PretermNCT05830955
The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
A study testing Lullaby group and Breast milk group in people with Preterm and Infant, Premature, Diseases, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of… Read more about this study
- Who is it for?
- Ages 35 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Infant, Premature, Diseases, Postpartum Depression
- What is being tested?
- Lullaby group and Breast milk group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 5 Mar 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 35 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents' willingness to participate in the study
- Turkish literate parents
- Babies between 35-37 weeks of gestation
- Apgar score of 7 or higher at birth
- Stability of the baby (near discharge)
- Having mother's milk
Who cannot join
- Parents' reluctance to participate in the study
- Babies younger than 35 weeks and older than 37 weeks
- Babies receiving phototherapy
- Finding a congenital anomaly in infants
- Apgar score below 7 at birth
- Being connected to a mechanical ventilator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns
The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. The main hypothesis are:
H0: The live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H1: The live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H2: The breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H3: There is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels.
Read more
H4: The postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group.
Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
- Being tested
- Lullaby group, Breast milk group, Control group
- Keywords
- Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression
- Medical subject headings
- Premature Birth, Infant, Premature, Diseases, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lullaby groupOther
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Breast milk groupOther
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Control groupOther
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
| Study group | Role | What they receive |
|---|---|---|
| Lullaby Group | Experimental | The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). Receives: Other: Lullaby group |
| Breast milk Group | Experimental | The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. Receives: Other: Breast milk group |
| Control Group | Other | The preterms in the third group (Control group) are going to recieve rutin nursing care interventions. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate change
Heart Rate change before, during and after the intervention
Measured: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Oxygen Saturation change
Oxygen Saturation change before, during and after the intervention
Measured: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Respiration Rate change
Respiration Rate change before, during and after the intervention
Measured: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Body Temperature change
Body Temperature change before, during and after the intervention
Measured: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Comfort level change
Premature Infant Comfort Behavior Scale (ComfortNeo) will be used before, during and after the intervention. Each item of this five-point Likert scale is scored from 1 to 5 from bad to good. The baby's comfort is evaluated according to the total score. Accordingly, 30 indicates the lowest and 6 the highest comfort score. A high score on the scale indicates a low level of comfort.
Measured: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
Maternal Attachment
Maternal Attachment Scale This scale consists of 26 items and is in 4-point Likert type. "Always" is calculated as 4 points, "often" as 3 points, "sometimes" as 2 points, and "never" as 1 point. An overall score is obtained from the sum of all items. The lowest score to be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment.
Measured: 28 days after discharge
Postpartum Depression
Edinburgh Postpartum Depression Scale The scale is in the form of a four-point Likert scale and consists of a total of 10 items. Items 1,2 and 4 are scored as 0,1,2,3 and other items as 3,2,1.0. The lowest possible score is 0 and the highest score is 30.
Measured: Before the interventions and 28 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start15 May 2023
- Primary completion4 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PretermStudies 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
- Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Yuzuncu Yil University, Van Training and Research Hospital
- Responsible party
- Principal investigator, Gizem Kerimoğlu Yıldız, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830955
- Sponsor's protocol ID
- Hatay Mustafa Kemal University
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers have not planned to share any individual participant data yet.
Publications
Rattaz C, Goubet N, Bullinger A. The calming effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2005 Apr;26(2):86-92. doi: 10.1097/00004703-200504000-00003.
PubMed 15827459Namjoo R, Mehdipour-Rabori R, Bagherian B, Nematollahi M. Comparing the effectiveness of mother's live lullaby and recorded lullaby on physiological responses and sleep of preterm infants: a clinical trial study. J Complement Integr Med. 2021 May 24;19(1):121-129. doi: 10.1515/jcim-2020-0507.
PubMed 34022122Cignacco E, Hamers JP, van Lingen RA, Zimmermann LJ, Muller R, Gessler P, Nelle M. Pain relief in ventilated preterms during endotracheal suctioning: a randomized controlled trial. Swiss Med Wkly. 2008 Nov 1;138(43-44):635-45. doi: 10.4414/smw.2008.12288.
PubMed 19005869Lessen Knoll BS, Daramas T, Drake V. Randomized Controlled Trial of a Prefeeding Oral Motor Therapy and Its Effect on Feeding Improvement in a Thai NICU. J Obstet Gynecol Neonatal Nurs. 2019 Mar;48(2):176-188. doi: 10.1016/j.jogn.2019.01.003. Epub 2019 Feb 2.
PubMed 30721652da Silva CM, Cacao JM, Silva KC, Marques CF, Merey LS. Physiological responses of preterm newborn infants submitted to classical music therapy. Rev Paul Pediatr. 2013 Jan-Mar;31(1):30-6. doi: 10.1590/s0103-05822013000100006. English, Portuguese.
PubMed 23703041Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.
PubMed 15205733Kurt FY, Kucukoglu S, Ozdemir AA, Ozcan Z. The effect of kangaroo care on maternal attachment in preterm infants. Niger J Clin Pract. 2020 Jan;23(1):26-32. doi: 10.4103/njcp.njcp_143_18.
PubMed 31929203Loewy 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 23589814Alipour 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 23890458Taheri L, Jahromi MK, Abbasi M, Hojat M. Effect of recorded male lullaby on physiologic response of neonates in NICU. Appl Nurs Res. 2017 Feb;33:127-130. doi: 10.1016/j.apnr.2016.11.003. Epub 2016 Nov 9.
PubMed 28096005
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns
- ClinicalTrials.gov ID
- NCT05830955
- Acronym / sponsor ID
- Hatay Mustafa Kemal University
- Keywords
- Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Yuzuncu Yil University, Van Training and Research Hospital
- Study start
- 15 May 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 26 Apr 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.
The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. The main hypothesis are:
H0: The live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H1: The live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H2: The breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H3: There is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels.
H4: The postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group.
Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
| Arm | Type | Receives |
|---|---|---|
| Lullaby Group | Experimental | Other: Lullaby groupThe preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). |
| Breast milk Group | Experimental | Other: Breast milk groupThe preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. |
| Control Group | Other | Other: Control groupThe preterms in the third group (Control group) are going to recieve rutin nursing care interventions. |
Who may qualify
- Ages
- 35 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parents' willingness to participate in the study
- Turkish literate parents
- Babies between 35-37 weeks of gestation
- Apgar score of 7 or higher at birth
- Stability of the baby (near discharge)
Key exclusion criteria (6 listed)
- Parents' reluctance to participate in the study
- Babies younger than 35 weeks and older than 37 weeks
- Babies receiving phototherapy
- Finding a congenital anomaly in infants
- Apgar score below 7 at birth
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 |
|---|---|---|
| Lullaby groupThe preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). | Other | Lullaby Group |
| Breast milk groupThe preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. | Other | Breast milk Group |
| Control groupThe preterms in the third group (Control group) are going to recieve rutin nursing care interventions. | Other | Control Group |
Primary outcome
Heart Rate change
Time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Heart Rate change before, during and after the intervention
Oxygen Saturation change
Time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Oxygen Saturation change before, during and after the intervention
Respiration Rate change
Time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Respiration Rate change before, during and after the intervention
Body Temperature change
Time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Body Temperature change before, during and after the intervention
Comfort level change
Time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
Premature Infant Comfort Behavior Scale (ComfortNeo) will be used before, during and after the intervention. Each item of this five-point Likert scale is scored from 1 to 5 from bad to good. The baby's comfort is evaluated according to the total score. Accordingly, 30 indicates the lowest and 6 the highest comfort score. A high score on the scale indicates a low level of comfort.
Maternal Attachment
Time frame: 28 days after discharge
Maternal Attachment Scale This scale consists of 26 items and is in 4-point Likert type. "Always" is calculated as 4 points, "often" as 3 points, "sometimes" as 2 points, and "never" as 1 point. An overall score is obtained from the sum of all items. The lowest score to be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment.
Postpartum Depression
Time frame: Before the interventions and 28 days after discharge
Edinburgh Postpartum Depression Scale The scale is in the form of a four-point Likert scale and consists of a total of 10 items. Items 1,2 and 4 are scored as 0,1,2,3 and other items as 3,2,1.0. The lowest possible score is 0 and the highest score is 30.
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 6 Mar 2024.
- Background: PubMed 15827459Rattaz C, Goubet N, Bullinger A. The calming effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2005 Apr;26(2):86-92. doi: 10.1097/00004703-200504000-00003.
- Background: PubMed 34022122Namjoo R, Mehdipour-Rabori R, Bagherian B, Nematollahi M. Comparing the effectiveness of mother's live lullaby and recorded lullaby on physiological responses and sleep of preterm infants: a clinical trial study. J Complement Integr Med. 2021 May 24;19(1):121-129. doi: 10.1515/jcim-2020-0507.
- Background: PubMed 19005869Cignacco E, Hamers JP, van Lingen RA, Zimmermann LJ, Muller R, Gessler P, Nelle M. Pain relief in ventilated preterms during endotracheal suctioning: a randomized controlled trial. Swiss Med Wkly. 2008 Nov 1;138(43-44):635-45. doi: 10.4414/smw.2008.12288.
- Background: PubMed 30721652Lessen Knoll BS, Daramas T, Drake V. Randomized Controlled Trial of a Prefeeding Oral Motor Therapy and Its Effect on Feeding Improvement in a Thai NICU. J Obstet Gynecol Neonatal Nurs. 2019 Mar;48(2):176-188. doi: 10.1016/j.jogn.2019.01.003. Epub 2019 Feb 2.
- Background: PubMed 23703041da Silva CM, Cacao JM, Silva KC, Marques CF, Merey LS. Physiological responses of preterm newborn infants submitted to classical music therapy. Rev Paul Pediatr. 2013 Jan-Mar;31(1):30-6. doi: 10.1590/s0103-05822013000100006. English, Portuguese.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 15205733Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.
- Background: PubMed 31929203Kurt FY, Kucukoglu S, Ozdemir AA, Ozcan Z. The effect of kangaroo care on maternal attachment in preterm infants. Niger J Clin Pract. 2020 Jan;23(1):26-32. doi: 10.4103/njcp.njcp_143_18.
- 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 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 28096005Taheri L, Jahromi MK, Abbasi M, Hojat M. Effect of recorded male lullaby on physiologic response of neonates in NICU. Appl Nurs Res. 2017 Feb;33:127-130. doi: 10.1016/j.apnr.2016.11.003. Epub 2016 Nov 9.
- Individual participant dataSharing planned: No. The researchers have not planned to share any individual participant data yet.
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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 Lullaby group and Breast milk group in people with Preterm and Infant, Premature, Diseases, run by Mustafa Kemal 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 6 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: finished, as of the sponsor's last update on 6 Mar 2024. 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?
Heart Rate change (time frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.). 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 NCT05830955, which also lists 11 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 6 Mar 2024.