Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
NCT ID: NCT06867523
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2024-08-25
2025-06-30
Brief Summary
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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) Wong-Baker Faces Pain Scale (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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Eye Mask & Earplugs
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.
Eye Mask
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
Earplugs
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.
Standard Nursing Care
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.
No interventions assigned to this group
Interventions
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Eye Mask
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
Earplugs
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
12 Years
ALL
No
Sponsors
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Bozok University
OTHER
Responsible Party
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Şenay ARAS DOĞAN
Asst. Prof. Dr.
Locations
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Bozok University
Yozgat, Yozgat, Turkey (Türkiye)
Countries
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Other Identifiers
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THD-2025-1489
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2023-14/15
Identifier Type: -
Identifier Source: org_study_id
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