Pain, Procedural (During Sternum Dressing on Infants)NCT04894487
The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing
A study testing THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY in people with Pain, Procedural (During Sternum Dressing on Infants) and Physiological Parameters During Sternum Dressing in Babies, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Pain, Procedural (During Sternum Dressing on Infants), Physiological Parameters During Sternum Dressing in Babies
- What is being tested?
- THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2020to 28 Feb 2021
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being 1-12 months
- Being volunteer for research
- Operated for Congenital Heart Disease
- Got Sternum incision
- No other chronic illness
- No similar surgical experiment before
Show all 10Show fewer
- No visual impairment
- No hearing impairment
- No mental or neurological impairment
- Hospitalization experience
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit
Küçükçekmece, Istanbul, 34303
About this study
Official title: The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing
The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".
- Conditions
- Pain, Procedural (During Sternum Dressing on Infants), Physiological Parameters During Sternum Dressing in Babies
- Being tested
- THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
- Keywords
- Sternum Dressing, Infant, Brahms Lullaby, Baby Mobile, Pain, Physiological Parameters
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABYBehavioural
Using of baby mobile and listening Brahms Lullaby during sternum dressing process
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The babies have got sternum incision after the pediatric cardiac surgery. Experiment is about the dressing of the sternum incision. There is no extra intervention during sternum dressing at control group like routine of pediatric cardiovascular surgery intensive care clinic. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing. |
| THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP | Experimental | Baby mobile and Brahms Lullaby started before the 10 minutes of sternum dressing process and controlled permanence of the baby mobile and Brahms Lullaby during sternum dressing. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing. Receives: Behavioral: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Bad) to 10 (Good)).
Measured: 30 minutes
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
heart beat- bpm
Measured: 30 minutes
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
blood pressure- mmHg
Measured: 30 minutes
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
body temperature-- degrees centigrade
Measured: 30 minutes
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
SpO2
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start25 Aug 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, Procedural (During Sternum Dressing on Infants)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled two groups ( control group and experiment group)
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil KARAKAYA, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894487
- Sponsor's protocol ID
- 15761188
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karakaya K, Uysal G. The effect of the use of baby mobile accompanied by Brahms' lullaby on the physiological parameters and pain level of the baby during sternum dressing. J Pediatr Nurs. 2026 Jul-Aug;89:520-527. doi: 10.1016/j.pedn.2026.05.014. Epub 2026 May 26.
PubMed 42191409
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing
- ClinicalTrials.gov ID
- NCT04894487
- Acronym / sponsor ID
- 15761188
- Conditions
- Pain, Procedural (During Sternum Dressing on Infants), Physiological Parameters During Sternum Dressing in Babies
- Keywords
- Sternum Dressing, Infant, Brahms Lullaby, Baby Mobile, Pain, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 May 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.
The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled two groups ( control group and experiment group)
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The babies have got sternum incision after the pediatric cardiac surgery. Experiment is about the dressing of the sternum incision. There is no extra intervention during sternum dressing at control group like routine of pediatric cardiovascular surgery intensive care clinic. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing. |
| THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP | Experimental | Behavioral: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABYBaby mobile and Brahms Lullaby started before the 10 minutes of sternum dressing process and controlled permanence of the baby mobile and Brahms Lullaby during sternum dressing. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Being 1-12 months
- Being volunteer for research
- Operated for Congenital Heart Disease
- Got Sternum incision
- No other chronic illness
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABYUsing of baby mobile and listening Brahms Lullaby during sternum dressing process | Behavioural | THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP |
Primary outcome
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
Time frame: 30 minutes
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Bad) to 10 (Good)).
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
Time frame: 30 minutes
heart beat- bpm
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
Time frame: 30 minutes
blood pressure- mmHg
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
Time frame: 30 minutes
body temperature-- degrees centigrade
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
Time frame: 30 minutes
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 20 May 2021.
- Derived from this study: PubMed 42191409Karakaya K, Uysal G. The effect of the use of baby mobile accompanied by Brahms' lullaby on the physiological parameters and pain level of the baby during sternum dressing. J Pediatr Nurs. 2026 Jul-Aug;89:520-527. doi: 10.1016/j.pedn.2026.05.014. Epub 2026 May 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY in people with Pain, Procedural (During Sternum Dressing on Infants) and Physiological Parameters During Sternum Dressing in Babies, run by Okan 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 10 inclusion and 1 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 20 May 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 effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894487, which also lists 1 linked publication.
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 20 May 2021.