CompletedNot Applicable

Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit

Turkey (Türkiye)74 participantsStarted 2024-08-25

Plain-language summary

This randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (PICU) patients aged 6-12 years. Research Questions This study seeks to answer the following key questions: Do eye masks and earplugs reduce the incidence of delirium compared to standard nursing care in PICU patients? Do eye masks and earplugs lower pain levels compared to standard nursing care in PICU patients? Study Design Participants will be randomly assigned to one of the following groups: Intervention Group: Participants will wear an eye mask and earplugs from 11:00 PM to 07:00 AM for three consecutive nights. Control Group: Participants will receive standard nursing care without any interventions. Both groups will be assessed daily at 08:00 AM using the following standardized measures: Cornell Pediatric Delirium Scale (to assess symptoms of confusion and disorientation) Validated faces-based pediatric pain scale via a secure telehealth platform (to measure pain levels) Glasgow Coma Scale (GCS) (to evaluate consciousness levels) Significance and Impact This study investigates the impact of reducing environmental stimuli (light and noise) on delirium incidence and pain levels in critically ill pediatric patients. The findings may contribute to the development of non-pharmacological interventions aimed at improving patient comfort and care in intensive care settings. Data Analysis Statistical analyses will be performed using SPSS (version 27) to compare delirium incidence and pain levels between the two groups.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Delirium in Pediatric ICU Patients

Timeframe: 3 days after intervention

Pain Levels in Pediatric ICU Patients

Timeframe: 3 days after intervention

Trial details

NCT IDNCT06867523

SponsorBozok University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

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