CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Lullaby group +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05830955
NCT05830955N/ACompleted

The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns

Mustafa Kemal University·interventional·Posted Apr 26, 2023·Updated Mar 6, 2024

In Brief

A clinical study evaluating Lullaby group, Breast milk group, and 1 other intervention for Preterm and 3 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
202420252026
First PostedApr 26, 2023
Enrollment StartMay 15, 2023
Primary CompletionMar 4, 2024
Study CompletionMar 5, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.2 years ago

Interventions

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.