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Hat-Type Glasses Intervention in Phototherapy-Related Newborns

NCT07690930 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-05

No results posted yet for this study

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.

Conditions

  • Neonatal Hyperbilirubinemia
  • Neonatal Jaundice

Interventions

DEVICE

Hat-with-Goggles Eye Protection Device

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

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • Karamanoğlu Mehmetbey University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-07-15
Completion
2026-08-30

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT07690930 on ClinicalTrials.gov