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Completed

NCT Number: NCT05356273

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

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby massage

Procedure

Starting from the baby's face first, then the abdomen and chest, back, upper extremities and finally the lower extremities were massaged with semi-circular movements, respectively.

Primary outcomes

  1. Bilirubin levels

    Time frame: 72 hours

    decreasing bilirubin levels within intervention times

Secondary outcomes

  1. Stool frequency

    Time frame: 72 hours

    increasing stool frequency within intervention times

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 2, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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