Hat-Type Glasses Intervention in Phototherapy-Related Newborns

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neonatal Hyperbilirubinemia; Neonatal Jaundice
• Intervention / Treatment: Device: Hat-with-Goggles Eye Protection Device

Detailed Description

Population and Sample The population of the study will consist of newborns who are followed in the Neonatal Intensive Care Unit of Karaman Training and Research Hospital and receive phototherapy with a diagnosis of hyperbilirubinemia. The sample of the study will include the infants of parents who meet the inclusion criteria and voluntarily agree to participate in the study. The sample size was calculated using the G*Power 3.1.9.4 program. The results of a study investigating the effect of the smell of breast milk on the comfort level of newborns receiving phototherapy in a neonatal intensive care unit were used as a reference. With a significance level of 0.05, a 95% confidence interval, an effect size of 1.06 and a power of 95%, it was determined that each group should include 20 infants. Considering possible case losses during the research process, the sample size was increased by 12%, and it was planned to include 24 infants in each group.

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 Withdrawal Criteria
• After being included in the study, the newborn receives an additional diagnosis of any disease other than physiological jaundice
• Infants who remain under phototherapy for less than 2 hours Randomization and Blinding Newborns who meet the inclusion criteria will be randomly assigned to two groups: the control group and the intervention group (hat-with-goggles application). Block randomization will be used to allocate participants to the control and intervention groups. Randomization will be stratified according to the variables "bilirubin level" and "sex." The selection of sex as a stratification variable is based on the literature, which reports that male sex is associated with hyperbilirubinemia during the neonatal period . Therefore, the sex variable was included in the stratification. Randomization was performed using the Research Randomizer program.

Data Sources and Data Collection Method The data of the study will be collected using the "Personal Data Collection Form," "Phototherapy Follow-up Chart," "Newborn Comfort Behavior Scale," and the "Parental Satisfaction Scale."

In Data Collection:

• Personal Data Collection Form
• Phototherapy Follow-up Chart
• Newborn Comfort Behavior Scale
• Parental Satisfaction Scale

DATA COLLECTION Hat-Integrated Eye Mask The hat-integrated eye mask is a material produced by combining a newborn beanie-made of 100% cotton and free of allergens-with a phototherapy eye mask. The phototherapy eye mask is made of medical-grade material and includes a neoprene eye pad that blocks 100% of harmful light to the eyes. It is designed to remain securely in place on the head without slipping and features adjustable Velcro straps to prevent displacement. It is manufactured from flexible, soft, latex-free carbon and/or other suitable materials that do not irritate the infant's skin.

The phototherapy eye mask used in the production of the hat-integrated eye mask will have the same technical specifications as the standard phototherapy mask routinely used in the clinic. Neoprene fabric is preferred in these masks because it does not allow the passage of light. In routine clinical use, no redness, allergic reactions, skin irritation, erythema, or itching have been reported. A phototherapy eye mask approved for clinical use by the Ministry of Health will be used. No alternative type of eye mask will be preferred in the production of the hat-integrated eye mask. Technical specifications required for procurement will match those of the standard phototherapy eye mask used in the control group.

Considering risks such as sweating, itching, and redness that may arise with prolonged use, newborns receiving phototherapy inside an incubator were excluded from the study. In line with the anticipated increase in comfort level and maternal satisfaction associated with the hat-integrated eye mask, multidisciplinary studies may support the development of material types specifically tailored for newborns receiving phototherapy in incubators.

Study data will be collected only from infants receiving phototherapy in cot beds. The hat-integrated eye masks will be produced by a tailor outside the hospital. All materials used in production will be chosen to allow sterilization. Accordingly, each hat-integrated eye mask must be sterilized before being applied to newborns for infection control purposes. The masks will be single-use only and will not be re-sterilized after use. The sterilization process will be conducted before application, and the masks will be discarded after the infant is discharged.

Intervention Group Newborns in the intervention group will be fitted with a hat-integrated eye mask. This hat-integrated eye mask is designed to prevent the phototherapy goggles from slipping during phototherapy and consists of a hat combined with an eye band. The application aims to prevent retinal damage that may occur in the newborn's eyes due to phototherapy light, and by reducing the effect of light passing through the head region on the pineal gland, it supports maintaining melatonin levels and increasing comfort.

For newborns in the intervention group, before applying the hat-integrated eye mask during hospital admission, they will be placed in an open crib and their vital signs will be assessed using a pulse oximeter. To prepare the newborn for phototherapy, clothing will be removed, the cleanliness of the diaper will be ensured, and the saturation probe will be attached. Afterward, the hat-with-goggles will be placed on the newborn, and phototherapy will be initiated. Vital signs will be assessed while the newborn is in the mother's arms before phototherapy, at minute 0 (immediately before starting phototherapy), at the 60th minute, and at the 24th hour. Newborn comfort behaviors will be assessed at these same time points by two experts.

According to the literature, newborns require 14-17 hours of sleep per day, which is divided into 4 or 5 periods. Each period includes awake intervals of 40-80 minutes. Considering this information, the variability of phototherapy duration among newborns, and the working principles of the clinic, the timing of vital sign assessments and comfort measurements was determined as before phototherapy in the mother's arms, at minute 0 (immediately before phototherapy), at the 60th minute, and at the 24th hour.

The time and reasons for discontinuation of phototherapy will be recorded by the researcher during the phototherapy process. The satisfaction levels of mothers in the intervention group will be evaluated after phototherapy (when phototherapy is discontinued).

________________________________________ Control Group Newborns in the control group will wear the standard phototherapy eye mask routinely used in the clinic. For newborns in this group, before placing the standard eye mask during hospital admission, they will be placed in an open crib and their vital signs will be assessed using a pulse oximeter. To prepare the newborn for phototherapy, clothing will be removed, the cleanliness of the diaper will be checked, and the saturation probe will be placed. Then, the routine phototherapy eye mask will be applied, and phototherapy will begin.

Vital signs will be assessed before phototherapy, at the 60th minute, and at the 24th hour. Newborn comfort behaviors will be assessed by two experts before phototherapy in the mother's arms, at the initiation of phototherapy, at the 60th minute, and at the 24th hour. The time and reasons for discontinuation of phototherapy will be recorded by the researcher during the phototherapy procedure. The satisfaction levels of mothers in the control group will also be evaluated after phototherapy (when phototherapy is discontinued).

Data Analysis The statistical analysis of the study will be conducted using IBM SPSS Statistics Version 23, with a significance level of p<0.05. The normality of data distribution will be assessed using the Shapiro-Wilk test. Parametric analyses (t-test and ANOVA) will be performed for normally distributed data, whereas non-parametric analyses (Mann-Whitney U and Kruskal-Wallis tests) will be used for data not meeting normality assumptions. Repeated measures will be analyzed using analysis of variance. Cohen's Kappa analysis will be used to evaluate inter-rater agreement between the two observers. Analysis results will be presented as mean, standard deviation, and median (1st and 3rd quartiles) for quantitative data, and as frequency (percentage) for categorical data.

________________________________________ Ethical Considerations To conduct the study, permission to use the scales-previously validated and tested for reliability in Turkish-will first be obtained from the original authors via email. Mothers of newborns who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained from those who agree to participate. Since the study involves human subjects, the ethical principles of "Informed Consent," "Voluntariness," and "Confidentiality" will be strictly observed. Ethical approval for the study will be obtained from the Scientific Research and Publication Ethics Committee of Karamanoğlu Mehmetbey University, Faculty of Health Sciences. Additionally, institutional permission will be obtained to conduct the study in the Neonatal Intensive Care Unit of Karaman Training and Research Hospital.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Karaman, Turkey (Türkiye)
    • Karaman Training and Research Hospital
  • Karaman, Turkey (Türkiye)
    • Karamanoğlu Mehmetbey Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hat-with-Goggles Group; Newborns receiving phototherapy will use the hat-with-goggles device during phototherapy treatment.	Device: Hat-with-Goggles Eye Protection Device; The conventional eye patch routinely used during phototherapy in newborns with hyperbilirubinemia.; Other Names: Standard Eye Patch
No Intervention: Active Comparator; Newborns receiving phototherapy will use the standard eye patch routinely applied during phototherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Bilirubin Level Monitoring Chart	Measurement of serum bilirubin levels during phototherapy treatment.Serum bilirubin levels of newborns will be measured during phototherapy treatment. Changes (decreases/increases) in these measurements will be monitored. Changes in serum bilirubin levels will be statistically compared between the group receiving glasses and the control group.	Baseline and completion of phototherapy (up to 24 hours)
PHOTOTHERAPY TRACKING CHART	The duration of phototherapy treatment will be recorded in hours, and this output will be considered the total phototherapy time. Interruptions to phototherapy will be deducted from the total time. Reasons for interruptions will be recorded. Phototherapy duration will be statistically compared between the group using glasses and a control group. A decrease in phototherapy duration is expected in cases of better compliance with phototherapy and less discontinuation.	At completion of phototherapy (up to 24 hours)
Parent Satisfaction Scale	Parental satisfaction with the eye protection method used during phototherapy (eye mask/routine application) will be evaluated (for reasons such as the newborn's eye mask coming off their eyes or the newborn becoming restless during phototherapy). The evaluation will be done using a scale of 1-10, where 1 indicates low satisfaction and 10 indicates high satisfaction.	At completion of phototherapy (up to 24 hours)

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Collaborators: The Scientific and Technological Research Council of Turkey

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Nurse; Newborn; Parent; Comfort; Neonatal jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: KMU-SBF-HD-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include permission for public data sharing, and data confidentiality and participant privacy will be maintained in accordance with institutional and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No