SleepNCT05432076
Sleep in Pediatric Intensive Care Patients
An observational study of Sleep, run by Ebru Kilic at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Band and White Noise
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2022to 11 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- Not taking intravenous sedation and anesthetic drugs for the last 12 hours
- Extubated
- Infant patients who do not have respiratory distress
- Absence of pain
Who cannot join
- Mechanically ventilated and intubated patients
- Patients hospitalized with the diagnosis of respiratory distress
- Patients with vision and hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Sleep Band and White Noise
- Keywords
- White noise, sleep band, pediatric intensive care, baby/child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Band and White NoiseDevice
Also called Sleep Band, 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).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | In the study, sleep bands and white noise will be used for sleep for the babies in the experimental group Receives: Device: Sleep Band and White Noise | |
| control group | while the control group will not be interfered with |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start21 Jun 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru Kilic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Kilic, Cukurova University
- Investigators
- Şenay Çetinkaya, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432076
- Sponsor's protocol ID
- Çukurova Üniversitesi
- Other IDs
- 15619243304
- Status last verified
- Jan 2023
- First submitted
- 21 Jun 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05432076
- Acronym / sponsor ID
- Çukurova Üniversitesi
- Conditions
- Sleep
- Keywords
- White noise, sleep band, pediatric intensive care, baby/child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ebru KilicUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Device: Sleep Band and White NoiseIn the study, sleep bands and white noise will be used for sleep for the babies in the experimental group |
| control group | – | –while the control group will not be interfered with |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- Not taking intravenous sedation and anesthetic drugs for the last 12 hours
- Extubated
- Infant patients who do not have respiratory distress
- Absence of pain
Key exclusion criteria (3 listed)
- Mechanically ventilated and intubated patients
- Patients hospitalized with the diagnosis of respiratory distress
- Patients with vision and hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Band and White NoiseAlso: Sleep Band, White NoiseNot 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). | Device | experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şenay Çetinkaya study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Ebru Kilic at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.