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

NCT04811742 | Completed

• 1 other identifier: 010
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth

Keywords

Immersion bathing; showering; comfort; physiological parameters

Outcome Measures

Primary Outcomes (5)

• 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.

  2 minute

• Respiratory rate

  1 minute

• heart rate

  1 minute

• oxygen saturation

  1 minute

• body tempreture

  1 minute

Study Arms (2)

immersion bathing group

EXPERIMENTAL

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.

Other: bathing

showering group

EXPERIMENTAL

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.

Other: bathing

Interventions

bathing OTHER

immerson bathing and showering

immersion bathing group; showering group

Eligibility Criteria

• Age: 37 Weeks - 40 Weeks
• Gender Eligibility Details: newborn
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Okan University

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Baths

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 23, 2021
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)