Clinical trial NCT05830955: The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
Official title: The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Infant, Premature, Diseases
Postpartum Depression
Mother-Infant Interaction
Keywords: Premature
Infant
Comfort
Maternal Attachment
Postpartum Depression
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Yuzuncu Yıl University
name: Van Training and Research Hospital
First posted: 2023-04-26
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Heart Rate change
timeFrame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
measure: Oxygen Saturation change
timeFrame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
measure: Respiration Rate change
timeFrame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
measure: Body Temperature change
timeFrame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
measure: Comfort level change
timeFrame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
measure: Maternal Attachment
timeFrame: 28 days after discharge
measure: Postpartum Depression
timeFrame: Before the interventions and 28 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Training and Research Hospital
Study officials:
References:
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