By InvitationNot Applicable

Hat-Type Glasses Intervention in Phototherapy-Related Newborns

Turkey (Türkiye)24 participantsStarted 2025-08-20

Plain-language 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.

Who can participate

Age range

0 Days – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion Criteria * Being a term newborn (38-42 gestational weeks) * Having an Apgar score of 7-10 * Being hospitalized in a primary care setting and in a cot bed Exclusion Criteria: * Hospitalization with a diagnosis of pathological jaundice * Presence of congenital anomalies in the newborn * Mothers having a condition that may prevent them from completing the questionnaire (such as language barriers) or having a communication impairment * Parents not wanting their newborn to participate in the study, or wishing to withdraw during the course of the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Newborn Comfort Level

Timeframe: Baseline, 60 minutes, and 24 hours after the start of phototherapy.

Trial details

NCT IDNCT07690930

SponsorKaramanoğlu Mehmetbey University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

View on ClinicalTrials.gov More Neonatal Hyperbilirubinemia trials