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Simple sleep aids may cut delirium and pain in hospitalized kids

NCT ID NCT06867523

Symptom relief Sponsor: Bozok University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether wearing eye masks and earplugs at night for three nights could help prevent confusion (delirium) and reduce pain in children aged 6-12 in the pediatric intensive care unit (PICU). 74 children were randomly assigned to either wear the sleep aids or receive standard care. The goal was to see if blocking light and noise could improve comfort and mental clarity without medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

74 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Being between the ages of 6 and 12 years. * Receiving treatment in the Pediatric Intensive Care Unit (PICU). * Expected to stay in the intensive care unit for more than 24 hours. * Having a Glasgow Coma Scale (GCS) score of 9 or above. * Not receiving sedation. Exclusion Criteria: * Children with diagnosed intellectual, auditory, or visual impairments. * Children with a psychiatric diagnosis. * Patients using hearing aids. * Patients diagnosed with brain tumors. * Patients requiring mechanical ventilation. * Patients using benzodiazepines or other strong sedative medications. * Patients with an expected ICU stay of fewer than three days.

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Conditions

The condition(s) this trial relates to.

agnosia delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical care nursing Non-pharmacological interventions Pain management Pediatric delirium Pediatric intensive care unit

Contacts and locations

Locations

  • Bozok University

    Yozgat, Yozgat, 66100, Turkey (Türkiye)

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