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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bathing
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Birth focused on measuring Immersion bathing, showering, comfort, physiological parameters

Eligibility Criteria

37 Weeks - 40 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Okan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

immersion bathing group

showering group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Newborn Comfort Behavior Scale (NCBS)
The 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 rate
heart rate
oxygen saturation
body tempreture

Secondary Outcome Measures

Full Information

First Posted
March 12, 2021
Last Updated
March 19, 2021
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04811742
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Immersion bathing, showering, comfort, physiological parameters

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immersion bathing group
Arm Type
Experimental
Arm Description
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.
Arm Title
showering group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
bathing
Intervention Description
immerson bathing and showering
Primary Outcome Measure Information:
Title
Newborn Comfort Behavior Scale (NCBS)
Description
The 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.
Time Frame
2 minute
Title
Respiratory rate
Time Frame
1 minute
Title
heart rate
Time Frame
1 minute
Title
oxygen saturation
Time Frame
1 minute
Title
body tempreture
Time Frame
1 minute

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
newborn
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Okan University
City
İstanbul
ZIP/Postal Code
34959
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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