Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit

Not Applicable

Recruiting

• Conditions: Pain Management; Pediatric Intensive Care Unit; Non-Pharmacological Interventions; Pediatric Delirium; Critical Care Nursing

• Registration Number: NCT06867523
• Lead Sponsor: Bozok University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-25
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-05-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium in Pediatric ICU Patients	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.
Pain Levels in Pediatric ICU Patients	3 days after intervention	Pain levels will be measured using the Wong-Baker Faces Pain Scale every morning at 08:00 AM for three consecutive days. Minimum Score: 0 (No Pain); Maximum Score: 10 (Severe Pain). High Score: Indicates higher levels of pain.

Trial Locations

Locations (1)

Bozok University; 🇹🇷 Yozgat, Turkey