Sleep in Pediatric Intensive Care Patients

January 11, 2023 updated by: Ebru Kilic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çukurova
      • Adana, Çukurova, Turkey, 01170
        • Ebru Kaltar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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).
Other Names:
  • White Noise
  • Sleep Band
control group
while the control group will not be interfered with

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep
Time Frame: 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ebru Kilic

Investigators

  • Study Director: Şenay Çetinkaya, Çukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Actual)

January 11, 2023

Study Completion (Actual)

January 11, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Çukurova Üniversitesi
  • 15619243304 (Other Identifier: çukurova üniversitesi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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