The Effect of Different Music Listened During Retinopathy Examination to Premature Infants on Their Pain and Comfort Level: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• • Gestational age ≤34 weeks

‣ Birth Weight ≤2000 grams

⁃ Preterm newborns with a corrected/postnatal age of 28-36 weeks at the time of examination

⁃ Having the baby's first ROP examination

⁃ Not giving sedative, opioid and anticonvulsant drugs before/during the examination

⁃ Parents do not have diagnosed mental or mental problems and agree to participate in the research.

Locations
Other Locations
Turkey
Necmettin Erbakan University
RECRUITING
Konya
Contact Information
Primary
Semra KÖSE, PhD, Asisstant Proffessor
semraak_88@hotmail.com
05433682203
Backup
Gizem Kıvrak
gizemynlc@gmail.conm
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 84
Treatments
Experimental: Experiment 1 (Rainstick)
The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. The rain bar will continue to play during the ROP inspection. The rain stick will be played 25cm away from the baby.
Experimental: Experiment 2 (Music-The Happiest Baby)
During the ROP examination, Dr. Harvery Karp's The Happiest Baby, which consists of only intrauterine sounds, is a group of babies who are listened to. The experimental group will start playing music 3 minutes before the start of the process. The examination begins with the insertion of the speculum into the eye. The duration of the examination depends on the visibility of the vascularity in the retina and the examination will end with the removal of the speculum from the eye. Music will continue to play during the ROP exam. The voice recorder that will play The Happiest Baby will be placed 25 cm away from the baby. In the study, the music volume will be set as 45-50 decibels.
No_intervention: Control
It is the group of infants who receive routine care during the ROP examination. In the control group, a routine ROP procedure will be performed without any music before, during and after the ROP examination.
Sponsors
Leads: Necmettin Erbakan University

This content was sourced from clinicaltrials.gov