Neonatal HyperbilirubinemiaNEO-BATHNCT07084987
Massage, Tub Bathing, and Sponge Bathing Effects on Neonatal Bilirubin and Comfort
A study testing neonatal massage, Tub Bathing and sponge bath in people with Neonatal Hyperbilirubinemia and Newborn Care Phototherapy, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia, Newborn Care Phototherapy
- What is being tested?
- neonatal massage, Tub Bathing and sponge bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Receiving phototherapy
- Stable vital signs
- Parental consent
Who cannot join
- Congenital anomalies
- Severe infections or sepsis
- Parental refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Education and Research Hospital
Bandırma, Balıkesir, 10200
About this study
Official title: 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
Read the 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.
- Being tested
- neonatal massage, Tub Bathing, sponge bath
- Keywords
- Neonatal Hyperbilirubinemia, Phototherapy, Neonatal Massage
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neonatal massageOther
Standardized neonatal massage before phototherapy
Tub BathingOther
Tub bath before phototherapy
sponge bathOther
Sponge (wipe) bath before phototherapy
| Study group | Role | What they receive |
|---|---|---|
| massage group | Experimental | Newborns receive standardized neonatal massages before phototherapy. Receives: Other: neonatal massage |
| Tub Bath Group | Experimental | Newborns receive a warm water tub bath prior to phototherapy. Receives: Other: Tub Bathing |
| Sponge Bath Group | Experimental | Newborns receive a sponge (wipe) bath before phototherapy. Receives: Other: sponge bath |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Bilirubin Levels
Measured in mg/dL using standard laboratory testing
Measured: Baseline, 6 hours, 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Sep 2021
- Primary completion1 Jan 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of four parallel groups: massage, tub bath, sponge bath, or control.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Öztürk, Uludag University
- Investigators
- Rukiye Öztürk, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084987
- Sponsor's protocol ID
- RUKİYEOZTURK-2025
- Other IDs
- 2021-42
- Acronym
- NEO-BATH
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage, Tub Bathing, and Sponge Bathing on Bilirubin Levels, Skin Barrier, Neonatal Comfort, and Vital Signs: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07084987
- Acronym / sponsor ID
- NEO-BATH / RUKİYEOZTURK-2025
- Keywords
- Neonatal Hyperbilirubinemia, Phototherapy, Neonatal Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to one of four parallel groups: massage, tub bath, sponge bath, or control.
| Arm | Type | Receives |
|---|---|---|
| massage group | Experimental | Other: neonatal massageNewborns receive standardized neonatal massages before phototherapy. |
| Tub Bath Group | Experimental | Other: Tub BathingNewborns receive a warm water tub bath prior to phototherapy. |
| Sponge Bath Group | Experimental | Other: sponge bathNewborns receive a sponge (wipe) bath before phototherapy. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Receiving phototherapy
- Stable vital signs
- Parental consent
Key exclusion criteria (3 listed)
- Congenital anomalies
- Severe infections or sepsis
- Parental refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neonatal massageStandardized neonatal massage before phototherapy | Other | massage group |
| Tub BathingTub bath before phototherapy | Other | Tub Bath Group |
| sponge bathSponge (wipe) bath before phototherapy | Other | Sponge Bath Group |
Primary outcome
Change in Serum Bilirubin Levels
Time frame: Baseline, 6 hours, 24 hours after intervention
Measured in mg/dL using standard laboratory testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and confidentiality.
Related trials for Neonatal Hyperbilirubinemia
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Foot Reflexology and Massage in Neonates Receiving Phototherapy
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rukiye Öztürk principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neonatal massage, Tub Bathing and sponge bath in people with Neonatal Hyperbilirubinemia and Newborn Care Phototherapy, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Bilirubin Levels (time frame: Baseline, 6 hours, 24 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.