ClinicalTrials.gg
CompletedNCT07771985Updated Aug 19, 2026

The Effects of Underrunning Water Bathing and Underrunning Water Bathing-Massage Combination on Bilirubin Levels in Term Newborns With Hyperbilirubinemia

An interventional study of Underrunning Water Bathing and Underrunning Water Bath + Massage Combination in Neonatal Hyperbilirubinemia, sponsored by Bozok University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 38 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Bozok University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
38 Weeks to 42 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Hyperbilirubinemia, Neonatal with a site in Turkey — 4 open to participants now, 4 under way, none of them phase 3. Hyperbilirubinemia, Neonatal · Turkey.

Enrollment
4th of 13
90 · median 68
Started
2024
with 4 others
No phase
13 of 17
3 open now
Registered
13th of 17
by date
Lead sponsor
1 of 17
Bozok University

Among the 17 studies in Hyperbilirubinemia, Neonatal with a site in Turkey, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is one of 5 that started in 2024, is one of 13 with no phase, and was the 13th registered.

Hyperbilirubinemia, Neonatal

96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

Browse Hyperbilirubinemia, Neonatal studies →

Open to participants now

4 of the 17 studies in Hyperbilirubinemia, Neonatal with a site in Turkey are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 14 Hyperbilirubinemia, Neonatal studies recruiting now, none (0%) set no upper age limit and 14 (100%) stop at 75 or younger; 13 take children under 18; 7 take healthy volunteers.

This study: 38 Weeks to 42 Weeks · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Hyperbilirubinemia, Neonatal with a site in Turkey, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Neonatal Hyperbilirubinemia

Keywords

  • Underrunning water bath
  • Massage
  • Newborn
  • Nurse
  • Phototherapy
04

Who can participate

Ages eligible
38 Weeks to 42 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • No additional health problems.
  • Apgar score ≥7 at the 1st minute after birth.
  • Stable vital signs.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Underrunning Water Bathing Group

    Term newborns receiving phototherapy will receive a underrunning water bathing before phototherapy as a nursing intervention.

    Other: Underrunning Water Bathing

  • Experimental
    Underrunning Water Bathing + Massage Group

    Term newborns receiving phototherapy will receive a underrunning water bathing followed by massage before phototherapy.

    Other: Underrunning Water Bath + Massage Combination

  • No intervention
    Control Group

    Term newborns receiving phototherapy will receive routine clinical care without additional intervention.

Interventions

  • OtherUnderrunning Water Bathing

    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.

  • OtherUnderrunning Water Bath + Massage Combination

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline (before initiation of phototherapy), 12 hours after initiation of phototherapy, and 24 hours after initiation of phototherapy

Secondary outcomes

  1. 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.

    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).

  2. 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.

    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).

  3. 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.

    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).

  4. 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.

    Time frame: T0, T20, T12, and T24 .

07

Study locations

1 site
  • Kayseri City Hospital, Neonatal Intensive Care Unit
    Kayseri, Merkez, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to confidentiality concerns and institutional policies regarding data protection.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Mar 2025, 8 months.

Of 34 non-industry interventional studies with no phase under Hyperbilirubinemia, Neonatal, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 8 months is below that.

Counting every sponsor, half of 34 studies reached it within 10 months; a quarter within 6 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Aug 19, 2026
StartActual
Jun 17, 2024
Primary completionActual
Mar 6, 2025
CompletionActual
Mar 6, 2025
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07771985
Lead sponsor
Bozok University
Responsible party
Ayşe Şener Taplak (Associate Professor, Bozok University) — Principal investigator
First posted
Aug 19, 2026
Start date
Jun 17, 2024
Primary completion
Mar 6, 2025
Completion
Mar 6, 2025
Last update
Aug 19, 2026

Study contacts

Ayşe ŞENER TAPLAK, Associate Professor, PhD
principal investigator · Yozgat Bozok Unıversty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion