NCT05253625

The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain

Status unknown NA Last updated 8 March 2022

What this trial tests

NA trial testing Listening to a recorded lullaby. in Neonatal Intensive Care in 93 participants. Status unknown.

Timeline

8 March 2022

Primary endpoint
15 June 2022

30 June 2022

Quick facts

Lead sponsor	Izmir Tinaztepe University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	supportive care
Enrollment	93
Start date	8 March 2022
Primary completion	15 June 2022
Estimated completion	30 June 2022

Drugs / interventions tested

• Listening to a recorded lullaby.

Conditions studied

• Neonatal Intensive Care — all drugs for Neonatal Intensive Care →
• Music Therapy — all drugs for Music Therapy →
• Pain Responses — all drugs for Pain Responses →

Sponsor

Izmir Tinaztepe University

Who can join

Adults 1 Day to 7 Days, any sex, with Neonatal Intensive Care or Music Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. In such cases, newborns may frequently be exposed to repetitive painful interventions (like IV catherization). Pain in the postnatal period can cause physiological, behavioral and metabolic changes, and changes in the functional processing related with somatosensation and pain in the long term. In this context, inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants.

For these reasons, it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological and/or non-pharmacological interventions. In the intrauterine 20th week, the ability to hear begins to form, and in the 26-28th weeks the level to respond to sounds is achieved. Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks. Especially in the 32nd gestational week, preterm newborns begin to develop the ability to distinguish mother's voice from other sounds with regard to rhythm and intonation. Due to this developmental feature of preterm newborns, it is recommended to use the mother's voice in neonatal intensive care units. However, studies on this subject are very limited.

The main goal of care in neonatal intensive care units is to maintain the baby's life and comfort at the highest level, to minimize pain and suffering, and to ensure that it can cope with pain. In the light of all information, it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics. The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units. The participants will be devided in three groups. The first group will listen to the lulliby recorded with the mothers voice, the second group will listen to the the lulliby recorded with the voice of an unfamilliar female, and the third group will not listen to a lulliby. The effects will be measured by using three physiologic parameters (oxygen saturation, heart rate, and respiratory rate) and pain responses (Neonatai Infant Pain Scala) before, during, and after a painful intervention (IV catherization).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.