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NCT Number: NCT05830955

The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

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.

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Key information

Conditions

Preterm Congenital, Hereditary, and Neonatal Diseases and Abnormalities Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Mental Disorders Mood Disorders Mother-Infant Interaction Obstetric Labor Complications Obstetric Labor, Premature Postpartum Depression Pregnancy Complications Premature Birth Puerperal Disorders Urogenital Diseases

Age range

35 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Training and Research Hospital

Van, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Breast milk group

Other

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

Control Group

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Collaborators

  • Istanbul University - Cerrahpasa
  • Van Training and Research Hospital
  • Yuzuncu Yil University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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