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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811742
• Other study ID #: 010
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

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