Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 5:49 PM
Study NCT ID:
NCT06867523
Status:
None
Last Update Posted:
2025-08-21 00:00:00
First Post:
2025-03-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
Sponsor:
None
Organization:
Study Overview
Official Title:
The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICU
Brief Summary:
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) 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: