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| ID | Type | Description | Link |
|---|---|---|---|
| THD-2025-1489 | Other Grant/Funding Number | Bozok University Scientific Research Projects Unit (BAP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye Mask & Earplugs | Experimental | Participants in this group will use an eye mask and earplugs between 11:00 PM and 07:00 AM for three consecutive nights. The goal is to reduce environmental stimuli and evaluate the effects on delirium incidence and pain levels. |
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| Standard Nursing Care | No Intervention | Participants in this group will receive standard nursing care without the use of an eye mask or earplugs. Their delirium incidence and pain levels will be assessed under usual care conditions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Mask | Other | Participants in this group will wear an eye mask between 11:00 PM and 07:00 AM for three consecutive nights to assess its effects on delirium and pain levels in pediatric intensive care unit patients |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Delirium in Pediatric ICU Patients | Delirium incidence will be assessed using the Cornell Pediatric Delirium Scale every morning at 08:00 AM for three consecutive days. The nurse rates each item of the screening questions on a scale from 0 (lowest) to 4 (highest). Scores ≥9 indicate delirium. | 3 days after intervention |
| Pain Levels in Pediatric ICU Patients | Pain levels will be assessed every morning at 08:00 AM for three consecutive days using a validated faces-based pediatric pain assessment tool administered via a secure telehealth platform. | 3 days after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bozok University | Yozgat | Yozgat | 66100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41734419 | Derived | Hamza Ek, Aras Dogan S, Oto A. Short-term effects of eye masks and earplugs on delirium and pain in awake, spontaneously breathing pediatric intensive care patients: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:117-126. doi: 10.1016/j.pedn.2026.02.015. Epub 2026 Feb 23. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).
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This study follows a double-blind design. Participants (patients) and care providers (nurses) are blinded to group assignments. However, outcome assessors (who are also nurses) may become aware of group allocations while assessing delirium and pain scores. The principal investigator is aware of the group assignments to ensure protocol adherence.
| Earplugs | Other | Participants in this group will use earplugs between 11:00 PM and 07:00 AM for three consecutive nights to evaluate their effects on delirium incidence and pain levels. |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |