf, Procedural (During Newborn Care İn Newborn's) and Physiological Parameters During Newborn Care İn Newborn's, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.