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ENROLLING BY INVITATION
NCT07690930
NA

Hat-Type Glasses Intervention in Phototherapy-Related Newborns

Sponsor: Karamanoğlu Mehmetbey University

View on ClinicalTrials.gov

Summary

Aim : "This study aims to determine the effect of using a cap with protective eye goggles in term newborns undergoing phototherapy on the duration of phototherapy, the newborns' comfort level, and parental satisfaction." Study Design: This study has a randomized controlled, single-blind experimental design. Variables of the Study Dependent variables: Pulse and saturation values, Newborn Comfort Behavior Scale Score, bilirubin level, parental satisfaction level, duration of phototherapy. Independent variables: Demographic variables related to parents and newborns, the hat-with-goggles intervention. Limitations of the Study * The fact that the study data were collected from a single center constitutes a limitation. * The hat-with-goggles intervention can only be applied to infants in primary care settings and those placed in cot beds, which represents another limitation. 4.2. Research Question and Hypotheses H1.1: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on newborns' comfort levels. H1.2: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on newborns' bilirubin levels. H1.3: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on the duration of phototherapy. H1.4: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on parental satisfaction levels.

Official title: The Effect of the Hat-Type Glasses Intervention Used in Phototherapy on Phototherapy Stay Duration, Comfort Level, and Parental Satisfaction

Key Details

Gender

All

Age Range

0 Days - 28 Days

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-20

Completion Date

2026-08-30

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DEVICE

Hat-with-Goggles Eye Protection Device

The conventional eye patch routinely used during phototherapy in newborns with hyperbilirubinemia.

Locations (2)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Karamanoğlu Mehmetbey Üniversitesi

Karaman, Turkey (Türkiye)