Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy

The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.

Study Overview

• Status: Recruiting
• Conditions: Phototherapy Skin Rash
• Intervention / Treatment: Other: Newborn bathing

Detailed Description

Neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. Jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. Currently, the appropriate treatment option for neonatal jaundice is phototherapy. Phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. However, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration.

Physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the pH value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. Invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. Therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity.

In the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. Phototherapy devices are widely used today for the treatment of jaundice. Phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. In the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. Also in the literature; There are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perihan B Çalışkan, MSc student; Phone Number: +90 5061626224 +90 5061626224; Email: perihanbeyza99@gmail.com
• Study Contact Backup: Name: Raziye Çelen, Asst. Prof.; Phone Number: +90 0332 241 01 10; Email: rturgut42@gmail.com

Study Locations

• Turkey
  • Merkez
    • Kütahya, Merkez, Turkey, 43050
      • Recruiting
      • Kütahya Şehir Hospital
      • Contact: Raziye Çelen, Asst. Prof.; Phone Number: +90 0332 241 01 10; Email: rturgut42@gmail.com
      • Contact: Perihan B Çalışkan, MSc student; Phone Number: +90 5061626224 +90 506 162 6224; Email: perihanbeyza99@gmail.com
      • Principal Investigator: Perihan B Çalışkan, MSc student
      • Sub-Investigator: Raziye Çelen, Asst. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Born at 35-41 gestational weeks
• Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more,
• No health problems,
• Indication for phototherapy treatment
• Stable vital signs
• Whose parents agreed to participate in the study

Exclusion Criteria:

• Newborns with ABO and Rh incompatibility,
• Direct diagnosis of hyperbilirubinaemia,
• Congenital anomaly,
• With skin lesions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newborn bathing; The term and preterm infants in the experimental group will have a bathtub bath before starting phototherapy treatment.	Other: Newborn bathing; The babies in the experimental group will have a bathtub bath before starting phototherapy treatment.
No Intervention: Standard of care; No intervention other than routine clinical practices will be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Information Form	The form, prepared by the researchers based on the literature, includes questions containing natal-postnatal information of preterm and term infants (date of birth, gestational week, postnatal age, gender, birth weight, mode of delivery, NICU admission date, initiation time of phototherapy, etc.).	First measurement-First day of hospitalization
Follow-up form for physiologic parameters - Heart rate	Heart rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.	Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters -Respiratory rate	Respiratory rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.	Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters- Body temperature	Body temperature will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.	Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters- Oxygen saturation	Oxygen saturation will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.	Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for Skin moisture	Skin moisture will be measured using a device (Digital Moisture Monitor for Skin) on the forehead, abdomen, back, arms (right-left) and legs (right-left).	Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Neonatal Skin Condition Score	Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.	Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
Bilirubin level	In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).	In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
The comfort level	The Newborn Comfort Behavior Scale (COMFORTneo) will assess the comfort of the newborn. The scale will evaluate the newborn's calmness/agitation, respiratory response, pain, body movements, facial tension, and muscle tone.The scale is scored between 6-30. As the score obtained from the scale increases, it shows that the newborn is uncomfortable and needs practices that will increase their comfort	The comfort level of the babies in the experimental and control groups will be evaluated 10 minutes before the treatment/bath. The comfort of the babies will be re-evaluated 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the bath or treatment.

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Perihan B Çalışkan, MSc student, Selcuk University; Principal Investigator: Raziye Çelen, Asst. Prof., Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Skin; Newborn; Phototherapy; Comfort; Bilirubin; Bath
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: 2023/78_TR

Drug and device information, study documents

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