Sleep in Pediatric Intensive Care Patients

NCT05432076 | Completed

• 2 other identifiers: Çukurova Üniversitesi15619243304
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

White noise; sleep band; pediatric intensive care; baby/child

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

experimental group

In the study, sleep bands and white noise will be used for sleep for the babies in the experimental group

Device: Sleep Band and White Noise

control group

while the control group will not be interfered with

Interventions

Sleep Band and White Noise DEVICE

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).

Also known as: Sleep Band, White Noise

experimental group

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The sample of the study consists of a total of 78 patients, 39 in the experimental and 39 in the control group. As a result of the power analysis using the G\*Power 3.0.10 program; A total of at least 78 samples were found to be sufficient with 90% power and 5% margin of error (n1: 39, n2: 39).

You may qualify if:

• Not taking intravenous sedation and anesthetic drugs for the last 12 hours
• Extubated
• Infant patients who do not have respiratory distress
• Absence of pain

You may not qualify if:

• Mechanically ventilated and intubated patients
• Patients hospitalized with the diagnosis of respiratory distress
• Patients with vision and hearing problems

Sponsors & Collaborators

• Ebru Kilic: lead

Study Sites (1)

Ebru Kaltar

Adana, Çukurova, 01170, Turkey (Türkiye)

Location

Study Officials

• Şenay Çetinkaya

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 21, 2022
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

TU (1)