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

NCT ID: NCT07084987

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Neonatal Hyperbilirubinemia Newborn Care Phototherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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massage group

Newborns receive standardized neonatal massages before phototherapy.

Group Type EXPERIMENTAL

neonatal massage

Intervention Type OTHER

Standardized neonatal massage before phototherapy

Tub Bath Group

Newborns receive a warm water tub bath prior to phototherapy.

Group Type EXPERIMENTAL

Tub Bathing

Intervention Type OTHER

Tub bath before phototherapy

Sponge Bath Group

Newborns receive a sponge (wipe) bath before phototherapy.

Group Type EXPERIMENTAL

sponge bath

Intervention Type OTHER

Sponge (wipe) bath before phototherapy

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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neonatal massage

Standardized neonatal massage before phototherapy

Intervention Type OTHER

Tub Bathing

Tub bath before phototherapy

Intervention Type OTHER

sponge bath

Sponge (wipe) bath before phototherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion newborns (\>37 weeks gestation)

* Receiving phototherapy
* Stable vital signs
* Parental consent

Exclusion Criteria

* Congenital anomalies
* Severe infections or sepsis
* Parental refusal
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Rukiye Öztürk

REGİSTERED NURSE

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rukiye Öztürk

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Locations

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Bandırma Education and Research Hospital

Bandırma, Balıkesir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021-42

Identifier Type: OTHER

Identifier Source: secondary_id

RUKİYEOZTURK-2025

Identifier Type: -

Identifier Source: org_study_id

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