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

NCT06867523 | Completed

• 2 other identifiers: 2023-14/15THD-2025-1489
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

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

Keywords

Pediatric Intensive Care; Non-Pharmacological Interventions; Delirium Prevention; Pain Management; Critical Care Nursing

Outcome Measures

Primary Outcomes (2)

• Incidence of Delirium in Pediatric ICU Patients

  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.

  3 days after intervention

• Pain Levels in Pediatric ICU Patients

  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.

  3 days after intervention

Study Arms (2)

Eye Mask & Earplugs

EXPERIMENTAL

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.

Other: Eye Mask; Other: Earplugs

Standard Nursing Care

NO INTERVENTION

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.

Interventions

Eye Mask OTHER

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

Eye Mask & Earplugs

Earplugs OTHER

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.

Eye Mask & Earplugs

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bozok University

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (1)

• Hamza Ek, Aras Dogan S, Oto A. Short-term effects of eye masks and earplugs on delirium and pain in awake, spontaneously breathing pediatric intensive care patients: A randomized controlled trial. J Pediatr Nurs. 2026 Feb 23;88:117-126. doi: 10.1016/j.pedn.2026.02.015. Online ahead of print.

  PMID: 41734419 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study follows a double-blind design. Participants (patients) and care providers (nurses) are blinded to group assignments. However, outcome assessors (who are also nurses) may become aware of group allocations while assessing delirium and pain scores. The principal investigator is aware of the group assignments to ensure protocol adherence.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: August 25, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

TU (1)