NCT05828420

The Effect of Music, White Noise and Heart Sound on Neonatal Pain

Completed NA Last updated 25 April 2023

What this trial tests

NA trial testing White noise in Neonatal in 84 participants. Completed in 27 February 2023.

Timeline

1 October 2020

Primary endpoint
30 January 2021

27 February 2023

Quick facts

Lead sponsor	Istanbul University - Cerrahpasa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	supportive care
Enrollment	84
Start date	1 October 2020
Primary completion	30 January 2021
Estimated completion	27 February 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• White noise
• Heart sound
• Music

Conditions studied

• Neonatal — all drugs for Neonatal →
• Pain — all drugs for Pain →

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 1 Day to 30 Days, any sex, with Neonatal or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization.

The most significant problem encountered in understanding pain in infants is the lack of verbal expression of pain. Newborns express their pain with nonverbal behavioral expressions. Therefore, any pain assessment is based on the ability to recognize the pain symptoms of others. The pain experienced may cause physiological imbalances and abnormalities in brain development and stress response in infants in the short and long term. It can negatively affect family-infant communication, as well as cause emotional and psychosomatic problems later in life.

Today, music therapy has positive effects on reducing stress, reducing pain, oxygen saturation level, and peak heart rate values in providing individualized developmental care of the infant in neonatal intensive care units. Heart sound, babies hear the mother's heart sound the most during the intrauterine period in the womb. Therefore, when babies hear the sound, they are familiar with in the womb, they will feel safe and a sense of relaxation will occur in the baby. Several studies have proven that playing heartbeat sounds to newborn babies can positively affect their physiological indicators, feeding, length of hospital stay and pain outcomes. The current literature shows that the presence of rhythmic sound can positively affect the neurobehavioral development of the infant and reduce pain. Rhythmic sounds have healing/positive effects on newborns; listening to white noise reduces preterms' pain scores, stabilizes vital signs, and plays an active role in preterms' sleep-wake period.

In line with all this information, this study was carried out as a randomized controlled experimental study in order to determine the effects of music played during heel spear application, white noise and heart sound in infants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.