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

NCT05967572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-01-24

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity
  • Newborn

Interventions

OTHER

Research processes;

1. Before Inspection: information will be obtained and premature babies will be monitored by wearing a pulse oximeter device and their heart rate and oxygen saturation value will be recorded for control purposes. By making video recordings of each premature baby; PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded 3 minutes before the ROP examination. Babies will be fed and changed at least half an hour before the examination. 2. Inspection Sequence: PIPP pain score, PBIC comfort score, control oxygen saturation and peak heart rate values will be recorded and evaluated from the video recording that continues with the start of the examination. 3. End of Inspection: Infants whose both eye examinations are completed and whose monitoring and video recording continue will be recorded and evaluated 3 minutes after the end of the examination, with PIPP pain score, PBIC comfort score, control oxygen saturation and heart rate values.

Sponsors & Collaborators

  • Necmettin Erbakan University

    lead OTHER

Principal Investigators

  • Semra KÖSE · Necmettin Erbakan University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-03-01
Completion
2024-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

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View NCT05967572 on ClinicalTrials.gov