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Not yet recruiting NCT06808958

The Effect of Bathtub Bath on Stress and Comfort in Infants Receiving Phototherapy

No phase Interventional Bathtub Bath

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental (Bathtub Bath) Group.
Who it may be relevant to
Registry conditions: Bathtub Bath. Basic parameters: 1 Day — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

After intrauterine life, intensive care is a stressful environment for newborns who have to start their lives in the NICU. Many care practices in the NICU, including environmental factors (such as light, sound), heel prick blood collection, routine care, invasive interventions and bathing, are sources of stress for newborns. At the same time, the physical structure of the NICU, that is, factors such as sound, light, odor, and the physiological and anatomical immaturity of newborn babies, routine care and invasive procedures can reduce the comfort of the baby. Controlling the factors that may cause stress in the infant in the NICU and reducing stress and increasing comfort at the same time may affect the baby's healing process and discharge process. Recently, nursing care practices that reduce stress and increase comfort are at the forefront and have become an important concept today. In the literature, massage, kangaroo care, swaddling, listening to the mother's voice, listening to music, positioning, mother-scented hand simulation, breastfeeding, wrapping, bathing . Neonatal bathing is among the practices frequently performed by neonatal intensive care nurses to reduce the stress of the newborn and increase comfort Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction). Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction). Bowles (2013) found that neonatal bathing exfoliates dead skin cells, re-moisturizes the skin surface, reduces infant stress and agitation to provide comfort, encourages flexion and containment, and eventually provides developmentally supportive care. In the literature, there are many studies showing that bathing is also effective in reducing bilirubin levels in infants hospitalized with hyperbilirubinemia in neonatal intensive care units. Stimuli such as lighting, noise and pain from repeated medical interventions in the NICU can cause stress in infants. Excessive lighting can cause negative effects such as weight gain disorder, sleep disturbance and stress in infants. Since phototherapy light is not only a source of stress for the baby receiving phototherapy but also one of the important factors affecting the comfort level, the comfort of babies receiving phototherapy should be monitored frequently. The physical conditions of NICUs, physiologic and anatomic conditions of the infants receiving treatment, invasive interventions and care lead to a decrease in the comfort level of newborns. This situation negatively affects the discharge time and recovery of newborns. Therefore, this study will be conducted to examine the effect of bathtub bathing on stress level and comfort in infants receiving phototherapy in neonatal intensive care.

Interventions

  • Behavioral Experimental (Bathtub Bath) Group
    The newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. The position (face down and back down) is changed every two hours. And phototherapy is paused every three hours for feeding. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath

Primary outcome measures

  • Newborn Stress Scale [Time frame: Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, 0 minutes before, 15 minutes after starting and 15 min]
Secondary outcome measures (1)
  • Newborn Comfort Behavior Scale [Time frame: 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the photo]

Eligibility criteria

Inclusion criteria

  • Newborns with a gestational age of 37 weeks and above
  • Birth weight of 2500 grams and above
  • Having completed 24 hours after birth
  • The newborn is hospitalized with a diagnosis of physiological hyperbilirubinemia and is receiving phototherapy
  • No accompanying disease
  • No accompanying treatment
  • Stable physiological parameters (no tachycardia and bradycardia)
  • No respiratory failure or distress (respiratory rate between 30-60, not being monitored on a ventilator, oxygen saturation of 90% and above, no need for continuous high concentration oxygen with methods such as Hood, CPAP, etc.)
  • The baby is hospitalized during data collection
  • The parents are willing for the newborn to participate in the study Exclusion Criteria
  • Preterms with a gestational age of 22-37 weeks,
  • The newborn has another concomitant disease diagnosis
  • Has been wiped or bathed in a tub within the last 12 hours
  • Has been hospitalized with a diagnosis of pathological hyperbilirubinemia
  • Has been given sedatives and/or muscle relaxants
  • The parent does not want the newborn to participate in the study or wants/wants to withdraw from the study while the study is ongoing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06808958 · 124567

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗