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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07084987

Acronym

NEO-BATH

Enrollment

120

Registered

2025-07-25

Start date

2021-09-01

Completion date

2024-08-01

Last updated

2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hyperbilirubinemia, Newborn Care Phototherapy

Keywords

Neonatal Hyperbilirubinemia, Phototherapy, Neonatal Massage

Brief summary

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

Detailed description

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.

Interventions

OTHERneonatal massage

Standardized neonatal massage before phototherapy

OTHERTub Bathing

Tub bath before phototherapy

OTHERsponge bath

Sponge (wipe) bath before phototherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Masking description

The study is open-label due to the nature of the interventions, which cannot be blinded.

Intervention model description

Participants are randomly assigned to one of four parallel groups: massage, tub bath, sponge bath, or control.

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Inclusion criteria

Inclusion newborns (\>37 weeks gestation) * Receiving phototherapy * Stable vital signs * Parental consent

Exclusion criteria

* Congenital anomalies * Severe infections or sepsis * Parental refusal

Design outcomes

Primary

Measure	Time frame	Description
Change in Serum Bilirubin Levels	Baseline, 6 hours, 24 hours after intervention	Measured in mg/dL using standard laboratory testing

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026