Massage, Tub Bathing, and Sponge Bathing Effects on Neonatal Bilirubin and Comfort (NEO-BATH)

July 22, 2025 updated by: Rukiye Öztürk, Uludag University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balikesi̇r
      • Bandırma, Balikesi̇r, Turkey, 10200
        • Bandırma Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion newborns (>37 weeks gestation)

  • Receiving phototherapy
  • Stable vital signs
  • Parental consent

Exclusion Criteria:

  • Congenital anomalies
  • Severe infections or sepsis
  • Parental refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: massage group
Newborns receive standardized neonatal massages before phototherapy.
Other: neonatal massage
Standardized neonatal massage before phototherapy
Experimental: Tub Bath Group
Newborns receive a warm water tub bath prior to phototherapy.
Other: Tub Bathing
Tub bath before phototherapy
Experimental: Sponge Bath Group
Newborns receive a sponge (wipe) bath before phototherapy.
Other: sponge bath
Sponge (wipe) bath before phototherapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Principal Investigator: Rukiye Öztürk, Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUKİYEOZTURK-2025
  • 2021-42 (Other Identifier: Bandırma 17 Eylül University Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to protect participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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