Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort

NCT ID: NCT06630689

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-08-31

Brief Summary

The need for infant massage may come to the forefront as a part of routine care in the neonatal intensive care unit to reduce high bilirubin levels in newborns and to reduce the need for phototherapy treatment. This study was planned to investigate the effects of oily and dry neonatal massage on hyperbilirubinemia and comfort.

Detailed Description

Hyperbilirubinemia is a common disease affecting newborns. It is a self-limiting condition, but if not properly monitored and managed, it can cause permanent neurological disorders. Hyperbilirubinemia affects approximately 8-11% of newborns and accounts for 75% of hospitalizations in the first weeks of life. Physiological jaundice occurs in newborns within the first 24-72 hours after birth; it is at its highest level on days 3-4, begins to decrease on days 5-7 and disappears completely on days 10-14, and in premature babies, it occurs after 48 hours and can take up to 4 weeks to completely resolve. Jaundice that occurs within the first 24 hours is pathological jaundice. High bilirubin levels can cause kernicterus, which can lead to serious neurological damage if not diagnosed and treated early. This condition has a 75% probability of death in infants and can cause neurological sequelae in 80% of survivors. Different treatment methods are used to reduce bilirubin levels. Frequently used methods are; exchange transfusion, phototherapy and drug therapy. Phototherapy is one of the most frequently used methods in the treatment of hyperbilirubinemia. Phototherapy has many complications such as damage to the retina and reproductive organs, dehydration in the body, skin rashes, watery stools and bronze baby syndrome. Recently, research has been conducted on different treatment approaches and new applications to manage neonatal hyperbilirubinemia and shorten the hospitalization period. It has been stated that massage and bath applications reduce bilirubin levels in newborns. Massage is the systematic manual stimulation of the soft tissues of the body with movements such as friction, pressing, rolling and touching for therapeutic purposes. Massage, which is one of the oldest healing applications and can be easily applied together with traditional treatments, is the most natural and instinctive tools.Massage in newborns is accepted as a new care method with positive effects.Neonatal massage is not a mechanical routine, but a simple, cheap and effective technique to support newborn development and to ensure that parents establish eye contact with their babies. Massage is a new, easy to apply and alternative method that can be used to reduce bilirubin levels in newborns. Baby massage can help to remove bilirubin from the body by increasing lymph and blood circulation. Massage stimulates bowel movements and causes early defecation. Increased intestinal peristalsis reduces the enterohepatic circulation of bilirubin and accelerates its excretion from the body. Studies have shown that massage significantly increases the frequency of defecation in babies. Baby massage can significantly increase the number of stools by significantly increasing the intestinal stimulation of babies with vagal activity and thus help to remove bilirubin from the body. In the findings of many studies; it has been reported that baby massage is a method that helps to remove bilirubin from the body.

Conditions

Hyperbilirubinemia, Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

control group

Babies in the control group will receive treatment and care according to neonatal intensive care unit procedures. No intervention will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dry Full Body Massage Group

Unlike the control group, dry whole body massage was applied to the babies who were followed up after completing the phototherapy treatment process.

Group Type: EXPERIMENTAL

Dry Full Body Massage

Intervention Type: OTHER

Applying massage after phototherapy

Oil Full Body Massage Group

Unlike the control group, the babies in this group received a full body oil massage. The full body oil massage was applied using pure baby olive oil.

Group Type: EXPERIMENTAL

Oil Full Body Massage

Intervention Type: OTHER

Oil Full Body Massage

Interventions

Dry Full Body Massage

Applying massage after phototherapy

Intervention Type: OTHER

Oil Full Body Massage

Oil Full Body Massage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being a term (37-42 weeks) newborn.
• The newborn's postnatal age is between 1st and 28th days
• The 1st and 5th Apgar score is between 7-10
• The newborn is fed orally
• The newborn's birth weight is 2500 grams and above
• Phototherapy treatment is terminated and followed up
• Receiving nutritional support for hyperbilirubinemia
• No health problems other than hyperbilirubinemia
• Stable general health status

Exclusion Criteria

-

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

meral güven

OTHER

Sponsor Role: lead

Responsible Party

meral güven

research assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

meral güven

Role: PRINCIPAL_INVESTIGATOR

Igdir University

Locations

Igdir University

Iğdır, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IU-SBF-MG-01

Identifier Type: -

Identifier Source: org_study_id