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

NCT07084987 | Completed DMC

• 2 other identifiers: RUKİYEOZTURK-20252021-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Hyperbilirubinemia; Newborn Care Phototherapy

Keywords

Neonatal Hyperbilirubinemia; Phototherapy; Neonatal Massage

Outcome Measures

Primary Outcomes (1)

• Change in Serum Bilirubin Levels

  Measured in mg/dL using standard laboratory testing

  Baseline, 6 hours, 24 hours after intervention

Study Arms (4)

massage group

EXPERIMENTAL

Newborns receive standardized neonatal massages before phototherapy.

Other: neonatal massage

Tub Bath Group

EXPERIMENTAL

Newborns receive a warm water tub bath prior to phototherapy.

Other: Tub Bathing

Sponge Bath Group

EXPERIMENTAL

Newborns receive a sponge (wipe) bath before phototherapy.

Other: sponge bath

Control Group

NO INTERVENTION

Interventions

neonatal massage OTHER

Standardized neonatal massage before phototherapy

massage group

Tub Bathing OTHER

Tub bath before phototherapy

Tub Bath Group

sponge bath OTHER

Sponge (wipe) bath before phototherapy

Sponge Bath Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Receiving phototherapy
• Stable vital signs
• Parental consent

You may not qualify if:

• Congenital anomalies
• Severe infections or sepsis
• Parental refusal

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bandırma Education and Research Hospital

Bandırma, Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Rukiye Öztürk

  Uludag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open-label due to the nature of the interventions, which cannot be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: REGİSTERED NURSE

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

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 25, 2025
• Study Start: September 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)