Clinical trial NCT04811742: Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
Official title: Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Immersion bathing
showering
comfort
physiological parameters
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 69
Sex: ALL
Minimum age (years): 37
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A power analysis was performed to determine the sample size, which was calculated to include 31 newborns for each study group under the conditions of 0.05 significance level, 0.95 confidence interval and 0.95 power. Due to possible missing data, the sample size was increased by 10%, and the study was completed with a total of 69 newborns, including 35 in the immersion bathing group and 34 in the showering group.In this study, randomization by throwing a dice was used to allocate newborns into study groups. A dice was rolled for each newborn who met the study inclusion criteria, whereby the newborn was assigned to the immersion bathing group when an even number was observed, and to the showering group when an odd number was observed.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn

Detailed description: This study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units.

This is a randomized controlled experimental study. The sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. Study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). Environmental variables were kept the same for both groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort Behavior Scale (NCBS).

Eligibility criteria: Inclusion Criteria:

* Being a newborn born at the 37th gestational week and above,
* Completing 24 hours following the birth
* Having a stable condition (no tachycardia and bradycardia)

Exclusion Criteria:

* Having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as Hood and CPAP)
* Having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃)
* Having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial USG.

Primary outcomes:
measure: Newborn Comfort Behavior Scale (NCBS)
timeFrame: 2 minute
measure: Respiratory rate
timeFrame: 1 minute
measure: heart rate
timeFrame: 1 minute
measure: oxygen saturation
timeFrame: 1 minute
measure: body tempreture
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Okan University
Study officials:
References: