Clinical trial NCT06819150: Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy
Official title: Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phototherapy Skin Rash
Keywords: Phototherapy
Newborn
Bilirubin
Bath
Comfort
Skin
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Information Form
timeFrame: First measurement-First day of hospitalization
measure: Follow-up form for physiologic parameters - Heart rate
timeFrame: Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
measure: Follow-up form for physiologic parameters -Respiratory rate
timeFrame: Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
measure: Follow-up form for physiologic parameters- Body temperature
timeFrame: Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
measure: Follow-up form for physiologic parameters- Oxygen saturation
timeFrame: Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
measure: Follow-up form for Skin moisture
timeFrame: Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
measure: Neonatal Skin Condition Score
timeFrame: 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.
measure: Bilirubin level
timeFrame: 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).
measure: The comfort level
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Şehir Hospital
state: Merkez
Study officials:
affiliation: Selcuk University
name: Perihan B Çalışkan, MSc student
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk University
name: Raziye Çelen, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: