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

NCT ID: NCT06808958

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Bathtub Bath

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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. 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 application will be started. The bath application will be completed in a time not exceeding 5 minutes. 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, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort stress and comfort scores will be recorded on the Newborn Follow-up Form.

Group Type: EXPERIMENTAL

Experimental (Bathtub Bath) Group

Intervention Type: BEHAVIORAL

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 application will be started. The bath application will be completed in a time not exceeding 5 minutes. 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, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor

Control Group

nformation about the newborns selected for the control group (gender of the baby, gestational week, delivery method, etc.) will be taken from the newborn file and recorded on the form containing the newborn's introductory information. Physiological parameter, stress and comfort assessments will be performed on the newborns in the control group without any different application, immediately before the phototherapy session starts, 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scores will be recorded on the Newborn Follow-up Form.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 application will be started. The bath application will be completed in a time not exceeding 5 minutes. 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, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor

Intervention Type: BEHAVIORAL

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

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erzincan Binali Yildirim Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Necla Kasımoğlu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

NECLA KASIMOĞLU, Dr

Role: CONTACT

necla_24celik@hotmail.com

05072275742

Other Identifiers

124567

Identifier Type: -

Identifier Source: org_study_id