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Clinical Trials/NCT05830955
NCT05830955
Completed
Not Applicable

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

Mustafa Kemal University1 site in 1 country57 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm
Sponsor
Mustafa Kemal University
Enrollment
57
Locations
1
Primary Endpoint
Maternal Attachment
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
March 5, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gizem Kerimoğlu Yıldız

Assistant Professor

Mustafa Kemal University

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

Outcomes

Primary Outcomes

Maternal Attachment

Time Frame: 28 days after discharge

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

Time Frame: Before the interventions and 28 days after discharge

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.

Heart Rate change

Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.

Heart Rate change before, during and after the intervention

Body Temperature change

Time Frame: 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 before, during and after the intervention

Comfort level change

Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days

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.

Oxygen Saturation change

Time Frame: 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 before, during and after the intervention

Respiration Rate change

Time Frame: 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 before, during and after the intervention

Study Sites (1)

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