Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

NCT07016984 | Completed

• 1 other identifier: Decision No:2023/44
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infant comfort; Light Exposure; Mydriasis; Non-pharmacological intervention; Neonatal intensive care; Premature infants; Retinopathy of prematurity

Outcome Measures

Primary Outcomes (1)

• post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups

  Statistically significant differences were observed in the total scores and all subdimensions of the PICS-alertness, calmness/agitation, crying (in non-ventilated infants), physical movement, muscle tone, facial movements, and average heart rate

  8 hours

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

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

Other: standard phototherapy eye patches

Control Group

NO INTERVENTION

During the ROP examination, no eye patching was applied.

Interventions

standard phototherapy eye patches OTHER

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

Experimental Group

Eligibility Criteria

• Age: 21 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age ≤34 weeks
• Birth weight ≤1700 grams
• Parental consent to participate in the study

You may not qualify if:

• Required mechanical ventilation during the study period
• Had genetic disorders, heart disease, neurological or metabolic conditions, pulmonary anomalies, or ocular malformations
• Had any conditions affecting the stress response
• Were administered sedatives, muscle relaxants, corticosteroids, or analgesics
• Had major congenital anomalies

Sponsors & Collaborators

• Istanbul Nisantasi University: lead

Study Sites (1)

Nisantasi University

Sarıyer, İ̇stanbul, 34481742, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Retinopathy of Prematurity; Pain; Mydriasis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pupil Disorders

Study Officials

• Zerrin Cigdem, Associate Professor

  Topkapi University, Istanbul, Turkey

  STUDY DIRECTOR

• Nurşah B Şamlıer, PhD

  Nisantasi University, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 12, 2025
• Study Start: January 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 10, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)