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Clinical Trials/NCT05356273
NCT05356273CompletedNot Applicable

The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy

Istanbul University - Cerrahpasa (IUC)1 site in 1 country61 target enrollmentStarted: October 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
61
Locations
1
Primary Endpoint
Bilirubin levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Bilirubin levels

Time Frame: 72 hours

decreasing bilirubin levels within intervention times

Secondary Outcomes

  • Stool frequency(72 hours)

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Dogan

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Study Sites (1)

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