Neonatal Intensive CareNCT05253625
The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
A study testing Listening to a recorded lullaby. in people with Neonatal Intensive Care and Music Therapy, run by Izmir Tinaztepe University.
Trial summary
Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Neonatal Intensive Care, Music Therapy, Pain Responses
- What is being tested?
- Listening to a recorded lullaby.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2022to 30 Jun 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At 32-36+6 weeks of gestation
- Stable first 24 hours after birth
- Not dependent on mechanical ventilation
- Non-intubated
- Without a congenital and/or acquired malformation of hearing
- No congenital defect • Without hyperbilirinemia
Show all 10Show fewer
- Not taking analgesics and/or sedatives in the last 24 hours
- If no painful application has been made to the newborn in the last hour (eg, blood collection, aspiration, eye examination, etc.)
- Postnatal age of 1-7 days
- Preterms whose height and weight are above the 10% percentile according to the week of gestation
Who cannot join
- Deterioration in general condition
- Those who do not meet the criteria for inclusion in the research
- Preterms whose parents did not consent to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. In such cases, newborns may frequently be exposed to repetitive painful interventions (like IV catherization). Pain in the postnatal period can cause physiological, behavioral and metabolic changes, and changes in the functional processing related with somatosensation and pain in the long term. In this context, inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants.
For these reasons, it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological and/or non-pharmacological interventions. In the intrauterine 20th week, the ability to hear begins to form, and in the 26-28th weeks the level to respond to sounds is achieved. Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks. Especially in the 32nd gestational week, preterm newborns begin to develop the ability to distinguish mother's voice from other sounds with regard to rhythm and intonation. Due to this developmental feature of preterm newborns, it is recommended to use the mother's voice in neonatal intensive care units. However, studies on this subject are very limited.
The main goal of care in neonatal intensive care units is to maintain the baby's life and comfort at the highest level, to minimize pain and suffering, and to ensure that it can cope with pain. In the light of all information, it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics. The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units. The participants will be devided in three groups. The first group will listen to the lulliby recorded with the mothers voice, the second group will listen to the the lulliby recorded with the voice of an unfamilliar female, and the third group will not listen to a lulliby. The effects will be measured by using three physiologic parameters (oxygen saturation, heart rate, and respiratory rate) and pain responses (Neonatai Infant Pain Scala) before, during, and after a painful intervention (IV catherization).
- Conditions
- Neonatal Intensive Care, Music Therapy, Pain Responses
- Being tested
- Listening to a recorded lullaby.
- Keywords
- premature, pain, lullaby
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to a recorded lullaby.Other
A lullaby will be played from the MP4 player on the outer foot of an empty incubator, and a decibel meter (dB) will be placed in the empty incubator, so that the maximum level of the decibel meter does not exceed 50-60 dB (45-65 dB according to APA). ) (American Academy of Pediatrics. ACOG.2007) (Guidelines for Pediatrics Care. 7th edition) sound adjustment will be made. The lullaby with the mother's voice (first arm newborn mothers) adn with an unfamiliar female voice (second arm newborns) will be recorded in MP4 beforehand. The lullabies of groups A and B are lullabies performed in approximately 4 minutes and will be played repeatedly for the specified periods.
| Study group | Role | What they receive |
|---|---|---|
| lullaby mother | Experimental | The participant will listen to a lullaby recorded with his mothers voice. Receives: Other: Listening to a recorded lullaby. |
| lullaby female | Experimental | The participant will listen to a lullaby recorded with a foreign female voice. Receives: Other: Listening to a recorded lullaby. |
| no lullaby | No intervention | The participant will not listen to a lullaby. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of NIPS (Neonatal Infant Pain Scale) Score
Pain response according to Neonatal Infant Pain Scale
Measured: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Change of SpO2 (Oxygen Concentration)
Oxygen saturation
Measured: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Change of HR (Heart Rate)
Heart rate
Measured: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Change of RR (Respiratory Rate)
Respiratory rate
Measured: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start8 Mar 2022 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive CareStudies 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
- Factorial
- Model description
- The participants will be assigned to three groups. Before, during and after a painful intervention the first group (Group A) will listen to a lullaby recorded with the mothers voice, the second group (Group B) will listen to a lullaby recorded with a unfamiliar female voice, and the third group (Group C) without and intervention (no lullaby).
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilüfer Özgürbüz, Izmir Tinaztepe University
- Investigators
- Nilüfer Özgürbüz, PhD, Principal investigator, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253625
- Sponsor's protocol ID
- IzmirTinaztepeU NOzgurbuz
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
PubMed 16580851de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.
PubMed 25511005Halimaa SL, Vehvilainen-Julkunen K, Heinonen K. Knowledge, assessment and management of pain related to nursing procedures used with premature babies: questionnaire study for caregivers. Int J Nurs Pract. 2001 Dec;7(6):422-30. doi: 10.1046/j.1440-172x.2001.00322.x.
PubMed 11785445Yigit S, Ecevit A, Koroglu OA. Turkish Neonatal Society guideline on the neonatal pain and its management. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S161-S171. doi: 10.5152/TurkPediatriArs.2018.01802. eCollection 2018.
PubMed 31236029American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
PubMed 17079598Levitin DJ, Tirovolas AK. Current advances in the cognitive neuroscience of music. Ann N Y Acad Sci. 2009 Mar;1156:211-31. doi: 10.1111/j.1749-6632.2009.04417.x.
PubMed 19338510Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
PubMed 27561729Dehaene-Lambertz G, Montavont A, Jobert A, Allirol L, Dubois J, Hertz-Pannier L, Dehaene S. Language or music, mother or Mozart? Structural and environmental influences on infants' language networks. Brain Lang. 2010 Aug;114(2):53-65. doi: 10.1016/j.bandl.2009.09.003. Epub 2009 Oct 27.
PubMed 19864015Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.
PubMed 12029604Cevasco AM. The effects of mothers' singing on full-term and preterm infants and maternal emotional responses. J Music Ther. 2008 Fall;45(3):273-306. doi: 10.1093/jmt/45.3.273.
PubMed 18959452Loewy 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 23589814Vianna MN, Barbosa AP, Carvalhaes AS, Cunha AJ. Music therapy may increase breastfeeding rates among mothers of premature newborns: a randomized controlled trial. J Pediatr (Rio J). 2011 May-Jun 8;87(3):206-12. doi: 10.2223/JPED.2086. Epub 2011 Apr 1. English, Portuguese.
PubMed 21461451
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
- ClinicalTrials.gov ID
- NCT05253625
- Acronym / sponsor ID
- IzmirTinaztepeU NOzgurbuz
- Conditions
- Neonatal Intensive Care, Music Therapy, Pain Responses
- Keywords
- premature, pain, lullaby
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 8 Mar 2022 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 24 Feb 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.
Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. In such cases, newborns may frequently be exposed to repetitive painful interventions (like IV catherization). Pain in the postnatal period can cause physiological, behavioral and metabolic changes, and changes in the functional processing related with somatosensation and pain in the long term. In this context, inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants.
For these reasons, it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological and/or non-pharmacological interventions. In the intrauterine 20th week, the ability to hear begins to form, and in the 26-28th weeks the level to respond to sounds is achieved. Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks. Especially in the 32nd gestational week, preterm newborns begin to develop the ability to distinguish mother's voice from other sounds with regard to rhythm and intonation. Due to this developmental feature of preterm newborns, it is recommended to use the mother's voice in neonatal intensive care units. However, studies on this subject are very limited.
The main goal of care in neonatal intensive care units is to maintain the baby's life and comfort at the highest level, to minimize pain and suffering, and to ensure that it can cope with pain. In the light of all information, it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics. The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units. The participants will be devided in three groups. The first group will listen to the lulliby recorded with the mothers voice, the second group will listen to the the lulliby recorded with the voice of an unfamilliar female, and the third group will not listen to a lulliby. The effects will be measured by using three physiologic parameters (oxygen saturation, heart rate, and respiratory rate) and pain responses (Neonatai Infant Pain Scala) before, during, and after a painful intervention (IV catherization).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The participants will be assigned to three groups. Before, during and after a painful intervention the first group (Group A) will listen to a lullaby recorded with the mothers voice, the second group (Group B) will listen to a lullaby recorded with a unfamiliar female voice, and the third group (Group C) without and intervention (no lullaby).
| Arm | Type | Receives |
|---|---|---|
| lullaby mother | Experimental | Other: Listening to a recorded lullaby.The participant will listen to a lullaby recorded with his mothers voice. |
| lullaby female | Experimental | Other: Listening to a recorded lullaby.The participant will listen to a lullaby recorded with a foreign female voice. |
| no lullaby | No intervention | –The participant will not listen to a lullaby. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- At 32-36+6 weeks of gestation
- Stable first 24 hours after birth
- Not dependent on mechanical ventilation
- Non-intubated
- Without a congenital and/or acquired malformation of hearing
Key exclusion criteria (3 listed)
- Deterioration in general condition
- Those who do not meet the criteria for inclusion in the research
- Preterms whose parents did not consent to participate in the study
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 a recorded lullaby.A lullaby will be played from the MP4 player on the outer foot of an empty incubator, and a decibel meter (dB) will be placed in the empty incubator, so that the maximum level of the decibel meter does not exceed 50-60 dB (45-65 dB according to APA). ) (American Academy of Pediatrics. ACOG.2007) (Guidelines for Pediatrics Care. 7th edition) sound adjustment will be made. The lullaby with the mother's voice (first arm newborn mothers) adn with an unfamiliar female voice (second arm newborns) will be recorded in MP4 beforehand. The lullabies of groups A and B are lullabies performed in approximately 4 minutes and will be played repeatedly for the specified periods. | Other | lullaby female, lullaby mother |
Primary outcome
Change of NIPS (Neonatal Infant Pain Scale) Score
Time frame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Pain response according to Neonatal Infant Pain Scale
Change of SpO2 (Oxygen Concentration)
Time frame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Oxygen saturation
Change of HR (Heart Rate)
Time frame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Heart rate
Change of RR (Respiratory Rate)
Time frame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Respiratory rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 16580851Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
- Background: PubMed 25511005de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.
- Background: PubMed 11785445Halimaa SL, Vehvilainen-Julkunen K, Heinonen K. Knowledge, assessment and management of pain related to nursing procedures used with premature babies: questionnaire study for caregivers. Int J Nurs Pract. 2001 Dec;7(6):422-30. doi: 10.1046/j.1440-172x.2001.00322.x.
- Background: PubMed 31236029Yigit S, Ecevit A, Koroglu OA. Turkish Neonatal Society guideline on the neonatal pain and its management. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S161-S171. doi: 10.5152/TurkPediatriArs.2018.01802. eCollection 2018.
- Background: PubMed 17079598American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
- Background: PubMed 19338510Levitin DJ, Tirovolas AK. Current advances in the cognitive neuroscience of music. Ann N Y Acad Sci. 2009 Mar;1156:211-31. doi: 10.1111/j.1749-6632.2009.04417.x.
- Background: PubMed 27561729Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
- Background: PubMed 19864015Dehaene-Lambertz G, Montavont A, Jobert A, Allirol L, Dubois J, Hertz-Pannier L, Dehaene S. Language or music, mother or Mozart? Structural and environmental influences on infants' language networks. Brain Lang. 2010 Aug;114(2):53-65. doi: 10.1016/j.bandl.2009.09.003. Epub 2009 Oct 27.
- Background: PubMed 12029604Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.
- Background: PubMed 18959452Cevasco AM. The effects of mothers' singing on full-term and preterm infants and maternal emotional responses. J Music Ther. 2008 Fall;45(3):273-306. doi: 10.1093/jmt/45.3.273.
- 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 21461451Vianna MN, Barbosa AP, Carvalhaes AS, Cunha AJ. Music therapy may increase breastfeeding rates among mothers of premature newborns: a randomized controlled trial. J Pediatr (Rio J). 2011 May-Jun 8;87(3):206-12. doi: 10.2223/JPED.2086. Epub 2011 Apr 1. English, Portuguese.
- 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.
Nilüfer Özgürbüz, PhD principal investigator
Izmir Tinaztepe University
Questions about this trial
What is this clinical trial studying?
A study testing Listening to a recorded lullaby. in people with Neonatal Intensive Care and Music Therapy, run by Izmir Tinaztepe 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 3 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 8 Mar 2022. 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 NİLÜFER ÖZGÜRBÜZ, PhD (+905064848810, niluferozgurbuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of NIPS (Neonatal Infant Pain Scale) Score (time frame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.). 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?
On the ClinicalTrials.gov record for NCT05253625, which also lists 12 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 8 Mar 2022.