Sleep in Pediatric Intensive Care Patients

Sleep Clinical Trial

Official title:

Investigation of the Effect of Sleep Band and White Noise Use on Time to Sleep in Pediatric Intensive Care Patients Aged 3-12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432076
• Other study ID #: Çukurova Üniversitesi
• Secondary ID: 15619243304
• Status: Completed
• Start date: June 21, 2022
• Est. completion date: January 11, 2023

Study information

• Verified date: January 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research will be carried out experimentally in order to investigate the Effect of Sleep Band and White Noise Use on the Time to Sleep in Pediatric Intensive Care Patients aged 3-12 months. The research will be carried out in Adana Province Seyhan State Hospital Pediatric Intensive Care Unit. The data obtained by creating experimental and control groups will be calculated. "Baby Information Form, Baby Sleep Problems Diagnosis Form, Baby Sleep Observation Form and Vital Findings Follow-up Chart" will be used to collect research data. In the study, sleep bands and white noise will be used for sleep for the babies in the experimental group, while the control group will not be interfered with. Ethics committee, institutional permission and informed consent from the parents of the infants will be obtained for the conduct of the study. SPSS demo package program will be used in data analysis. Examining the Effect Effect of Sleep Band and White Noise Use on Transition Time to Sleep in Pediatric Intensive Care Patients aged 3-12 months

, sleep ecology , sleep diagnostics Patients aged 3-12 months At the end of the research, it will be examined whether there is a difference between the sleep time, waking frequency and total sleep time of the babies in the experimental group using the sleep band and white noise, and the babies in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

Inclusion Criteria:

• Not taking intravenous sedation and anesthetic drugs for the last 12 hours

• Extubated

• Infant patients who do not have respiratory distress

• Absence of pain

Exclusion Criteria:

• Mechanically ventilated and intubated patients

• Patients hospitalized with the diagnosis of respiratory distress

• Patients with vision and hearing problems

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• Sleep Band and White Noise
Not taking any sedative or anesthetic drug in the last 12 hours (Such duration of action) An average of 12 hours of sleepiness at the patient's departure and travel hindrance will.) Being extubated A Glasgow coma scale of 15 (to be investigated by the Glasgow coma scale). Baby dreams of boredom Besides pain (to the "Wong Baker Face Scale" used in the Pediatric Intensive Care Unit) evaluation).

Locations

Country	Name	City	State
Turkey	Ebru Kaltar	Adana	Çukurova

Sponsors (1)

Lead Sponsor	Collaborator
Ebru Kilic

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep	This research will be carried out experimentally in order to investigate the Effect of Sleep Band and White Noise Use on the Time to Sleep in Pediatric Intensive Care Patients aged 3-12 months.	2 months