White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns

NCT ID: NCT06209489

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-06-30

Brief Summary

This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.

Detailed Description

Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.

Conditions

Newborn Jaundice; Hyperbilirubinemia, Neonatal; Newborn Massage; Phototerapy; White Cover

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

İntervention group

1. White fabric will be covered over the incubator for term newborns during phototherapy.

2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes.

Group Type: EXPERIMENTAL

White cover

Intervention Type: OTHER

• A white cover will be covered over the incubator during phototherapy.
• Baby massage will be applied during phototherapy.

Control group

The hospital's clinical routine will be applied to the newborns in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

White cover

• A white cover will be covered over the incubator during phototherapy.
• Baby massage will be applied during phototherapy.

Intervention Type: OTHER

Other Intervention Names

Newborn massage

Eligibility Criteria

Inclusion Criteria

• Term babies with gestational age between 37-42 weeks,
• Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
• Birth weight of 2500 g and above,
• With phototherapy indication,
• Do not have any health problems other than neonatal jaundice detected in the prenatal period,
• Those with a stable health condition,
• Orally fed,
• No clinical signs of dehydration,
• Do not have any skin problems that would prevent baby massage,
• Newborns with written and verbal informed consent from their families will be included in the study.

Exclusion Criteria

• Premature,
• Those with congenital malformations,
• Those with hyperbilirubinemia requiring exchange transfusion,
• Those with Rh hemolytic disease,
• Having a positive culture test (sepsis),
• Those with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
• Birth weight below 2500 grams,
• Those who were referred to another center during the research,
• Discharged early,
• Unexpected complications developed during the research,
• Bronze child syndrome occurs during phototherapy,
• Newborns who develop a pathology that will prevent or complicate oral feeding will not be included in the study.

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karabuk University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep ÇİFTCİ DEMİRTAŞ

Midwife

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep ZE ÇİFTCİ DEMİRTAŞ, 1

Role: PRINCIPAL_INVESTIGATOR

midwife

Locations

Karabuk University

Karabük, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-77192459-050.99-299327

Identifier Type: -

Identifier Source: org_study_id