THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS

THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS: A RANDOMIZED CONTROLLED TRIAL

The neonatal mortality rate is a global issue and an important indicator reflecting the quality and accessibility of a country's healthcare system.

The main causes of death in newborns include premature birth, birth complications (birth asphyxia/trauma), and neonatal infections. Neonatal hypothermia is also associated with increased neonatal mortality. Therefore, the World Health Organization (WHO) has recommended a comprehensive neonatal care protocol to improve health outcomes for newborns. This protocol includes management steps such as emergency care at birth (delayed cord clamping, thorough drying, respiratory assessment, skin-to-skin contact, early initiation of breastfeeding), infection prevention, and thermal care (prevention of hypothermia).

Hypothermia is a condition in newborns where a drop in body temperature can lead to serious health problems such as metabolic acidosis, hypoglycemia, respiratory distress, hypoxia, bradycardia, hypotension, and infection. It is known that bathing newborns early on is therefore a significant risk factor for hypothermia in newborns.

Bathing newborns stimulates skin circulation, providing relaxation and a sense of well-being. It also contributes to the regulation of respiration and circulation, improvement of cell metabolism and capillary permeability, reduction of pain, increase in intestinal peristalsis, and decrease in bilirubin levels.

On the other hand, during bathing, light, noise, changes in ambient temperature, stress, and increased crying may cause thermal and cardiorespiratory changes in the newborn, such as heart rate, body temperature, respiratory rate, and oxygen saturation.

Delaying the first bath for at least 24 hours in newborns has been associated with reducing hypothermia and excessive crying, as well as benefiting from the vernix caseosa on the skin. Therefore, bathing under appropriate conditions and at the right time is critically important for newborn health.

Another important issue is the methods used for bathing newborns. There are various methods, such as tub bathing, sponge bathing, swaddling bathing, cradle bathing, bathing under running water, and oil bathing.

However, there was a need for more high-level evidence regarding the effect of different bathing methods used in term newborns on newborn health outcomes, and it was decided to conduct this study.

This study will provide important data for basing newborn care protocols on scientific evidence and improving clinical practices.

This randomized controlled study will compare immersion bathing (control group), swaddled bathing, and sponge bathing in term newborns to evaluate their effects on vital signs such as body temperature, heart rate, respiratory rate, and oxygen saturation.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Newborns
• Intervention / Treatment: Procedure: immersion bath of newborns; Procedure: swaddle bath of newborns; Procedure: sponge bath of newborns

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dilara Erdoğan, BSc; Phone Number: +905448054615; Email: erdogandilara03@gmail.com

Study Locations

• Turkey (Türkiye)
  • Sultangazi
    • Istanbul, Sultangazi, Turkey (Türkiye), 34265
      • Sultangazi Haseki Training and Research Hospital
      • Contact: Dilara Erdoğan, BSc; Phone Number: +905448054615; Email: erdogandilara03@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Hospitalized in the Level I Neonatal Intensive Care Unit of Sultangazi Haseki Training and Research Hospital
• Aged between 0-28 days
• 5-minute APGAR score ≥ 7
• Born at term (37-42 weeks of gestation)
• Birth weight ≥ 2500 grams
• No life-threatening condition
• No history of surgical procedures
• Stable vital signs within the last 24 hours
• Written informed consent obtained from the mother

Exclusion Criteria:

• Presence of congenital anomalies
• Presence of impaired skin integrity or open wounds
• Receiving mechanical ventilation or intubated
• Withdrawal of consent by the mother

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immersion bath of newborns; Newborns bathed using a immersion bath among the types of baths	Procedure: immersion bath of newborns; Newborns bathed using a immersion bath among the types of baths
Experimental: swaddle bath of newborns; Newborns bathed using a swaddle bath among the types of baths	Procedure: swaddle bath of newborns; Newborns bathed using a swaddle bath among the types of baths
Experimental: sponge bath of newborns; Newborns bathed using a sponge bath among the types of baths	Procedure: sponge bath of newborns; Newborns bathed using a sponge bath among the types of baths

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal body temperature	Forehead body temperature measured using non-contact infrared thermometer	Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	heart rate measured using standard neonatal monitoring equipment	Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
respiratory rate	respiratory rate measured through clinical observation	Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
oxygen saturation	peripheral oxygen saturation measured using pulse oximetry	Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Döndü Kurnaz, PhD, Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Midwifery; Term Newborn; Neonatal Care; Newborn Bathing; Neonatal Vital Signs
• Other Study ID Numbers: 546724004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No