The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies

NCT06166485 | Completed DMC

• 1 other identifier: IstanbulUCEdu
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the bath applied to term babies in two different orders (first washing the body and lastly the head, and the classical method in which the whole body is washed starting from the head first), the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (time of bathing). ) was planned to determine its effect on the calming time of babies. The effects of two different bathing methods given to healthy and term babies on the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (bathing time), and calming time of the babies will be compared.

Conditions

Newborn

Keywords

baby health; stress; newborn bath; newborn

Outcome Measures

Primary Outcomes (2)

• Newborn stress scale

  This scale can evaluate the stress level in newborns.Scale items are grouped into 8 subgroups.These subgroups consist of a total of 24 items in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture.In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.

  This scale evaluation will be applied to healthy, term babies who are hospitalized in the neonatal clinic within a 3-month period and the study will be conducted.

• Data collection form

  The form consists of 4 sections and 36 questions in total. The first part of the form is a 7-question form to collect demographic and obstetric information of mothers who agreed to participate in the study. The second part is a 9-question form in which information about the baby to be included in the study is collected. In the third section, it is a form with 15 questions in which information about the application is collected. In the fourth section, it is a form with 5 questions in which information regarding the evaluation of the baby with the stress scale is collected.

  The 36-question data collection form will be applied to the mother of the baby on whom the study will be conducted and to the observers making the evaluation within 3 months of data collection.

Study Arms (2)

1st group babies where the head is washed first and then the whole body

ACTIVE COMPARATOR

The effects of washing the head first and then the whole body on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the first group babies will be examined.

Other: take a bath

2nd group babies, where the whole body is washed first and the head is washed last.

ACTIVE COMPARATOR

The effects on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the second group of babies, where the whole body is washed first and the head last, will be examined.

Other: take a bath

Interventions

take a bath OTHER

The effects of two different bathtub bath methods on physiological parameters will be compared in babies divided into 2 different groups.

1st group babies where the head is washed first and then the whole body; 2nd group babies, where the whole body is washed first and the head is washed last.

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The baby's body weight is between 2.5 - 4 kg
• The baby's Apgar score is \>7
• The baby does not have any health problems
• Their parents agree to participate in the study
• Having a healthy term baby.

You may not qualify if:

• Meconium aspiration etc. washed immediately after birth for various reasons,
• Having various health problems,
• Their parents did not agree to participate in the study,
• Low birth weight and premature babies

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, 34, Turkey (Türkiye)

Location

Related Publications (7)

• Huang Y, Zhou L, Abdillah H, Hu B, Jiang Y. Effects of swaddled and traditional tub bathing on stress and physiological parameters of preterm infants: A randomized clinical trial in China. J Pediatr Nurs. 2022 May-Jun;64:e154-e158. doi: 10.1016/j.pedn.2021.11.028. Epub 2021 Dec 23.

  PMID: 34953663 BACKGROUND

• Kusari A, Han AM, Virgen CA, Matiz C, Rasmussen M, Friedlander SF, Eichenfield DZ. Evidence-based skin care in preterm infants. Pediatr Dermatol. 2019 Jan;36(1):16-23. doi: 10.1111/pde.13725. Epub 2018 Dec 12.

  PMID: 30548578 BACKGROUND

• 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: 29779763 BACKGROUND

• Moser WJ, Bilka KR, Vrouwe SQ, Glick JC, Ramaiah V. Running water while bathing is a risk factor for pediatric scald burns. Burns. 2023 Nov;49(7):1714-1718. doi: 10.1016/j.burns.2023.03.014. Epub 2023 Mar 23.

  PMID: 37193613 BACKGROUND

• Ar I, Gozen D. Effects of Underrunning Water Bathing and Immersion Tub Bathing on Vital Signs of Newborn Infants: A Comparative Analysis. Adv Neonatal Care. 2018 Dec;18(6):E3-E12. doi: 10.1097/ANC.0000000000000484.

  PMID: 30507829 BACKGROUND

• Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.

  PMID: 31442786 BACKGROUND

• Kocak AD, Inal S. The effect of bath applied in two different sequences on stress level and physiological parameters in term babies. J Pediatr Nurs. 2026 Jan 7;87:50-57. doi: 10.1016/j.pedn.2025.12.025. Online ahead of print.

  PMID: 41505829 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife

Model Details: This study was planned as a randomized controlled experimental study. Computer-assisted randomization will be used to create groups (https://www.randomizer.org/). Power analysis was performed using the G\*Power (v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: December 12, 2023
• Study Start: July 18, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 21, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)