The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Lullaby group
* Other: Breast milk group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate change | Heart Rate change before, during and after the intervention | 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 | Oxygen Saturation change before, during and after the intervention | 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 | Respiration Rate change before, during and after the intervention | 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 | Body Temperature change before, during and after the intervention | 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days. | 
| Comfort level change | 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. | 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days | 
| Maternal Attachment | 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. | 28 days after discharge | 
| Postpartum Depression | 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. | Before the interventions and 28 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression