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Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

NCT07016984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-12

No results posted yet for this study

Summary

Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. This study aimed to investigate the effect of using a phototherapy eye mask during mydriasis on the comfort levels of premature infants.

Conditions

  • Premature
  • Retinopathy of Prematurity
  • Pain

Interventions

OTHER

standard phototherapy eye patches

Following the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches.

Sponsors & Collaborators

  • Istanbul Nisantasi University

    lead OTHER

Principal Investigators

  • Zerrin Cigdem, Associate Professor · Topkapi University, Istanbul, Turkey

  • Nurşah B Şamlıer, PhD · Nisantasi University, Istanbul, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-02-28
Completion
2025-03-10

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016984 on ClinicalTrials.gov