Clinical trial NCT05356273: The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Official title: The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Keywords: infant
baby massage
hyperbilirubinemia
bilirubin
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 61
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy.

Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.


Eligibility criteria: Inclusion Criteria:

* Born between 37-42 gestational weeks
* Birth weight between 2500-4000gr
* 1st and 5th Apgar score between 7-10
* Needing phototherapy treatment
* Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
* Orally fed
* No health problems other than indirect hyperbilirubinemia
* Newborns who has stable vital signs

Exclusion Criteria:

* ABO blood incompatibility or Rh incompatibility
* Diagnosed with direct hyperbilirubinemia
* Newborns who has skin anomaly
* Needing fluid replacement
* Newborns with gastrointestinal disorders

Primary outcomes:
measure: Bilirubin levels
timeFrame: 72 hours
Secondary outcomes:
measure: Stool frequency
timeFrame: 72 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Researcher Assistant
name: Elif Dogan
role: PRINCIPAL_INVESTIGATOR
References:
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