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Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn

Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04811742
Enrollment
69
Registered
2021-03-23
Start date
2018-09-01
Completion date
2019-09-01
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Immersion bathing, showering, comfort, physiological parameters

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).

Interventions

OTHERbathing

immerson bathing and showering

Sponsors

Okan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 40 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
heart rate1 minute
oxygen saturation1 minute
body tempreture1 minute
Newborn Comfort Behavior Scale (NCBS)2 minuteThe scale was developed by Dijk et al. (2009), and its Turkish validity and reliability study was performed by Kahraman et al. (2014). This is a five-point Likert type scale with six factors: alertness, calmness/agitation, respiratory response, physical movement, crying, muscle tone, and facial tension. The NCBS is used by nurses to assess the baby's comfort, pain and distress. Total score ranges from 6 to 30. A lower score indicates a higher newborn comfort level. A total score between 9-13 indicates that the baby is comfortable, whereas a total score between 14-30 indicates that the baby has pain and distress, that is, is uncomfortable and needs comfort enhancing interventions.
Respiratory rate1 minute

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026