Bozok University
Yozgat, 66100, Turkey (Türkiye)
NCT Number: NCT06867523
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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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Yozgat, 66100, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 3 days after intervention
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.
Time frame: 3 days after intervention
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.
Bozok University
Other
The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
Acronym: PICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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