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

Bozok University

Status: Completed

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

Treatments: Other: Eye Mask; Other: Earplugs

Study type: Interventional

Funder types: Other

Identifiers

NCT06867523

2023-14/15

THD-2025-1489 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Eye Mask & Earplugs

Experimental group

Description:

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.

Treatment:

Other: Earplugs

Other: Eye Mask

Standard Nursing Care

No Intervention group

Description:

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.