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Completed

NCT Number: NCT07084987

Massage, Tub Bathing, and Sponge Bathing Effects on Neonatal Bilirubin and Comfort

This randomized controlled trial evaluates the effects of massage, tub bathing, and sponge bathing on bilirubin levels, skin integrity, neonatal comfort, and physiological parameters in term newborns undergoing phototherapy

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Newborn Care Phototherapy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bandırma Education and Research Hospital

Bandırma, Balıkesir, 10200, Turkey (Türkiye)

About this study

Term newborns undergoing phototherapy in the neonatal intensive care unit will be randomized into four groups: massage, sponge bath, tub bath, and control. Pre-intervention assessments include vital signs, skin moisture, bilirubin levels, the Neonatal Comfort Behavior Scale, and the Skin Condition Assessment Scale. Post-intervention assessments are conducted at multiple time points. The study investigates whether massage and bathing interventions can improve comfort, maintain skin integrity, and reduce bilirubin levels more effectively than standard care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion newborns (>37 weeks gestation)

  • Receiving phototherapy
  • Stable vital signs
  • Parental consent

Exclusion criteria

  • Congenital anomalies
  • Severe infections or sepsis
  • Parental refusal

Treatment and study plan

neonatal massage

Other

Standardized neonatal massage before phototherapy

Tub Bathing

Other

Tub bath before phototherapy

sponge bath

Other

Sponge (wipe) bath before phototherapy

Primary outcomes

  1. Change in Serum Bilirubin Levels

    Time frame: Baseline, 6 hours, 24 hours after intervention

    Measured in mg/dL using standard laboratory testing

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Effects of Massage, Tub Bathing, and Sponge Bathing on Bilirubin Levels, Skin Barrier, Neonatal Comfort, and Vital Signs: A Randomized Clinical Trial

Acronym: NEO-BATH

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

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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