Neonatal HyperbilirubinemiaNCT07771985
The Effects of Underrunning Water Bathing and Underrunning Water Bathing-Massage Combination on Bilirubin Levels in Term Newborns With Hyperbilirubinemia
A study testing Underrunning Water Bathing and Underrunning Water Bath + Massage Combination in people with Neonatal Hyperbilirubinemia, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to compare the effects of under running water bathing and underrunning water bathing combined with massage on bilirubin levels in term newborns receiving phototherapy. Read more about this study
- Who is it for?
- Ages 38 to 42 weeks
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Underrunning Water Bathing and Underrunning Water Bath + Massage Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2024to 6 Mar 2025
- 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 38 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term newborns with a gestational age between 38 and 42 weeks.
- Birth weight of 2500 g or higher.
- Newborns diagnosed with physiological hyperbilirubinemia.
- Newborns receiving phototherapy treatment.
- Postnatal age between 2 and 10 days.
- No congenital anomalies.
Show all 9Show fewer
- No additional health problems.
- Apgar score ≥7 at the 1st minute after birth.
- Stable vital signs.
Who cannot join
- Birth weight ≤2500 g.
- Gestational age less than 38 weeks.
- Pathological jaundice (e.g., ABO incompatibility, Rh incompatibility, biliary atresia, glucose-6-phosphate dehydrogenase deficiency, or glucuronyl transferase enzyme deficiency).
- Inability to feed orally.
- Postnatal age on the first day of life.
- Receiving blood transfusion therapy.
- Newborns with secondary conditions such as asphyxia or infection.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital, Neonatal Intensive Care Unit
Kayseri, Merkez
About this study
This randomized controlled study aimed to compare the effects of under running water bathing and underrunning water bathing combined with massage on bilirubin levels in term newborns receiving phototherapy. The study was conducted between June 2024 and March 2025 in the neonatal clinic of Kayseri City Hospital after obtaining institutional permission, ethics approval, and informed consent from the families. Ninety term newborns were randomly assigned to three groups:under running water bathing, under running water bathing +massage, and control (routine care). Bilirubin levels were measured before phototherapy and at the 12th and 24th hours. While bilirubin levels decreased over time in all groups, the underrunning water bathing combined massage group had significantly lower bilirubin levels than the control group at the 24th hour. The use of a underrunning water bath and massage combination is recommended as part of nursing care for term newborns receiving phototherapy.
Read the detailed description
Physiological hyperbilirubinemia is a common clinical condition in the neonatal period that requires clinical evaluation and medical monitoring. This prospective, randomized controlled experimental study aimed to compare the effects of underrunning water bathing and underrunning water bathing combined with massage on bilirubin levels in term newborns receiving phototherapy.
After obtaining institutional permission, ethics committee approval, and informed consent from the families, the study was conducted between June 2024 and March 2025 in the neonatal clinic of Kayseri City Hospital. The sample consisted of 90 term newborns who met the inclusion criteria. The newborns were randomly assigned to three groups: the Underrunning Water Bath Group (n=30), the Underrunning Water Bath+Massage Group (n=30), and the Control Group (n=30). No intervention other than routine clinical care was applied to the control group. The interventions in the experimental groups were performed by the researcher.
Data were collected using the Introductory Information Form and the Intervention Follow-up Form. Bilirubin levels were measured as total serum bilirubin before phototherapy and at the 12th and 24th hours. Data were analyzed using ANOVA, Bonferroni, Kruskal-Wallis, chi-square, and two-way repeated measures ANOVA tests.
A time-dependent decrease in bilirubin levels was observed in all groups. While no significant difference was found between the groups at the 12th hour (p>0.05), the bilirubin level in the underrunning water bathing combined with massage group was significantly lower than that of the control group at the 24th hour (p<0.05). The findings suggest that the combination of Underrunning water bathing and massage may be considered as a supportive nursing intervention for term newborns receiving phototherapy.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Underrunning Water Bathing, Underrunning Water Bath + Massage Combination
- Keywords
- Underrunning water bath, Massage, Newborn, Nurse, Phototherapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underrunning Water BathingOther
Following the baseline (T0) assessment, term newborns received an approximately 5-minute bath under running water as a supportive nursing intervention before the initiation of phototherapy. After the intervention, a second assessment of vital signs (T20) was performed, and phototherapy was subsequently initiated.Vital signs were reassessed at 12 and 24 hours after phototherapy initiation. Total serum bilirubin levels were measured at baseline (T0) and at 12 and 24 hours after phototherapy initiation.
Underrunning Water Bath + Massage CombinationOther
Term newborns received a 5-minute bath under running water followed by a 15-minute massage as a supportive nursing intervention after the baseline (T0) assessment and before the initiation of phototherapy. Following the intervention, a second vital sign assessment (T20) was performed, phototherapy was subsequently initiated.Vital signs were reassessed at 12 and 24 hours after phototherapy initiation. Total serum bilirubin levels were measured at baseline (T0) and at 12 and 24 hours after phototherapy initiation.
| Study group | Role | What they receive |
|---|---|---|
| Underrunning Water Bathing Group | Experimental | Term newborns receiving phototherapy will receive a underrunning water bathing before phototherapy as a nursing intervention. Receives: Other: Underrunning Water Bathing |
| Underrunning Water Bathing + Massage Group | Experimental | Term newborns receiving phototherapy will receive a underrunning water bathing followed by massage before phototherapy. Receives: Other: Underrunning Water Bath + Massage Combination |
| Control Group | No intervention | Term newborns receiving phototherapy will receive routine clinical care without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum Bilirubin Level Unit of Measure: mg/dL
Total serum bilirubin levels of term newborns receiving phototherapy will be measured to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group. Unit of Measure: mg/dL
Measured: Baseline (before initiation of phototherapy), 12 hours after initiation of phototherapy, and 24 hours after initiation of phototherapy
Secondary outcomes (4)
Heart Rate-Unit of Measure: Beats/min.
Heart rate was monitored and recorded at predetermined measurement time points in term newborns receiving phototherapy to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group.
Measured: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy), and T24 (24 hours after initiation of phototherapy).
Oxygen Saturation- Unıt of Measure %
Oxygen saturation was monitored and recorded at predetermined measurement time points in term newborns receiving phototherapy to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group.
Measured: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy), and T24 (24 hours after initiation of phototherapy).
Body Temperature-Unıt of Measure °C
Body temperature was monitored and recorded at predetermined measurement time points in term newborns receiving phototherapy to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group.
Measured: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy) , and T24 (24 hours after initiation of phototherapy).
Respiratory Rate- Unıt of Measure Breaths/min
Respiratory rate was measured and recorded at predetermined time points in term newborns receiving phototherapy to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group.
Measured: T0, T20, T12, and T24 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start17 Jun 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Şener Taplak, Bozok University
- Investigators
- Ayşe ŞENER TAPLAK, Associate Professor, PhD, Principal investigator, Yozgat Bozok Unıversty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771985
- Sponsor's protocol ID
- 2024-GOKAEK-245_05.06.2024_49
- Other IDs
- Yozgat Bozok University
- Status last verified
- Jan 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality concerns and institutional policies regarding data protection.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Underrunning Water Bathing and Underrunning Water Bathing-Massage Combination on Bilirubin Levels in Term Newborns With Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT07771985
- Acronym / sponsor ID
- 2024-GOKAEK-245_05.06.2024_49
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Underrunning water bath, Massage, Newborn, Nurse, Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 19 Aug 2026 (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 study aimed to compare the effects of under running water bathing and underrunning water bathing combined with massage on bilirubin levels in term newborns receiving phototherapy. The study was conducted between June 2024 and March 2025 in the neonatal clinic of Kayseri City Hospital after obtaining institutional permission, ethics approval, and informed consent from the families. Ninety term newborns were randomly assigned to three groups:under running water bathing, under running water bathing +massage, and control (routine care). Bilirubin levels were measured before phototherapy and at the 12th and 24th hours. While bilirubin levels decreased over time in all groups, the underrunning water bathing combined massage group had significantly lower bilirubin levels than the control group at the 24th hour. The use of a underrunning water bath and massage combination is recommended as part of nursing care for term newborns receiving phototherapy.
Detailed description
Physiological hyperbilirubinemia is a common clinical condition in the neonatal period that requires clinical evaluation and medical monitoring. This prospective, randomized controlled experimental study aimed to compare the effects of underrunning water bathing and underrunning water bathing combined with massage on bilirubin levels in term newborns receiving phototherapy.
After obtaining institutional permission, ethics committee approval, and informed consent from the families, the study was conducted between June 2024 and March 2025 in the neonatal clinic of Kayseri City Hospital. The sample consisted of 90 term newborns who met the inclusion criteria. The newborns were randomly assigned to three groups: the Underrunning Water Bath Group (n=30), the Underrunning Water Bath+Massage Group (n=30), and the Control Group (n=30). No intervention other than routine clinical care was applied to the control group. The interventions in the experimental groups were performed by the researcher.
Data were collected using the Introductory Information Form and the Intervention Follow-up Form. Bilirubin levels were measured as total serum bilirubin before phototherapy and at the 12th and 24th hours. Data were analyzed using ANOVA, Bonferroni, Kruskal-Wallis, chi-square, and two-way repeated measures ANOVA tests.
A time-dependent decrease in bilirubin levels was observed in all groups. While no significant difference was found between the groups at the 12th hour (p>0.05), the bilirubin level in the underrunning water bathing combined with massage group was significantly lower than that of the control group at the 24th hour (p<0.05). The findings suggest that the combination of Underrunning water bathing and massage may be considered as a supportive nursing intervention for term newborns receiving phototherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Underrunning Water Bathing Group | Experimental | Other: Underrunning Water BathingTerm newborns receiving phototherapy will receive a underrunning water bathing before phototherapy as a nursing intervention. |
| Underrunning Water Bathing + Massage Group | Experimental | Other: Underrunning Water Bath + Massage CombinationTerm newborns receiving phototherapy will receive a underrunning water bathing followed by massage before phototherapy. |
| Control Group | No intervention | –Term newborns receiving phototherapy will receive routine clinical care without additional intervention. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Term newborns with a gestational age between 38 and 42 weeks.
- Birth weight of 2500 g or higher.
- Newborns diagnosed with physiological hyperbilirubinemia.
- Newborns receiving phototherapy treatment.
- Postnatal age between 2 and 10 days.
Key exclusion criteria (7 listed)
- Birth weight ≤2500 g.
- Gestational age less than 38 weeks.
- Pathological jaundice (e.g., ABO incompatibility, Rh incompatibility, biliary atresia, glucose-6-phosphate dehydrogenase deficiency, or glucuronyl transferase enzyme deficiency).
- Inability to feed orally.
- Postnatal age on the first day of life.
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 |
|---|---|---|
| Underrunning Water BathingFollowing the baseline (T0) assessment, term newborns received an approximately 5-minute bath under running water as a supportive nursing intervention before the initiation of phototherapy. After the intervention, a second assessment of vital signs (T20) was performed, and phototherapy was subsequently initiated.Vital signs were reassessed at 12 and 24 hours after phototherapy initiation. Total serum bilirubin levels were measured at baseline (T0) and at 12 and 24 hours after phototherapy initiation. | Other | Underrunning Water Bathing Group |
| Underrunning Water Bath + Massage CombinationTerm newborns received a 5-minute bath under running water followed by a 15-minute massage as a supportive nursing intervention after the baseline (T0) assessment and before the initiation of phototherapy. Following the intervention, a second vital sign assessment (T20) was performed, phototherapy was subsequently initiated.Vital signs were reassessed at 12 and 24 hours after phototherapy initiation. Total serum bilirubin levels were measured at baseline (T0) and at 12 and 24 hours after phototherapy initiation. | Other | Underrunning Water Bathing + Massage Group |
Primary outcome
Total Serum Bilirubin Level Unit of Measure: mg/dL
Time frame: Baseline (before initiation of phototherapy), 12 hours after initiation of phototherapy, and 24 hours after initiation of phototherapy
Total serum bilirubin levels of term newborns receiving phototherapy will be measured to evaluate the effects of under-running water bathing and under-running water bathing combined with massage compared with a control group. Unit of Measure: mg/dL
4 secondary outcomes
Heart Rate-Unit of Measure: Beats/min.
Time frame: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy), and T24 (24 hours after initiation of phototherapy).
Oxygen Saturation- Unıt of Measure %
Time frame: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy), and T24 (24 hours after initiation of phototherapy).
Body Temperature-Unıt of Measure °C
Time frame: T0 (baseline before initiation of phototherapy), T20 (20 minutes after baseline), T12 (12 hours after initiation of phototherapy) , and T24 (24 hours after initiation of phototherapy).
Respiratory Rate- Unıt of Measure Breaths/min
Time frame: T0, T20, T12, and T24 .
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality concerns and institutional policies regarding data protection.
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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.
Ayşe ŞENER TAPLAK, Associate Professor, PhD principal investigator
Yozgat Bozok Unıversty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underrunning Water Bathing and Underrunning Water Bath + Massage Combination in people with Neonatal Hyperbilirubinemia, run by Bozok 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 9 inclusion and 7 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 19 Aug 2026. 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?
Total Serum Bilirubin Level Unit of Measure: mg/dL (time frame: Baseline (before initiation of phototherapy), 12 hours after initiation of phototherapy, and 24 hours after initiation of phototherapy). 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 19 Aug 2026.