NCT07109908

Brief Summary

Objectıve: The aim of this study was to determine the effect of wipe (WG), shower (SG) and tub bath (TG) on stress level, skin moisture and physiological parameters used during the first bath in newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Hypotheses of the Research Hypothesis 01,2,3: There is no difference between wiping baths, wrapping baths and shower baths in terms of their effects on thermoregulation, stress level, skin moisture and physiological parameters of newborns. Hypothesis 11: Newborns who are given a wrap-up bath have a lower stress level than if they are swept and showered. Hypothesis 12: Newborns who are given a wrap-up bath have better skin moisture levels than newborns who are wiped and showered. Hypothesis 13: Physiological parameters (body temperature, heart peak, respiratory rate, oxygen saturation) of newborns who are given a wrap bath are less affected than wiping and showering.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

29 days

First QC Date

June 30, 2025

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Physiological Variables Follow-up Form

    Developed by researchers based on the literature (Taşdemir, 2017; Tibik and Şener, 2024) this form, physiological variables of the newborn; heart rate (min), respiratory rate (min), oxygen saturation value (%SpO2%), body temperature (°C) and neonatal skin condition score were used to record the evaluation results. The physiological parameters of the newborn were evaluated three times in each group: just before, immediately after bathing and 30 minutes after bathing.

    Just before bathing, just after bathing, and 30 minutes after bathing

  • Skin Moisture Tracking Form

    Developed by researchers based on the literature (Çeçen, 2023; Taşdemir and Efe, 2025). Skin moisture monitoring was measured with a skin moisture meter and recorded in the form. Skin moisture measurement was made by the same nurse from the determined areas (forehead, abdomen, forearm and upper leg) just before the bath and at the 6th, 12th hour and 24th hour after the bath. The Skin Moisture Meter is used to measure the amount of moisture at any point of the body only by contact with the skin, with its precise measurement feature. The humidity measurement of the device is in the range of 0% - 99.9%. The moisture meter weighs 40° and works effectively at ambient temperatures between 5° and 40° C (Konar et al., 2020).

    6th hour, 12th hour and 24th hour just before and after bath

  • Neonatal Stress Scale

    The neonatal stress scale was developed by Ceylan and Bolışık (2017) to assess the stress level in premature babies. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, consolation, muscle tone, extremities and posture and consists of a total of 24 items in 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. An increase in the score indicates that the baby's stress level has increased. Cronbach's Alpha values of the scale ranged from 0.65 to 0.81 for Observer 1 and 0.69 to 0.78 for Observer 2 (Ceylan and Bolışık 2017). The stress level of the newborns was evaluated 5 times through the Neonatal Stress Scale, 10 minutes before bathing, during the bath, immediately after the bath, 15 minutes after the bath, and 30 minutes after the bath.

    10 min before bathing, during bathing, just after bathing, 15 and 30 min after bathing

Study Arms (3)

Wiping Bath

EXPERIMENTAL

The babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes.

Behavioral: Wiping Bath

Wrapping Bath

EXPERIMENTAL

The first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes.

Behavioral: Wrapping Bath

Showering Bath

EXPERIMENTAL

The first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed.

Behavioral: Showering Bath

Interventions

Wiping BathBEHAVIORAL

The babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes.

Wiping Bath
Wrapping BathBEHAVIORAL

The first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes.

Wrapping Bath
Showering BathBEHAVIORAL

The first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed.

Showering Bath

Eligibility Criteria

Age1 Month - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight of 2500 g or more
  • Body temperature within the normal range (36-37.3°C)
  • Respiratory rate between 30-60 breaths per minute
  • Oxygen saturation above 85%
  • Absence of neurological problems (e.g., hypotonia, hypertonia)
  • Absence of congenital defects
  • No dermatological problems
  • Parental consent and voluntary participation in the research

You may not qualify if:

  • Presence of respiratory failure or distress
  • Requirement for ventilator support
  • Continuous need for high-concentration oxygen via methods such as hood or CPAP
  • History of convulsions
  • Clinical evidence of infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet Güney

Kastamonu, 37100, Turkey (Türkiye)

Location

Related Publications (7)

  • Burdall O, Willgress L, Goad N. Neonatal skin care: Developments in care to maintain neonatal barrier function and prevention of diaper dermatitis. Pediatr Dermatol. 2019 Jan;36(1):31-35. doi: 10.1111/pde.13714. Epub 2018 Dec 2.

    PMID: 30506880BACKGROUND
  • Cinar N, Yalnizoglu Caka S, Uslu Yuvaci H. Effect of newborn bathing training with the swaddled and tub bathing methods given to primiparous pregnant women on the mother's experience, satisfaction and newborn's stress during the first bathing of the newborn at home: A mixed method study. Jpn J Nurs Sci. 2020 Oct;17(4):e12363. doi: 10.1111/jjns.12363. Epub 2020 Aug 25.

    PMID: 32844590BACKGROUND
  • de Freitas P, Bueno M, Holditch-Davis D, Santos HP, Kimura AF. Biobehavioral Responses of Preterm Infants to Conventional and Swaddled Tub Baths: A Randomized Crossover Trial. J Perinat Neonatal Nurs. 2018 Oct/Dec;32(4):358-365. doi: 10.1097/JPN.0000000000000336.

    PMID: 29782435BACKGROUND
  • Edraki M, Paran M, Montaseri S, Razavi Nejad M, Montaseri Z. Comparing the effects of swaddled and conventional bathing methods on body temperature and crying duration in premature infants: a randomized clinical trial. J Caring Sci. 2014 Jun 1;3(2):83-91. doi: 10.5681/jcs.2014.009. eCollection 2014 Jun.

    PMID: 25276751BACKGROUND
  • Fernandez D, Antolin-Rodriguez R. Bathing a Premature Infant in the Intensive Care Unit: A Systematic Review. J Pediatr Nurs. 2018 Sep-Oct;42:e52-e57. doi: 10.1016/j.pedn.2018.05.002. Epub 2018 May 18.

    PMID: 29779763BACKGROUND
  • Higuchi S, Yoshida S, Minematsu T, Hatano Y, Notsu A, Ichinose T. Comparison of the Effects of Bathing and the Dry Technique on the Skin Condition of Early Neonates: A Prospective Observational Study. Ann Dermatol. 2023 Aug;35(4):256-265. doi: 10.5021/ad.22.098.

    PMID: 37550226BACKGROUND
  • Konar MC, Islam K, Roy A, Ghosh T. Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial. J Trop Pediatr. 2020 Apr 1;66(2):129-135. doi: 10.1093/tropej/fmz041.

    PMID: 31257430BACKGROUND

MeSH Terms

Conditions

Infant Behavior

Condition Hierarchy (Ancestors)

Child BehaviorBehavior

Study Officials

  • demet güney, MSc.

    https://sbf.kastamonu.edu.tr/index.php/boeluemler/ebelik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc., Research Assist

Study Record Dates

First Submitted

June 30, 2025

First Posted

August 7, 2025

Study Start

January 1, 2024

Primary Completion

January 30, 2024

Study Completion

November 30, 2024

Last Updated

August 7, 2025

Record last verified: 2025-07

Locations