ClinicalTrials.Veeva

Menu

The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

M

Mustafa Kemal University

Status

Completed

Conditions

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

Treatments

Other: Breast milk group
Other: Lullaby group
Other: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT05830955
Hatay Mustafa Kemal University

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

35 to 37 weeks old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

57 participants in 3 patient groups

Lullaby Group
Experimental group
Description:
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Treatment:
Other: Lullaby group
Breast milk Group
Experimental group
Description:
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Treatment:
Other: Breast milk group
Control Group
Other group
Description:
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Treatment:
Other: Control group

Trial contacts and locations

1

Loading...

Central trial contact

Birsen Mutlu, PhD; Gizem Kerimoglu Yildiz, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems