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

NCT07771985 | Completed

• 2 other identifiers: 2024-GOKAEK-245_05.06.2024_49Yozgat Bozok University
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

Underrunning water bath; Massage; Newborn; Nurse; Phototherapy

Outcome Measures

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

  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.

  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 %

  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

  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

  T0, T20, T12, and T24 .

Study Arms (3)

Underrunning Water Bathing Group

EXPERIMENTAL

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

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.

Other: Underrunning Water Bath + Massage Combination

Control Group

NO INTERVENTION

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

Interventions

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 Bathing Group

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.

Underrunning Water Bathing + Massage Group

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Kayseri City Hospital, Neonatal Intensive Care Unit

Kayseri, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe ŞENER TAPLAK, Associate Professor, PhD

  Yozgat Bozok Unıversty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: August 19, 2026
• Study Start: June 17, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: August 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)