Clinical trial NCT06053931: The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort
Official title: The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort During Breastfeeding: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Music
Breastfeeding
Newborn
Mother
Keywords: White noise
Lullaby
neonatal stress
comfort
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 90 mothers and newborns, 30 lullaby, 30 white noise and 30 control groups, will constituted the sample of the study
Primary purpose: PREVENTION

Brief summary: In the literature, music plays an energizing, soothing, stimulating and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby. In addition, it is stated that relaxing music in the early postpartum period supports breastfeeding behaviors of mother and baby. It is stated that lullabies positively affect the newborn's relaxation, falling asleep, and mother-baby communication. however, it facilitates sleep due to its monotonous, emotional and repetitive melody structure, slow tempo and relaxing effect. The sound called white noise is a humming, monotonous and constantly used sound that suppresses the disturbing sounds coming from the environment and has a calming feature. In the literature, it has been found that white noise played to infants with colic reduces crying.

The aim of this study is to determine the effects of lullabies and white noise music played during breastfeeding of the newborn on newborn stress, breastfeeding success and mother's comfort. This study was planned as a randomized controlled trial with term newborns 24 hours after birth.

Detailed description: The hypotheses are presented below;

H1- White noise music played during breastfeeding reduces newborn stress compared to the control group.

H2- White noise music played during breastfeeding increases breastfeeding success compared to the control group.

H3- White noise music played during breastfeeding increases comfort of the mother compared to the control group.

H4- Lullaby music played during breastfeeding reduces newborn stress compared to the control group.

H5- Lullaby music played during breastfeeding increases breastfeeding success compared to the control group.

H6- Lullaby music played during breastfeeding increases comfort of the mother compared to the control group.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age,
* Able to speak Turkish,
* Breastfeeding mothers
* Term and healthy newborn (born at 38-42 weeks, weighing 2500-4000 g, born with an APGAR of 7 or more, without any known congenital disease)

Exclusion Criteria:

* mothers who do not agree to participate in the research
* mother has a condition that prevents breastfeeding

Primary outcomes:
measure: newborn stress level in white noise group
timeFrame: from pre-intervention to 2 minutes after listening to white noise music.
measure: newborn stress level in lullaby group
timeFrame: from pre-intervention to 2 minutes after listening to lullaby.
measure: mother's comfort in white noise group
timeFrame: from pre-intervention to 15 minutes after listening to white noise music
measure: mother's comfort in lullaby group
timeFrame: from pre-intervention to 15 minutes after listening to lullaby.
Secondary outcomes:
measure: breastfeeding success in white noise group
timeFrame: At the 15th minute of breastfeeding
measure: breastfeeding success in lullaby group
timeFrame: At the 15th minute of breastfeeding
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Celal Bayar University
Study officials:
affiliation: Manisa Celal Bayar University
name: Aslı KARAKUŞ SELÇUK, PhD
role: PRINCIPAL_INVESTIGATOR
References: