Clinical trial NCT06630689: Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort
Official title: Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Keywords: hyperbilirubinemia
massage
comfort
newborn
Lead sponsor: Igdir University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2024-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consisted of 3 groups: control group, dry whole body massage group and oily whole body massage group.
Primary purpose: OTHER

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.

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
* Parents' willingness and volunteering to participate in the study constitute the inclusion criteria for the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Newborn Comfort Behavior Scale (COMFORTneo)
timeFrame: 9 months
measure: Numerical Assessment Scales
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iğdır
country: Turkey
facility: Igdir University
state: Merkez
Study officials:
affiliation: Igdir University
name: meral güven
role: PRINCIPAL_INVESTIGATOR
References: