Hat-Type Glasses Intervention in Phototherapy-Related Newborns

NCT07690930 | Enrolling By Invitation

• 1 other identifier: KMU-SBF-HD-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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 Jaundice; Neonatal Hyperbilirubinemia

Keywords

Newborn; Parent; Neonatal jaundice; Comfort; Nurse

Outcome Measures

Primary Outcomes (1)

• Newborn Comfort Level

  Newborn comfort will be assessed using the Neonatal Comfort Behavior Scale. The comfort assessment in the Neonatal Comfort Behavior Scale consists of six parameters: wakefulness, calmness/agitation, respiratory response (assessed only in mechanically ventilated newborns), crying, body movements, facial tension, and muscle tone. In newborns receiving mechanical ventilation, the "Respiratory Response" component is considered, while in those not receiving mechanical ventilation, the "Crying" component is considered. Each parameter is on a five-point Likert scale and is scored between 1 and 5. The comfort assessment in this section is done based on the total score. A minimum of 6 and a maximum of 30 points can be obtained from the NCT. A total score between 6-13 means the newborn is comfortable, and a score between 14-30 means the newborn is not comfortable.Comfort scores will be recorded at baseline, 60 minutes after the start of phototherapy, and at 24 hours of phototherapy.

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

Secondary Outcomes (3)

• Serum Bilirubin Level Monitoring Chart

  Baseline and completion of phototherapy (up to 24 hours)

• PHOTOTHERAPY TRACKING CHART

  At completion of phototherapy (up to 24 hours)

• Parent Satisfaction Scale

  At completion of phototherapy (up to 24 hours)

Study Arms (2)

Hat-with-Goggles Group

EXPERIMENTAL

Newborns receiving phototherapy will use the hat-with-goggles device during phototherapy treatment.

Device: Hat-with-Goggles Eye Protection Device

Active Comparator

NO INTERVENTION

Newborns receiving phototherapy will use the standard eye patch routinely applied during phototherapy.

Interventions

Hat-with-Goggles Eye Protection Device DEVICE

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

Also known as: Standard Eye Patch

Hat-with-Goggles Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Location

Karamanoğlu Mehmetbey Üniversitesi

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, investigators, and outcome assessors will not be blinded to group allocation. However, the statistician responsible for data analysis will be blinded to group assignments until completion of the primary analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Newborns receiving phototherapy for neonatal hyperbilirubinemia will be randomly assigned to either the intervention group (hat-with-goggles) or the control group (standard eye patch). Participants will remain in their assigned group throughout the study, and outcomes including comfort level, bilirubin level, duration of phototherapy, and parental satisfaction will be compared between groups.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 8, 2026
• Study Start: August 20, 2025
• Primary Completion: July 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)