The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

NCT05830955 | Completed

• 1 other identifier: Hatay Mustafa Kemal University
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Infant, Premature, Diseases; Postpartum Depression; Mother-Infant Interaction

Keywords

Premature; Infant; Comfort; Maternal Attachment; Postpartum Depression

Outcome Measures

Primary Outcomes (7)

• Heart Rate change

  Heart Rate change before, during and after the intervention

  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

  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

  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

  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.

  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.

  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.

  Before the interventions and 28 days after discharge

Study Arms (3)

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).

Other: Lullaby group

Breast milk Group

EXPERIMENTAL

The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.

Other: Breast milk group

Control Group

OTHER

The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.

Other: Control group

Interventions

Lullaby group OTHER

The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).

Lullaby Group

Breast milk group OTHER

The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.

Breast milk Group

Control group OTHER

The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.

Control Group

Eligibility Criteria

• Age: 35 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead
• Istanbul University - Cerrahpasa: collaborator
• Yuzuncu Yil University: collaborator
• Van Training and Research Hospital: collaborator

Study Sites (1)

Van Training and Research Hospital

Van, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 15827459 BACKGROUND

• 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.

  PMID: 34022122 BACKGROUND

• 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.

  PMID: 19005869 BACKGROUND

• 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.

  PMID: 30721652 BACKGROUND

• 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.

  PMID: 23703041 BACKGROUND

• 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.

  PMID: 3651732 BACKGROUND

• 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.

  PMID: 15205733 BACKGROUND

• 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.

  PMID: 31929203 BACKGROUND

• 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.

  PMID: 23589814 BACKGROUND

• 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.

  PMID: 23890458 BACKGROUND

• 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.

  PMID: 28096005 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Infant, Premature, Diseases; Depression, Postpartum

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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 Record Dates

• First Submitted: March 15, 2023
• First Posted: April 26, 2023
• Study Start: May 15, 2023
• Primary Completion: March 4, 2024
• Study Completion: March 5, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)