Massage, Tub Bathing, and Sponge Bathing Effects on Neona... | NCT07084987

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

NCT07084987

Sponsor

Uludag University

Status

Completed

Last Update Posted

Jul 25, 2025Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Neonatal Hyperbilirubinemia
Newborn Care Phototherapy

Interventions

neonatal massage
Tub Bathing
sponge bath

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-42	Other Identifier	Bandırma 17 Eylül University Ethics Committee

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Jul 9, 2025

First Submission Date that Met QC Criteria

Jul 22, 2025

First Posted Date

Jul 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
neonatal massage	Other	Standardized neonatal massage before phototherapy	massage group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion newborns (>37 weeks gestation)

Receiving phototherapy
Stable vital signs
Parental consent

Exclusion Criteria:

Congenital anomalies
Severe infections or sepsis
Parental refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rukiye Öztürk	Uludag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bandırma Education and Research Hospital		Bandırma	Balıkesir	10200	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051556	Hyperbilirubinemia, Neonatal

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006932	Hyperbilirubinemia
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided