NCT05967572

The Effect of Different Music Listened During Retinopathy Examination to Premature Infants

Status unknown NA Last updated 24 January 2024

What this trial tests

NA trial testing Research processes; in Retinopathy of Prematurity in 84 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
1 March 2024

1 July 2024

Quick facts

Lead sponsor	Necmettin Erbakan University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	84
Start date	1 June 2023
Primary completion	1 March 2024
Estimated completion	1 July 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Research processes;

Conditions studied

• Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
• Newborn — all drugs for Newborn →

Sponsor

Necmettin Erbakan University

Who can join

Adults 28 Weeks to 36 Weeks, any sex, with Retinopathy of Prematurity or Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Retinopathy of Prematurity (ROP); It is a disease of premature and low birth weight infants, characterized by incomplete vascularization of the retina, etiology and pathogenesis of which is unknown, and causes vision loss. There is an increase in the incidence and severity of ROP development in direct proportion to the decrease in birth week and birth weight. While ROP is a problem below 32 weeks of gestation in developed countries, it is reported to develop severely up to 34 weeks of gestation in developing countries. In a multicenter study conducted by the Turkish Neonatology Society in our country, the frequency of ROP in very low birth weight preterm infants was found to be 42%, and the frequency of advanced ROP was 11%. The incidence of ROP in babies with a gestational age of 33-35 weeks was 6.1%, and advanced ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in babies with a birth weight of 1500-2000 grams, and severe ROP was reported in 19 of these babies. ROP examination is a procedure that causes pain, deterioration in comfort and physiological changes in preterm newborns. After this examination, an increase in blood pressure and heart rate and a decrease in oxygen saturation are observed. Pharmacological and non-pharmacological (non-pharmacological) methods are used to reduce the pain and increase the comfort level of the premature newborn. As a pharmacological method, there is no other routine method used to reduce pain other than the administration of local anesthetic drops before the examination. Because of this situation, nurses apply various non-pharmacological methods to alleviate pain. These methods are; breast milk, sucrose use, oral dextrose use, non-nutritive sucking, positioning, listening to music and mother's voice. In the literature, no specific study was found in which music was used to reduce pain and increase the comfort level during the ROP examination. Therefore, this research will be carried out to determine the effect of different music played on the pain and comfort level of premature babies during the retinopathy examination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.