Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

NCT ID: NCT07016984

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-10

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.

Detailed Description

Retinopathy of prematurity is a pathological condition affecting the developing retinal blood vessels in low birth weight premature infants and is one of the leading causes of childhood blindness. In recent years, advancements in neonatal intensive care in developing countries such as China, India, and Turkey have increased the survival rates of premature infants, consequently raising the number of infants requiring ROP screening examinations. Health Organization (WHO) recommends conducting the initial ROP examination before the infant is discharged from the hospital. However, ROP screening is a painful and stressful procedure that includes the administration of mydriatic agents, the insertion of a speculum to open the palpebral fissure, and scleral depression to visualize the retinal periphery. These interventions often result in discomfort and distress for the infant. Globally, most newborns admitted to neonatal intensive care units (NICUs) undergo repeated painful procedures. It is well-established that premature infants can perceive pain, and exposure to pain during the early stages of life may lead to long-term neurological consequences. In very preterm infants, early exposure to procedural pain has been associated with impaired cognitive development and reductions in frontal and parietal lobe volumes, brain size, white matter, and subcortical gray matter. Considering the frequency of painful interventions during hospitalization, gaining deeper insight into stress-inducing factors and exploring methods to enhance infant comfort is of great importance. Various non-pharmacological interventions-such as pacifiers, music, and oral sucrose-have been studied for their effectiveness in reducing pain and stress during ROP examinations. However, research evaluating the effect of minimizing light exposure during pupil dilation (mydriasis) is limited. Mydriatic eye drops, used to dilate the pupils for examination, are known to cause light sensitivity and photophobia. It is hypothesized that the increased light sensitivity resulting from pupil dilation before the examination contributes to infant discomfort and stress. Therefore, this study aims to investigate the effect of reducing light exposure-by applying eye patches during the mydriasis process-on the comfort levels of premature infants undergoing ROP screening.

Conditions

Premature; Retinopathy of Prematurity; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

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

Group Type: ACTIVE_COMPARATOR

standard phototherapy eye patches

Intervention Type: OTHER

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

Control Group

During the ROP examination, no eye patching was applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

standard phototherapy eye patches

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Nisantasi University

OTHER

Sponsor Role: lead

Responsible Party

Alev Sivasli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zerrin Cigdem, Associate Professor

Role: STUDY_DIRECTOR

Topkapi University, Istanbul, Turkey

Nurşah B Şamlıer, PhD

Role: PRINCIPAL_INVESTIGATOR

Nisantasi University, Istanbul, Turkey

Locations

Nisantasi University

Sarıyer, İ̇stanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Decision No:2023/44

Identifier Type: -

Identifier Source: org_study_id