Status:
COMPLETED
Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants
Lead Sponsor:
Istanbul Medeniyet University
Conditions:
Premature Infant
Retinopaty of Prematurity
Eligibility:
All Genders
26-32 years
Phase:
NA
Brief Summary
This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).
Detailed Description
Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the applic...
Eligibility Criteria
Inclusion
- Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
- Stable, awake, in supine position and breathing spontaneously without oxygen support,
- Vital signs were within normal limits before the examination,
- Premature infants undergoing ROP examination for the first time.
Exclusion
- Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
- Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
- Preterms with critical conditions such as central nervous system infections and sepsis,
- Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
- Preterms with congenital malformations.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06959290
Start Date
May 1 2025
End Date
June 30 2025
Last Update
July 14 2025
Active Locations (1)
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1
Istanbul Medeniyet University
Istanbul, Istanbul, Turkey (Türkiye), 34862