Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
Launched by BOZOK UNIVERSITY · Mar 5, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether using eye masks and earplugs can help prevent confusion and pain in children aged 6 to 12 who are in the Pediatric Intensive Care Unit (PICU). The study will take place at Bursa City Hospital from August 2024 to June 2025 and will involve 74 children. Half of the participants will use eye masks and earplugs at night for three nights to see if this helps them sleep better and feel less pain, while the other half will receive regular care without these items.
To be eligible for this trial, children must be between 6 and 12 years old, expected to stay in the PICU for more than 24 hours, and not be receiving strong sedatives. Children with certain conditions, such as those with hearing aids, psychiatric diagnoses, or requiring mechanical ventilation, will not be included. Participants will be checked each morning to see how they are feeling and to assess their level of confusion and pain. The goal is to find out if reducing noise and light can improve the well-being of critically ill children in the hospital.
Gender
ALL
Eligibility criteria
- 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.
About Bozok University
Bozok University is a distinguished academic institution dedicated to advancing medical research and education. With a strong commitment to fostering innovative clinical trials, the university aims to enhance patient care and contribute to the scientific community. Leveraging a collaborative environment, Bozok University engages multidisciplinary teams of researchers, clinicians, and students to explore new therapeutic approaches and improve health outcomes. Through rigorous protocols and ethical standards, the university prioritizes the safety and well-being of trial participants while striving to generate impactful findings that can translate into real-world applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bursa, , Turkey
Yozgat, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported