Infant, Premature, Diseases, Mother-Infant Interaction, Postpartum Depression, Preterm
Conditions
Keywords
Premature, Infant, Comfort, Maternal Attachment, Postpartum Depression
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.
Interventions
OTHERLullaby group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
OTHERBreast milk group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
OTHERControl group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Sponsors
Istanbul University - Cerrahpasa
Yuzuncu Yil University
Van Training and Research Hospital
Mustafa Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
35 Weeks to 37 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Depression | 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 | 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 |
| Oxygen Saturation change | 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 | 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 |
| Body Temperature change | 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 | 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. |
| Maternal Attachment | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed