The effect of ocean sound on physiological parameters, pain and comfort level in premature retinopathy examination: A randomized controlled study

This study was carried out in a single-blind, parallel group, randomized controlled experimental design in order to determine the effect of the ocean sound listened to during the retinopathy of prematurity examination in the Neonatal Intensive Care Unit, on pain, comfort and physiological parameters. The study was carried out in the Neonatal Intensive Care Unit of a University Hospital in Konya between March 2021 and June 2023. Stratified randomization method was used in sample selection, and a total of 44 premature babies, including intervention (n:21) and control (n:23), were included in the study. Premature babies in the intervention group were started to listen to the ocean sound 1 minute before the ROP examination, and the ocean sound was turned off at the 5th minute after the procedure. The control group was not listened to any sound. The ROP examination was video-recorded and the images were examined by two blind observers, other than the researchers, and pain and comfort assessments of the premature babies were made 2 minutes before, 1 minute and 5 minutes after the procedure. Data were collected with Infant Information Form, Physiological Parameter Follow-up Form, Premature Infant Pain Profile Scale-Revised Form (PIPP-R), Premature Infant Comfort Scale (PBIC). In the analysis of data, in addition to descriptive statistics, Chi-square Test, Mann Whitney U Test in independent groups, Wilcoxon Signed Ranks Test in dependent groups and Friedman Test in repeated measurements, intraclass correlation coefficient analysis (ICC-Intraclass Correlation Coefficent) in evaluating the agreement between observers, and in the evaluation of effect size. Cohen d and 95% confidence intervals were used. The pain levels of the premature babies in the intervention and control groups at the 1st minute (9,40±2,45; 8,34±2,64) and the pain levels at the 5th minute (6,14±2,94; 5,19±3,67) and there was no statistically significant difference between the groups (p>0.05). In the evaluation of comfort level, it was determined that there was no significant difference between the comfort score averages of the intervention and control groups at the 1st and 5th minutes after the procedure (p>0.05). Heart rate and oxygen saturation parameters were stabilized in both groups, but the difference was not significant between the groups (p>0.05). As a result, it was found that only listening to the sound of the ocean during the ROP examination did not have a significant effect on pain, comfort and physiological parameters in premature babies. Further studies examining the effectiveness of listening to the ocean sound in the ROP examination and comparing it with different musical interventions are recommended. This study is registered in the Clinical Trials database (NCT05203159). Keywords: Pain, Nurse, Premature infant, Retinopathy of prematurity, Neonatal intensive care.