THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS

NCT07445139 | Not Yet Recruiting

• 1 other identifier: 546724004
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Newborns

Keywords

Term Newborn; Midwifery; Newborn Bathing; Neonatal Vital Signs; Neonatal Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heart rate

  Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

• respiratory rate

  Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

• oxygen saturation

  Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

Study Arms (3)

immersion bath of newborns

EXPERIMENTAL

Newborns bathed using a immersion bath among the types of baths

Procedure: immersion bath of newborns

swaddle bath of newborns

EXPERIMENTAL

Newborns bathed using a swaddle bath among the types of baths

Procedure: swaddle bath of newborns

sponge bath of newborns

EXPERIMENTAL

Newborns bathed using a sponge bath among the types of baths

Procedure: sponge bath of newborns

Interventions

sponge bath of newborns PROCEDURE

Newborns bathed using a sponge bath among the types of baths

sponge bath of newborns

immersion bath of newborns PROCEDURE

Newborns bathed using a immersion bath among the types of baths

immersion bath of newborns

swaddle bath of newborns PROCEDURE

Newborns bathed using a swaddle bath among the types of baths

swaddle bath of newborns

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalized in the Level I Neonatal Intensive Care Unit of Sultangazi Haseki Training and Research Hospital
• Aged between 0-28 days
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Study Officials

• Döndü Kurnaz, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara Erdoğan, BSc

CONTACT

+905448054615; erdogandilara03@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: msc midwifery student

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

TU (1)