NCT Number: NCT06819150
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.
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Request Info1 day–28 day
All sexes
Interventional
Not applicable
Kütahya, Merkez, 43050, Turkey (Türkiye)
Location status: Recruiting
Perihan B Çalışkan, MSc student
CONTACT
+90 506 162 6224 ext. +90 5061626224
Perihan B Çalışkan, MSc student
PRINCIPAL_INVESTIGATOR
Raziye Çelen, Asst. Prof.
CONTACT
Raziye Çelen, Asst. Prof.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The babies in the experimental group will have a bathtub bath before starting phototherapy treatment.
Time frame: First measurement-First day of hospitalization
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.).
Time frame: Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Heart rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Time frame: Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Respiratory rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Time frame: Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Body temperature will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Time frame: Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Oxygen saturation will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Time frame: Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
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
Contact information is provided by the study sponsor or research team.
Perihan B Çalışkan, MSc student
CONTACT
+90 5061626224 ext. +90 5061626224
Raziye Çelen, Asst. Prof.
CONTACT
Selcuk University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
