The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
NCT ID: NCT05830955
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2023-05-15
2024-03-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Lullaby Group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Lullaby group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Breast milk Group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Breast milk group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Control Group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Control group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Interventions
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Lullaby group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Breast milk group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Control group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
35 Weeks
37 Weeks
ALL
Yes
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Yuzuncu Yıl University
OTHER
Van Training and Research Hospital
OTHER_GOV
Mustafa Kemal University
OTHER
Responsible Party
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Gizem Kerimoğlu Yıldız
Assistant Professor
Locations
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Van Training and Research Hospital
Van, , Turkey (Türkiye)
Countries
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References
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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.
Namjoo 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.
Cignacco 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.
Lessen 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.
da 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.
Cox 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.
Aydin 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.
Kurt 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.
Loewy 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.
Alipour 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.
Taheri 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.
Other Identifiers
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Hatay Mustafa Kemal University
Identifier Type: -
Identifier Source: org_study_id
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