The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

Sponsor

Mustafa Kemal University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05830955

Collaborator

Istanbul University - Cerrahpasa (IUC) (Other), Yuzuncu Yıl University (Other), Van Training and Research Hospital (Other)

Enrollment

Arms

18.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Infant, Premature, Diseases Postpartum Depression Mother-Infant Interaction	Other: Lullaby group Other: Breast milk group Other: Control group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Lullaby Group

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

The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).

Experimental: Breast milk Group

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

Other: Breast milk group

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

Other: Control Group

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

Other: Control group

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

Outcome Measures

Primary Outcome Measures

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.
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.