Nutrition Disorder, InfantNCT05333575
Lullaby and Classic Music's Effect on Vital Findings and Comfort
A study testing Lullaby and Classic music in people with Nutrition Disorder, Infant and Music, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorder, Infant, Music, Preterm
- What is being tested?
- Lullaby and Classic music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Dec 2020to 4 Apr 2022
- 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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being at 28-34 weeks of gestation,
- Stability (in terms of cerebral oxygenation, pain and vital signs) during enrollment,
- Not having any additional diagnosis other than the diagnosis of prematurity,
- Indication of bolus feeding with an orogastric tube,
Who cannot join
- Congenital anomaly in the baby
- Diagnosed hearing impairment in the baby
- Having a history of an invasive procedure (such as a surgical operation) that will disrupt the baby's long-term comfort and cause pain
- The baby is receiving oxygen therapy or the baby is on mechanical ventilation
- Any history of disease affecting cerebral oxygenation (such as intraventricular hemorrhage, neonatal convulsions).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University
Konya, 42100
Sibel Kucukoglu
Konya, 42100
About this study
Official title: The Effect of Lullaby and Classic Music to Prematures During Orogastric Tub Feeding on the Baby's Cerebral Oxygenization, Vital Findings and Comfort
In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.
Read the detailed description
In the literature, there are many studies on prematurity pain and its relief. Although the vital signs and comfort levels of infants were examined in many applications for infants hospitalized in the neonatal intensive care unit, no study was found in which the cerebral oxygenation levels of infants were evaluated by NIRS by listening to lullabies and classical music to premature infants. There is no study in the literature examining cerebral oxygenation, vital signs and comfort parameters together during orogastric tube feeding, which is frequently used in preterm infants. For this reason, in this study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. It is thought that the study will present new data to the literature and will lead many researches.
- Conditions
- Nutrition Disorder, Infant, Music, Preterm, Vital Signs
- Being tested
- Lullaby, Classic music
- Keywords
- preterm babies, cerebral oxygenation, lullabies, classical music
- Medical subject headings
- Infant Nutrition Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LullabyBehavioural
The mothers in this group were asked to sing a lullaby while their babies were fed with an orogastric tube. Mothers were released on lullabies. They were encouraged to sing the lullaby they knew or loved the most. The mother was given a sound decibel meter. Mothers were asked to do an application before going to the baby. It was taught that the number of sound decibels should not exceed 40 decibels while singing a lullaby. Later, the mother was taken to the baby's incubator at feeding time. She was seated in a chair. The working status of the decibel meter was checked and given to the mother. When the feeding started, the mother started singing lullabies and continued to sing until the feeding was finished. Attention was paid to aseptic techniques during all procedures. A single mother was asked to sing a lullaby at each feeding, and the baby of the mother who sang only a lullaby was included in the study.
Classic musicBehavioural
The babies in this group were given classical music recitals during feeding. The classical music piece Mozart-Baby Smart was preferred because it was seen to be used in the literature (Keidar 2014). Mozart-Baby Smart was loaded into the music player by the researcher before the feeding process. Before feeding, the decibel meter was disinfected by surface disinfectant and placed on sterile sponge in an incubator 10 cm away from the baby's head. The music player was turned on, not exceeding 40 decibels, by adjusting the decibel meter at the time of starting the feeding, and classical music was continued during the feeding. When the feeding was finished, the music player was turned off and the incubator was taken out. Attention was paid to acetic techniques during all procedures. Ambient sounds were tried to be controlled as much as possible so that the baby would not be affected by different sounds when listening to classical music.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Lullaby | Experimental | The mothers in this group sang lullabies to their babies next to the incubator during feeding. Receives: Behavioral: Lullaby |
| Experimental Group: Classic Music | Experimental | Babies in this group were listened to classical music during feeding. Receives: Behavioral: Classic music |
| Control Group | No intervention | Premature newborns in the control group were fed according to the routine of the clinic and no intervention was performed other than routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Information Form
This form was developed by the researcher using the literature (Loewy et al 2013, Caparros-Gonzalez et al 2018, Azarmnejad et al 2015, Alipour et al 2013). The form was composed of questions including introductory information about the baby, gestational age, postnatal age, gender, birth weight (gr), weight on the day of the intervention, type of delivery, 1st and 5th min apgar score.
Measured: First measurement - Before intervention
Regional brain oxygen saturation (rSO2) levels
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's rSO2 levels were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: First measurement - one minute before the baby is fed
Heart rate (minute)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: First measurement - one minute before the baby is fed
Oxygen saturation (%SpO2)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: First measurement - one minute before the baby is fed
Body temperature (°C)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: First measurement - one minute before the baby is fed
Respiratory rate (min)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: First measurement - one minute before the baby is fed
COMFORTneo Scale
The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Measured: First measurement - one minute before the baby is fed
Secondary outcomes (6)
Regional brain oxygen saturation (rSO2) levels
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: Second measurement - immediately after feeding
Heart rate (minute)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: Second measurement - immediately after feeding
Oxygen saturation (%SpO2)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: Second measurement - immediately after feeding
Body temperature (°C)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: Second measurement - immediately after feeding
Respiratory rate (min)
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Measured: Second measurement - immediately after feeding
COMFORTneo Scale
The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Measured: Second measurement - immediately after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start2 Dec 2020
- Primary completion15 Dec 2021
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition Disorder, InfantStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Research 28-34 preterm babies with gestational age hospitalized in the 2nd and 3rd level intensive care unit of Selcuk University Medical Faculty Hospital in Konya, Turkey. As a result of the power analysis, it was determined that the inclusion of 45 preterm infants in the study would provide sufficient sample size based on the two-sided hypothesis, 1.392 effect size, 0.05 margin of error and 0.95 power. Since the study period coincided with a period of uncertainties such as the Covid 19 pandemic, it was foreseen that there may be a loss in the number of babies included in the groups, and the sample number was increased by 10%, and the study was completed with a total of 51 premature babies (maternal voice group: 17, control group 17, classical music group 17).Babies of mothers who agreed to participate in the study were randomly assigned to the experimental and control groups. Simple randomization method was used in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, PhD, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333575
- Sponsor's protocol ID
- SelcukUniversity
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Keidar HR, Mandel D, Mimouni FB, Lubetzky R. Bach music in preterm infants: no 'Mozart effect' on resting energy expenditure. J Perinatol. 2014 Feb;34(2):153-5. doi: 10.1038/jp.2013.138. Epub 2013 Nov 14.
PubMed 24232665Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
PubMed 23589814Caparros-Gonzalez RA, de la Torre-Luque A, Diaz-Piedra C, Vico FJ, Buela-Casal G. Listening to Relaxing Music Improves Physiological Responses in Premature Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2018 Feb;18(1):58-69. doi: 10.1097/ANC.0000000000000448.
PubMed 29045255Azarmnejad E, Sarhangi F, Javadi M, Rejeh N. The Effect of Mother's Voice on Arterial Blood Sampling Induced Pain in Neonates Hospitalized in Neonate Intensive Care Unit. Glob J Health Sci. 2015 Apr 19;7(6):198-204. doi: 10.5539/gjhs.v7n6p198.
PubMed 26153174Alipour 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.
PubMed 23890458van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
PubMed 19692803Kahraman A, Başbakkal Z, Yalaz M, 2014. Yenidoğan Konfor Davranış Ölçeği'nin Türkçe geçerlik ve güvenirliği. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi, 1, 2, 1-11.
Bagli E, Kucukoglu S, Soylu H. The Effect of Lullabies and Classical Music on Preterm Neonates' Cerebral Oxygenation, Vital Signs, and Comfort During Orogastric Tube Feeding: A Randomized Controlled Trial. Biol Res Nurs. 2024 Apr;26(2):181-191. doi: 10.1177/10998004231202404. Epub 2023 Sep 22.
PubMed 37737114
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lullaby and Classic Music to Prematures During Orogastric Tub Feeding on the Baby's Cerebral Oxygenization, Vital Findings and Comfort
- ClinicalTrials.gov ID
- NCT05333575
- Acronym / sponsor ID
- SelcukUniversity
- Conditions
- Nutrition Disorder, Infant, Music, Preterm, Vital Signs
- Keywords
- preterm babies, cerebral oxygenation, lullabies, classical music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 19 Apr 2022 (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.
In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.
Detailed description
In the literature, there are many studies on prematurity pain and its relief. Although the vital signs and comfort levels of infants were examined in many applications for infants hospitalized in the neonatal intensive care unit, no study was found in which the cerebral oxygenation levels of infants were evaluated by NIRS by listening to lullabies and classical music to premature infants. There is no study in the literature examining cerebral oxygenation, vital signs and comfort parameters together during orogastric tube feeding, which is frequently used in preterm infants. For this reason, in this study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. It is thought that the study will present new data to the literature and will lead many researches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Research 28-34 preterm babies with gestational age hospitalized in the 2nd and 3rd level intensive care unit of Selcuk University Medical Faculty Hospital in Konya, Turkey. As a result of the power analysis, it was determined that the inclusion of 45 preterm infants in the study would provide sufficient sample size based on the two-sided hypothesis, 1.392 effect size, 0.05 margin of error and 0.95 power. Since the study period coincided with a period of uncertainties such as the Covid 19 pandemic, it was foreseen that there may be a loss in the number of babies included in the groups, and the sample number was increased by 10%, and the study was completed with a total of 51 premature babies (maternal voice group: 17, control group 17, classical music group 17).Babies of mothers who agreed to participate in the study were randomly assigned to the experimental and control groups. Simple randomization method was used in the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Lullaby | Experimental | Behavioral: LullabyThe mothers in this group sang lullabies to their babies next to the incubator during feeding. |
| Experimental Group: Classic Music | Experimental | Behavioral: Classic musicBabies in this group were listened to classical music during feeding. |
| Control Group | No intervention | –Premature newborns in the control group were fed according to the routine of the clinic and no intervention was performed other than routine practice. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being at 28-34 weeks of gestation,
- Stability (in terms of cerebral oxygenation, pain and vital signs) during enrollment,
- Not having any additional diagnosis other than the diagnosis of prematurity,
- Indication of bolus feeding with an orogastric tube,
Key exclusion criteria (5 listed)
- Congenital anomaly in the baby
- Diagnosed hearing impairment in the baby
- Having a history of an invasive procedure (such as a surgical operation) that will disrupt the baby's long-term comfort and cause pain
- The baby is receiving oxygen therapy or the baby is on mechanical ventilation
- Any history of disease affecting cerebral oxygenation (such as intraventricular hemorrhage, neonatal convulsions).
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 |
|---|---|---|
| LullabyThe mothers in this group were asked to sing a lullaby while their babies were fed with an orogastric tube. Mothers were released on lullabies. They were encouraged to sing the lullaby they knew or loved the most. The mother was given a sound decibel meter. Mothers were asked to do an application before going to the baby. It was taught that the number of sound decibels should not exceed 40 decibels while singing a lullaby. Later, the mother was taken to the baby's incubator at feeding time. She was seated in a chair. The working status of the decibel meter was checked and given to the mother. When the feeding started, the mother started singing lullabies and continued to sing until the feeding was finished. Attention was paid to aseptic techniques during all procedures. A single mother was asked to sing a lullaby at each feeding, and the baby of the mother who sang only a lullaby was included in the study. | Behavioural | Experimental Group: Lullaby |
| Classic musicThe babies in this group were given classical music recitals during feeding. The classical music piece Mozart-Baby Smart was preferred because it was seen to be used in the literature (Keidar 2014). Mozart-Baby Smart was loaded into the music player by the researcher before the feeding process. Before feeding, the decibel meter was disinfected by surface disinfectant and placed on sterile sponge in an incubator 10 cm away from the baby's head. The music player was turned on, not exceeding 40 decibels, by adjusting the decibel meter at the time of starting the feeding, and classical music was continued during the feeding. When the feeding was finished, the music player was turned off and the incubator was taken out. Attention was paid to acetic techniques during all procedures. Ambient sounds were tried to be controlled as much as possible so that the baby would not be affected by different sounds when listening to classical music. | Behavioural | Experimental Group: Classic Music |
Primary outcome
Newborn Information Form
Time frame: First measurement - Before intervention
This form was developed by the researcher using the literature (Loewy et al 2013, Caparros-Gonzalez et al 2018, Azarmnejad et al 2015, Alipour et al 2013). The form was composed of questions including introductory information about the baby, gestational age, postnatal age, gender, birth weight (gr), weight on the day of the intervention, type of delivery, 1st and 5th min apgar score.
Regional brain oxygen saturation (rSO2) levels
Time frame: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's rSO2 levels were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Heart rate (minute)
Time frame: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Oxygen saturation (%SpO2)
Time frame: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Body temperature (°C)
Time frame: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Respiratory rate (min)
Time frame: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
COMFORTneo Scale
Time frame: First measurement - one minute before the baby is fed
The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
6 secondary outcomes
Regional brain oxygen saturation (rSO2) levels
Time frame: Second measurement - immediately after feeding
Heart rate (minute)
Time frame: Second measurement - immediately after feeding
Oxygen saturation (%SpO2)
Time frame: Second measurement - immediately after feeding
Body temperature (°C)
Time frame: Second measurement - immediately after feeding
Respiratory rate (min)
Time frame: Second measurement - immediately after feeding
COMFORTneo Scale
Time frame: Second measurement - immediately after feeding
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 19 Apr 2022.
- Background: PubMed 24232665Keidar HR, Mandel D, Mimouni FB, Lubetzky R. Bach music in preterm infants: no 'Mozart effect' on resting energy expenditure. J Perinatol. 2014 Feb;34(2):153-5. doi: 10.1038/jp.2013.138. Epub 2013 Nov 14.
- Background: PubMed 23589814Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
- Background: PubMed 29045255Caparros-Gonzalez RA, de la Torre-Luque A, Diaz-Piedra C, Vico FJ, Buela-Casal G. Listening to Relaxing Music Improves Physiological Responses in Premature Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2018 Feb;18(1):58-69. doi: 10.1097/ANC.0000000000000448.
- Background: PubMed 26153174Azarmnejad E, Sarhangi F, Javadi M, Rejeh N. The Effect of Mother's Voice on Arterial Blood Sampling Induced Pain in Neonates Hospitalized in Neonate Intensive Care Unit. Glob J Health Sci. 2015 Apr 19;7(6):198-204. doi: 10.5539/gjhs.v7n6p198.
- Background: PubMed 23890458Alipour 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.
- Background: PubMed 19692803van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
- BackgroundKahraman A, Başbakkal Z, Yalaz M, 2014. Yenidoğan Konfor Davranış Ölçeği'nin Türkçe geçerlik ve güvenirliği. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi, 1, 2, 1-11.
- Derived from this study: PubMed 37737114Bagli E, Kucukoglu S, Soylu H. The Effect of Lullabies and Classical Music on Preterm Neonates' Cerebral Oxygenation, Vital Signs, and Comfort During Orogastric Tube Feeding: A Randomized Controlled Trial. Biol Res Nurs. 2024 Apr;26(2):181-191. doi: 10.1177/10998004231202404. Epub 2023 Sep 22.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
Sibel Kucukoglu, PhD study chair
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lullaby and Classic music in people with Nutrition Disorder, Infant and Music, run by Selcuk University at 2 sites 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 4 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Newborn Information Form (time frame: First measurement - Before intervention). The study lists 7 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 NCT05333575, which also lists 8 linked publications.
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 19 Apr 2022.