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The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

Primary Purpose

Preterm, Infant, Premature, Diseases, Postpartum Depression

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lullaby group
Breast milk group
Control group
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression

Eligibility Criteria

35 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Van Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Lullaby Group

Breast milk Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart Rate change
Heart Rate change before, during and after the intervention
Oxygen Saturation change
Oxygen Saturation change before, during and after the intervention
Respiration Rate change
Respiration Rate change before, during and after the intervention
Body Temperature change
Body Temperature change before, during and after the intervention
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
October 17, 2023
Sponsor
Mustafa Kemal University
Collaborators
Istanbul University - Cerrahpasa (IUC), Yuzuncu Yıl University, Van Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05830955
Brief Title
The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
Official Title
The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
Collaborators
Istanbul University - Cerrahpasa (IUC), Yuzuncu Yıl University, Van Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Infant, Premature, Diseases, Postpartum Depression, Mother-Infant Interaction
Keywords
Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lullaby Group
Arm Type
Experimental
Arm Description
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Arm Title
Breast milk Group
Arm Type
Experimental
Arm Description
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Arm Title
Control Group
Arm Type
Other
Arm Description
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Intervention Type
Other
Intervention Name(s)
Lullaby group
Intervention Description
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Intervention Type
Other
Intervention Name(s)
Breast milk group
Intervention Description
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Primary Outcome Measure Information:
Title
Heart Rate change
Description
Heart Rate change before, during and after the intervention
Time Frame
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Title
Oxygen Saturation change
Description
Oxygen Saturation change before, during and after the intervention
Time Frame
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Title
Respiration Rate change
Description
Respiration Rate change before, during and after the intervention
Time Frame
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Title
Body Temperature change
Description
Body Temperature change before, during and after the intervention
Time Frame
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Title
Comfort level change
Description
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.
Time Frame
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
Title
Maternal Attachment
Description
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.
Time Frame
28 days after discharge
Title
Postpartum Depression
Description
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.
Time Frame
Before the interventions and 28 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gizem Kerimoglu Yildiz, PhD
Phone
+905378659476
Email
gizemkerimogluyildiz@mku.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Birsen Mutlu, PhD
Email
bdonmez@istanbul.edu.tr
Facility Information:
Facility Name
Van Training and Research Hospital
City
Van
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rıdvan Akdogan, MSc
Phone
05413983680
Email
ridvanakdogan30@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The researchers have not planned to share any individual participant data yet.
Citations:
PubMed Identifier
15827459
Citation
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.
Results Reference
background
PubMed Identifier
34022122
Citation
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.
Results Reference
background
PubMed Identifier
19005869
Citation
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.
Results Reference
background
PubMed Identifier
30721652
Citation
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.
Results Reference
background
PubMed Identifier
23703041
Citation
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.
Results Reference
background
PubMed Identifier
3651732
Citation
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.
Results Reference
background
PubMed Identifier
15205733
Citation
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.
Results Reference
background
PubMed Identifier
31929203
Citation
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.
Results Reference
background
PubMed Identifier
23589814
Citation
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.
Results Reference
background
PubMed Identifier
23890458
Citation
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.
Results Reference
background
PubMed Identifier
28096005
Citation
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.
Results Reference
background

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The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

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