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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04811742
Other study ID # 010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2019

Study information

Verified date March 2021
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 37 Weeks to 40 Weeks
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
bathing
immerson bathing and showering

Locations

Country Name City State
Turkey Okan University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Respiratory rate 1 minute
Primary heart rate 1 minute
Primary oxygen saturation 1 minute
Primary body tempreture 1 minute
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