Effect of a Bathing Care Package on Comfort and Skin Moisture in Preterm Infants in a Neonatal Intensive Care Unit

NCT07068737 | Completed

• 1 other identifier: NICU-BATH-2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This completed study evaluated the effects of a bathing care package on the comfort level and skin hydration of preterm infants admitted to the neonatal intensive care unit (NICU). Preterm infants, born before 37 weeks of gestation, often experience skin dryness and discomfort due to their immature skin barrier. The bathing care package involved a gentle bathing procedure using warm water at a specific temperature, performed in a basin with a wrapping technique. This procedure was carried out under controlled room temperature and humidity conditions to maximize infant comfort. Comfort-enhancing techniques were also applied during and after the bath. Preterm infants were randomly assigned to either the intervention group receiving the bathing care package or the control group receiving the standard bathing care routinely practiced in the NICU. Data collected throughout the study demonstrated that the bathing care package helped maintain skin hydration and preserve comfort levels better than the standard care. The findings contribute to improving neonatal nursing protocols aimed at enhancing the well-being of preterm infants. All procedures were conducted with informed consent from parents or legal guardians and approved by the institutional ethics committee.

Conditions

Preterm Birth; Skin Hydration in Preterm Infants; Comfort in Neonates; Bathing Care Package; Neonatal Nursing Care

Keywords

newborn; bath; bundle; nursing

Outcome Measures

Primary Outcomes (2)

• Neonatal comfort score

  The comfort level of preterm infants will be assessed using the Neonatal Comfort Behavior Scale (NCBS) at baseline and at 15 and 30 minutes after bathing to determine whether the bathing care package helps maintain comfort. Each item on the scale is scored from 1 to 5, and the evaluation is based on the total score. The total score on the Neonatal Comfort Behavior Scale (NCBS) can range from a minimum of 6 to a maximum of 30. A total score between 14 and 30 indicates that the infant is experiencing pain or distress, is not comfortable, and requires interventions to promote comfort.

  Before bath, and at 15 and 30 minutes after bath

• Skin moisture level

  Skin moisture levels of preterm infants will be measured using a non-invasive skin hydration monitor before the bath, and at 15 and 30 minutes after bathing to evaluate the effect of the bathing care package on skin moisture retention.

  Before bath, and at 15 and 30 minutes after bath

Study Arms (2)

Bathing care package group

EXPERIMENTAL

bathing care package group

Behavioral: bathing care package

routine bath group

ACTIVE COMPARATOR

routine bath group

Behavioral: routine bath

Interventions

bathing care package BEHAVIORAL

Participants receive a bathing care package that includes a swaddled immersion bath. Room temperature is maintained at 26-27°C with 40-60% humidity. Bath water temperature is controlled at 37-38°C. The infant is swaddled and immersed in water up to the shoulders while the head remains above water. The bath lasts no longer than 5 minutes. After bathing, the infant is gently dried without rubbing, wrapped in a towel, and placed in a pre-warmed incubator (31-34°C) for 10 minutes.

Bathing care package group

routine bath BEHAVIORAL

Participants receive routine bathing care according to NICU standards. This includes hand hygiene before the procedure, preparing necessary materials, placing the infant in a mesh sling in the bath, washing the body from clean to dirty areas with soft sponges and hospital-provided cleansing agents. The bath lasts up to 10 minutes. After bathing, the infant is quickly dried without rubbing and then diapered.

routine bath group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parental consent to participate in the study
• Gestational age between 32 and 37 weeks
• Admission to the Neonatal Intensive Care Unit
• Spontaneous breathing
• Stable physiological parameters
• Birth weight above 1500 g
• hours have passed since birth (WHO)

You may not qualify if:

• Birth weight below 1500 g
• Dependence on mechanical ventilation
• Diagnosed with sepsis
• Receiving sedatives and/or muscle relaxants
• Chromosomal abnormality
• Infant of a mother with hepatitis or HIV
• Meconium aspiration
• Chest tube, central venous catheter, drain, peritoneal dialysis catheter.

Sponsors & Collaborators

• Kiymet Aygün: lead

Study Sites (1)

Mersin City Education and Research Hospital

Mersin, Toroslar, 33240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kıymet Aygün, MSc

  Tarsus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator BSc, MSc Kıymet Aygün

Model Details: There is a bath care package group and a group that undergoes routine bathing at the clinic (control group). Randomisation was not performed.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: November 15, 2024
• Primary Completion: May 4, 2025
• Study Completion: May 23, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)