Newborn PainNCT06167551
The Effect of 3 Different Auditory Applications on Newborn Heel Prick Procedure
A study testing mother lullaby group, white noise group and classical music group in people with Newborn Pain, run by Namik Kemal University.
Trial summary
In pain management of neonates in interventional applications, health professionals should be able to evaluate pain, reduce or eliminate pain. Pharmacologic and nonpharmacologic methods are used in pain management. Pharmacological, opioid analgesics, sedatives and local anesthetics are used. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Newborn Pain
- What is being tested?
- mother lullaby group, white noise group and classical music group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Nov 2024
- 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 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The newborn must be between 38-42 weeks and weigh appropriately for his/her week (Appropriate Gestational Age - AGA),
- Not taking any analgesic, sedative or anticonvulsant medication for at least 6 hours before,
- Feeding at least 1 hour before,
- No fever,
- Not receiving oxygen therapy,
- Not receiving antibiotic treatment
Show all 10Show fewer
- No congenital anomalies
- Not next to the bed or under the heater
- Not receiving phototherapy,
- Not being connected to a mechanical ventilator
Who cannot join
- Presence of congenital anomaly,
- Having a chest tube inserted,
- Intracranial bleeding,
- Presence of anomaly that may cause deafness
- Those with a history of epileptic seizures will be excluded.
- The patient's family refuses to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of 3 Different Auditory Applications on Pain, Crying Duration and Physiological Parameters During Newborn Heel Prick Procedures
In pain management of neonates in interventional applications, health professionals should be able to evaluate pain, reduce or eliminate pain. Pharmacologic and nonpharmacologic methods are used in pain management. Pharmacological, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, giving pacifiers, oral sucrose, music, massage, therapeutic touch and nesting, positioning such as fetal positioning, wrapping, kangaroo care, rocking and cradling.
Music makes positive changes in oxygen saturation level and peak heart rate values and reduces stress and pain. Classical music with light rhythmic emphasis and steady rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
This study was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise song by the mother to the newborn before and during heel prick blood collection with the control group and to determine which application gives superior results to the newborn's pain level, crying time and physiological parameters.
Read the detailed description
In pain management of newborns in interventional applications, health professionals should be able to evaluate pain and reduce or eliminate pain. Pharmacological and non-pharmacological methods are used in the management of pain. Non-pharmacological methods: practices such as breastfeeding, giving a pacifier, giving oral sucrose, listening to music, massage, therapeutic touching and nesting, positioning the fetus such as wrapping, giving kangaroo care, rocking and holding.
The newborn's response to sound often leads to changes in breathing and heart rate. Mild to moderate sounds (55-75 dB), such as speech and music, cause a decrease in heart rate and create an orientation response. Music makes positive changes in oxygen saturation level and heart rate peak values, and also reduces stress and pain. Arnon et al. determined that letting newborns in intensive care listen to music has a positive effect on reducing pain and anxiety, making it easier for newborns to fall asleep and increasing their sleep quality. Classical music with a light rhythmic emphasis and constant rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with a female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
Heel prick pricking in newborns causes pain, which results in increased blood pressure and pulse rate, decreased SpO2, and crying. For this reason, this study was designed as a randomized controlled experimental design to compare the classical music and white noise and lullaby applications to the newborn before and during heel blood collection with the control group and to determine which application provides superior results on the newborn's pain level, crying duration and physiological parameters.
Research Purpose and Type This research was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise aplications to the newborn during the heel prick prick procedure with the control group.
Research Variables Independent variables; Lullaby your mother sings, white noise, classical music Dependent variables; Heart rate peak (HRV), oxygen saturation (SpO2), NIPS score, NIAPAS score, crying duration.
Place and Time to Conduct the Research The research will be carried out between February 2024 and June 2024 in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital.
The population of the research It will create term newborns born at 38-42 weeks of gestation in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital between February 2024 and June 2024. Postpartum 24-72. These are the newborns whose heel blood will be taken during Sample; The sample number of the study was determined by power analysis. The thesis study, which evaluated the effect of different auditory interventions on pain in heel blood collection in newborns, was taken as an example. According to the NIPS pain assessment scale used in the study, the average score of the results during the procedure was 4.26±2.16 in the 1st experimental group, 4.81±2.18 in the 2nd experimental group, 5.02±2.00 in the 3rd experimental group, and 5.93±1.32 in the control group. In this study, it was anticipated that the NIPS score average difference would have a large effect size (.95 large effect), with a 5% alpha margin of error (two-sided) and 80% power, and in the calculation of the number of samples made in the G*Power (3.1.9.2.) program, each It was determined that 20 babies should be included in a group, 80 babies in total. Considering that there may be sample loss for any reason during the research, the aim is to reach 96 newborns (24 babies in each group) by increasing the number of babies by 20% and using statistical parametric analysis methods.
The sample will be randomly selected from the study population. In the study, randomization will be performed using the URN method, which is considered equivalent to the full randomization method. Although this method is shown as UD, it includes two parameters, α and β. These represent balls of two different colors (for example: red and white). α can be white or red, while β will be the exact opposite of the chosen ball colour. One of the balls is chosen randomly, and if the selected ball is white, the subject is assigned to the α group, and if it is red, the subject is assigned to the β group. This selection process is repeated to determine which group the subject will be in.
In the research, the red ball will be the mother's lullaby (intervention group 1), the yellow ball will be white noise (intervention group 2), the blue ball will be classical music (intervention group 3), and the white ball will be the control group. When there is a baby in the clinic that meets the sample selection conditions, these balls prepared by the researcher will be placed in an invisible, dark-colored bag and a random nurse working in the ward will be able to make the selection without seeing it. Which group the baby will be placed in will be determined by the color of the ball coming out of the bag, and the babies will be distributed randomly to the groups.
- Conditions
- Newborn Pain
- Being tested
- mother lullaby group, white noise group, classical music group, Contol Group
- Keywords
- newborn, heel prick, music, pain care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mother lullaby groupOther
mother's lullaby: the mother will be made to sing her own lullaby 5 minutes before the heel prick.
white noise groupOther
white noise: 5 minutes before taking heel prick blood, white noise will be started to be played on an MP3 player with white noise. The MP3 player will be placed in the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels.
classical music groupOther
classical music: 5 minutes before heel prick, classical music will be started to be played from the MP3 player with white noise. The MP3 will be placed inside the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels.
Contol GroupOther
Also called No intervation
No intervation
| Study group | Role | What they receive |
|---|---|---|
| mother lullaby group | Experimental | group listening to mother's lullaby Receives: Other: mother lullaby group |
| white noise group | Experimental | group listening to white noise Receives: Other: white noise group |
| classical music group | Experimental | group listening to classical music Receives: Other: classical music group |
| Control group | Other | No intervation Receives: Other: Contol Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac apex beat (HRV)
HRV will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
Measured: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
Oxygen saturation (SpO2)
SpO2 will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
Measured: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
NIPS scale score
The scale is used to evaluate pain due to procedures performed in term and premature babies. NIPS consists of sections that evaluate 6 behaviors against pain (crying, breathing pattern, arm and leg movements and alertness). Although the total score varies between 0-7, a higher score indicates greater pain intensity.
Measured: NIPS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
NIAPAS scale score
NIAPAS scale measures acute pain; It is a scale that includes five behavioral and three physiological indicators given the week of gestation as a contextual factor. As a result of the scoring of the indicators, the score that can be obtained from the scale is between 0-18. Pain intensity is classified as mild pain (0-5), moderate pain (6-9) and severe pain (10-18).
Measured: NIAPAS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
Crying time
The baby's crying time will be monitored and recorded.
Measured: The baby's crying time will be 5 minutes before the heel prick and 5 minutes during the heel prick.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Newborn PainStudies 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
- Model description
- Comparison of 3 different auditory applications with the control group during heel prick collection in newborns.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynem YILDIRIM BALKAN, Namik Kemal University
- Investigators
- Serap BALCI, PHD, Study director, ISTANBUL UNİVERSİTY CERRAHPAŞA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167551
- Sponsor's protocol ID
- TNKU-Z.BALKAN-1
- Status last verified
- Dec 2023
- First submitted
- 4 Oct 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
PubMed 16732778Balcı, S. (2006). Beyaz Gürültünün Kolikli Bebeklerde Etkisi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü Çocuk Sağlığı ve Hastalıkları Hemşireliği Anabilim Dalı. Yüksek Lisans Tezi. İstanbul, Türkiye.
Balcı, S., Dur, Ş., Özdemir, Ş., & Kavuncuoğlu, S. (2021). The effect of two different lancets and heel warming on duration of crying and procedure time during blood sampling: A randomized controlled study. Journal of Neonatal Nursing, 27(6), 426-431.
Derebent, E., & Yiğit, R. (2008). Yenidoğanda Non-Farmakolojik Ağrı Yönetimi. Fırat Üniversitesi Sağlık Bilimleri Tıp Dergisi, 22(2), 113.
Gilad, E., & Arnon, S. (2010). The role of live music and singing as a stress-reducing modality in the neonatal intensive care unit environment. Music and Medicine, 2(1), 18-22
Gooding, L. F. (2010). Using music therapy protocols in the treatment of premature infants: An introduction to current practices. The arts in Psychotherapy, 37(3), 211-214
İmseytoğlu, D., & Yıldız, S. (2012). YENİDOĞAN YOĞUN BAKIM ÜNİTELERİNDE MÜZİK TERAPİ. Florence Nightingale Journal of Nursing, 20(2), 160-165.
Kanbur BN, Mutlu B, Salihoglu O. Validity and reliability of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) in Turkish: prospective study. Sao Paulo Med J. 2021 Jul-Aug;139(4):305-311. doi: 10.1590/1516-3180.2020.0721.R1.23122020.
PubMed 34346962Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.
PubMed 22290677Standley, J. M. (2012). A discussion of evidence-based music therapy to facilitate feeding skills of premature infants: The power of contingent music. The arts in Psychotherapy, 39(5), 379-382.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 3 Different Auditory Applications on Pain, Crying Duration and Physiological Parameters During Newborn Heel Prick Procedures
- ClinicalTrials.gov ID
- NCT06167551
- Acronym / sponsor ID
- TNKU-Z.BALKAN-1
- Conditions
- Newborn Pain
- Keywords
- newborn, heel prick, music, pain care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 12 Dec 2023 (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 pain management of neonates in interventional applications, health professionals should be able to evaluate pain, reduce or eliminate pain. Pharmacologic and nonpharmacologic methods are used in pain management. Pharmacological, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, giving pacifiers, oral sucrose, music, massage, therapeutic touch and nesting, positioning such as fetal positioning, wrapping, kangaroo care, rocking and cradling.
Music makes positive changes in oxygen saturation level and peak heart rate values and reduces stress and pain. Classical music with light rhythmic emphasis and steady rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
This study was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise song by the mother to the newborn before and during heel prick blood collection with the control group and to determine which application gives superior results to the newborn's pain level, crying time and physiological parameters.
Detailed description
In pain management of newborns in interventional applications, health professionals should be able to evaluate pain and reduce or eliminate pain. Pharmacological and non-pharmacological methods are used in the management of pain. Non-pharmacological methods: practices such as breastfeeding, giving a pacifier, giving oral sucrose, listening to music, massage, therapeutic touching and nesting, positioning the fetus such as wrapping, giving kangaroo care, rocking and holding.
The newborn's response to sound often leads to changes in breathing and heart rate. Mild to moderate sounds (55-75 dB), such as speech and music, cause a decrease in heart rate and create an orientation response. Music makes positive changes in oxygen saturation level and heart rate peak values, and also reduces stress and pain. Arnon et al. determined that letting newborns in intensive care listen to music has a positive effect on reducing pain and anxiety, making it easier for newborns to fall asleep and increasing their sleep quality. Classical music with a light rhythmic emphasis and constant rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with a female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
Heel prick pricking in newborns causes pain, which results in increased blood pressure and pulse rate, decreased SpO2, and crying. For this reason, this study was designed as a randomized controlled experimental design to compare the classical music and white noise and lullaby applications to the newborn before and during heel blood collection with the control group and to determine which application provides superior results on the newborn's pain level, crying duration and physiological parameters.
Research Purpose and Type This research was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise aplications to the newborn during the heel prick prick procedure with the control group.
Research Variables Independent variables; Lullaby your mother sings, white noise, classical music Dependent variables; Heart rate peak (HRV), oxygen saturation (SpO2), NIPS score, NIAPAS score, crying duration.
Place and Time to Conduct the Research The research will be carried out between February 2024 and June 2024 in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital.
The population of the research It will create term newborns born at 38-42 weeks of gestation in the Neonatal Intensive Care Unit of Gaziantep Cengiz Gökçek Gynecology and Children's Hospital between February 2024 and June 2024. Postpartum 24-72. These are the newborns whose heel blood will be taken during Sample; The sample number of the study was determined by power analysis. The thesis study, which evaluated the effect of different auditory interventions on pain in heel blood collection in newborns, was taken as an example. According to the NIPS pain assessment scale used in the study, the average score of the results during the procedure was 4.26±2.16 in the 1st experimental group, 4.81±2.18 in the 2nd experimental group, 5.02±2.00 in the 3rd experimental group, and 5.93±1.32 in the control group. In this study, it was anticipated that the NIPS score average difference would have a large effect size (.95 large effect), with a 5% alpha margin of error (two-sided) and 80% power, and in the calculation of the number of samples made in the G*Power (3.1.9.2.) program, each It was determined that 20 babies should be included in a group, 80 babies in total. Considering that there may be sample loss for any reason during the research, the aim is to reach 96 newborns (24 babies in each group) by increasing the number of babies by 20% and using statistical parametric analysis methods.
The sample will be randomly selected from the study population. In the study, randomization will be performed using the URN method, which is considered equivalent to the full randomization method. Although this method is shown as UD, it includes two parameters, α and β. These represent balls of two different colors (for example: red and white). α can be white or red, while β will be the exact opposite of the chosen ball colour. One of the balls is chosen randomly, and if the selected ball is white, the subject is assigned to the α group, and if it is red, the subject is assigned to the β group. This selection process is repeated to determine which group the subject will be in.
In the research, the red ball will be the mother's lullaby (intervention group 1), the yellow ball will be white noise (intervention group 2), the blue ball will be classical music (intervention group 3), and the white ball will be the control group. When there is a baby in the clinic that meets the sample selection conditions, these balls prepared by the researcher will be placed in an invisible, dark-colored bag and a random nurse working in the ward will be able to make the selection without seeing it. Which group the baby will be placed in will be determined by the color of the ball coming out of the bag, and the babies will be distributed randomly to the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Comparison of 3 different auditory applications with the control group during heel prick collection in newborns.
| Arm | Type | Receives |
|---|---|---|
| mother lullaby group | Experimental | Other: mother lullaby groupgroup listening to mother's lullaby |
| white noise group | Experimental | Other: white noise groupgroup listening to white noise |
| classical music group | Experimental | Other: classical music groupgroup listening to classical music |
| Control group | Other | Other: Contol GroupNo intervation |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- The newborn must be between 38-42 weeks and weigh appropriately for his/her week (Appropriate Gestational Age - AGA),
- Not taking any analgesic, sedative or anticonvulsant medication for at least 6 hours before,
- Feeding at least 1 hour before,
- No fever,
- Not receiving oxygen therapy,
Key exclusion criteria (6 listed)
- Presence of congenital anomaly,
- Having a chest tube inserted,
- Intracranial bleeding,
- Presence of anomaly that may cause deafness
- Those with a history of epileptic seizures will be excluded.
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 |
|---|---|---|
| mother lullaby groupmother's lullaby: the mother will be made to sing her own lullaby 5 minutes before the heel prick. | Other | mother lullaby group |
| white noise groupwhite noise: 5 minutes before taking heel prick blood, white noise will be started to be played on an MP3 player with white noise. The MP3 player will be placed in the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels. | Other | white noise group |
| classical music groupclassical music: 5 minutes before heel prick, classical music will be started to be played from the MP3 player with white noise. The MP3 will be placed inside the crib where the baby lies, at the baby's bedside, at least 20 cm away from the baby's head. After the MP3 player is turned on, the sound level will be measured at the baby's ear level with a decibel meter and adjusted so that it does not exceed 70 decibels. | Other | classical music group |
| Contol GroupAlso: No intervationNo intervation | Other | Control group |
Primary outcome
Cardiac apex beat (HRV)
Time frame: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
HRV will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
Oxygen saturation (SpO2)
Time frame: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
SpO2 will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
NIPS scale score
Time frame: NIPS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
The scale is used to evaluate pain due to procedures performed in term and premature babies. NIPS consists of sections that evaluate 6 behaviors against pain (crying, breathing pattern, arm and leg movements and alertness). Although the total score varies between 0-7, a higher score indicates greater pain intensity.
NIAPAS scale score
Time frame: NIAPAS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
NIAPAS scale measures acute pain; It is a scale that includes five behavioral and three physiological indicators given the week of gestation as a contextual factor. As a result of the scoring of the indicators, the score that can be obtained from the scale is between 0-18. Pain intensity is classified as mild pain (0-5), moderate pain (6-9) and severe pain (10-18).
Crying time
Time frame: The baby's crying time will be 5 minutes before the heel prick and 5 minutes during the heel prick.
The baby's crying time will be monitored and recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 16732778Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
- BackgroundBalcı, S. (2006). Beyaz Gürültünün Kolikli Bebeklerde Etkisi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü Çocuk Sağlığı ve Hastalıkları Hemşireliği Anabilim Dalı. Yüksek Lisans Tezi. İstanbul, Türkiye.
- BackgroundBalcı, S., Dur, Ş., Özdemir, Ş., & Kavuncuoğlu, S. (2021). The effect of two different lancets and heel warming on duration of crying and procedure time during blood sampling: A randomized controlled study. Journal of Neonatal Nursing, 27(6), 426-431.
- BackgroundDerebent, E., & Yiğit, R. (2008). Yenidoğanda Non-Farmakolojik Ağrı Yönetimi. Fırat Üniversitesi Sağlık Bilimleri Tıp Dergisi, 22(2), 113.
- BackgroundGilad, E., & Arnon, S. (2010). The role of live music and singing as a stress-reducing modality in the neonatal intensive care unit environment. Music and Medicine, 2(1), 18-22
- BackgroundGooding, L. F. (2010). Using music therapy protocols in the treatment of premature infants: An introduction to current practices. The arts in Psychotherapy, 37(3), 211-214
- Backgroundİmseytoğlu, D., & Yıldız, S. (2012). YENİDOĞAN YOĞUN BAKIM ÜNİTELERİNDE MÜZİK TERAPİ. Florence Nightingale Journal of Nursing, 20(2), 160-165.
- Background: PubMed 34346962Kanbur BN, Mutlu B, Salihoglu O. Validity and reliability of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) in Turkish: prospective study. Sao Paulo Med J. 2021 Jul-Aug;139(4):305-311. doi: 10.1590/1516-3180.2020.0721.R1.23122020.
- Background: PubMed 22290677Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.
- BackgroundStandley, J. M. (2012). A discussion of evidence-based music therapy to facilitate feeding skills of premature infants: The power of contingent music. The arts in Psychotherapy, 39(5), 379-382.
- Individual participant dataSharing planned: No
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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.
Serap BALCI, PHD study director
ISTANBUL UNİVERSİTY CERRAHPAŞA
Questions about this trial
What is this clinical trial studying?
A study testing mother lullaby group, white noise group and classical music group in people with Newborn Pain, run by Namik Kemal University.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynem YILDIRIM BALKAN, PHD (+905073190958, zyildirim@nku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac apex beat (HRV) (time frame: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.). 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 NCT06167551, which also lists 10 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 18 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.