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Completed

NCT Number: NCT07771985

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

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.

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Key information

Age range

38 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital, Neonatal Intensive Care Unit

Kayseri, Merkez, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Underrunning Water Bathing

Other

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 Combination

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

    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.

  2. 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).

    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.

  3. 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).

    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.

  4. Respiratory Rate- Unıt of Measure Breaths/min

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

    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.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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