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

NCT ID: NCT04811742

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-09-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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immersion bathing group

Immersion bathing was started by placing the baby's whole body, except for the head and neck, into a bathtub of warm water with a depth of 13-14 cm. The baby was shampooed and cleaned in the tub. Then, the baby was taken out of the water and rinsed over the tub. Finally, the baby was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed.

Group Type EXPERIMENTAL

bathing

Intervention Type OTHER

immerson bathing and showering

showering group

Shower was started by keeping the baby's face down and firmly gripping the baby from his/her armpit and head by one of the nurse's hands. The baby was washed under running water with the other hand. The second nurse assisted to ensure the flow of water. After the baby was rinsed, he/she was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed.

Group Type EXPERIMENTAL

bathing

Intervention Type OTHER

immerson bathing and showering

Interventions

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bathing

immerson bathing and showering

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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Gülzade Uysal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Okan University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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010

Identifier Type: -

Identifier Source: org_study_id

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