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Completed

NCT Number: NCT05432076

Sleep in Pediatric Intensive Care Patients

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.

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Key information

Conditions

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ebru Kaltar

Adana, Çukurova, 01170, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Sleep Band, White Noise

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ebru Kilic

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2022
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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