Using eye masks and earplugs to prevent delirium and pain in children in the ICU
The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
This study is testing if using eye masks and earplugs can help reduce pain and confusion in children aged 6-12 who are staying in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Bozok University Academic / other |
| Locations | 1 site (Yozgat) |
| Trial ID | NCT06867523 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of eye masks and earplugs in reducing delirium and pain levels in pediatric patients aged 6-12 years in the Pediatric Intensive Care Unit (PICU). Participants will be randomly assigned to either an intervention group, where they will use eye masks and earplugs overnight, or a control group receiving standard nursing care. The study aims to determine if these non-pharmacological interventions can lead to better outcomes compared to traditional care. Daily assessments will be conducted to measure delirium symptoms and pain levels using standardized scales.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 years who are being treated in the PICU and are expected to stay for more than 24 hours.
Not a fit: Patients with intellectual, auditory, or visual impairments, or those requiring mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort and mental well-being of children in the PICU.
How similar studies have performed: While similar non-pharmacological interventions have shown promise in other settings, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Yozgat
- Bozok University — Yozgat, Turkey (Recruiting)
Study contacts
- Study coordinator: ŞENAY ARAS DOĞAN, PhD
- Email: senay.arasdogan@yobu.edu.tr
- Phone: +905068842307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.