The Effect of Newborn's First Bath Time on Physiological Variables

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time.

1. H₁: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on the peak heart rate.
2. H2: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on the peak heart rate.
3. H3: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on their respiratory rate.
4. H4: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on their respiratory rate.
5. H5: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on body temperature.
6. H6: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on body temperature.
7. H7: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on oxygen saturation.
8. H8: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on oxygen saturation.

Study Overview

• Status: Completed
• Conditions: Baths
• Intervention / Treatment: Other: Preterm group bathing 24 hours after birth.; Other: Preterm group bathing 48 hours after birth.; Other: Early term group bathing 24 hours after birth.; Other: Early term group bathing 48 hours after birth.

Detailed Description

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time. The research is a single-center, prospective parallel group randomized controlled experimental design study. The research was conducted with a total of 120 babies, 60 preterm babies and 60 early term babies, who received inpatient care and treatment in the neonatal intensive care unit between October 2022 and November 2023. Depending on randomization, newborns were bathed within 24 hours or 48 hours after birth. Physiological measurements of newborns were evaluated before application. Measurements were repeated after application, 10 minutes after application and 60 minutes after application. In the study, it was collected with the Baby Information Form and Physiological Variables Monitoring Form. Data were analyzed using chi-square, mean, percentage distributions, dependent groups t-test for comparison of intra-group measurements, repeated measures anova test, and independent groups t-test for comparison of quantitative continuous data. In the preterm group, the pre-bath respiration, body temperature and oxygen saturation values of newborns bathed within 48 hours were found to be significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05). In the early term group, it was found that the pre-bath heart rate peak values of newborns bathed within 48 hours were significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University Health Application and Research Center Farabi Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Newborns should be between 32 0/7 and 38 6/7 weeks.
• Birth weight must be over 2000 grams.
• He should not be connected to a mechanical ventilator.
• The parent must agree to work.

Exclusion Criteria:

• Less than 32 0/7 weeks.
• 39 0/7 weeks over.
• Being connected to a mechanical ventilator.
• Lacking epidermal integrity.
• Having an infection.
• Babies with anomalies and syndromes.
• Whose mother has an infection (hepatitis B, hepatitis C, HIV).
• Having phototherapy treatment.
• Having a body temperature below 36.5 °C.
• Having a body temperature above 37.5 ºC.
• Feeding within an hour before bathing.
• A painful procedure is performed within thirty minutes before bathing.
• Taking sedative medication.
• Those whose parents do not allow them to work.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Preterm (between 32 0/7 and 36 6/7 weeks)	Other: Preterm group bathing 24 hours after birth.; Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 2; Preterm (between 32 0/7 and 36 6/7 weeks)	Other: Preterm group bathing 48 hours after birth.; Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 3; Early term (between 37 0/7 and 38 6/7 weeks)	Other: Early term group bathing 24 hours after birth.; Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 4; Early term (between 37 0/7 and 38 6/7 weeks)	Other: Early term group bathing 48 hours after birth.; Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	Body temperature will be recorded and evaluated in degrees Celsius.	It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Respiratory rate	Respiration will be recorded and evaluated in numbers by counting for 1 minute by the researcher.	It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Heart rate	Heart rate will be recorded and evaluated in numbers by measuring with a monitor,	It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Oxygen saturation value	Oxygen saturation value will be recorded and evaluated in numbers by the monitor.	It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: infant, intensive care unit, baths, touch
• Other Study ID Numbers: KARADENIZTEKNIK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 12 months after publication
• IPD Sharing Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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