NCT06867523: PICU

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

Completed NA Last updated 3 February 2026

What this trial tests

NA trial testing Eye Mask in Pain Management in 74 participants. Completed in 30 June 2025.

Timeline

25 August 2024

Primary endpoint
30 May 2025

30 June 2025

Quick facts

Lead sponsor	Bozok University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	74
Start date	25 August 2024
Primary completion	30 May 2025
Estimated completion	30 June 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Eye Mask
• Earplugs

Conditions studied

• Pain Management — all drugs for Pain Management →
• Pediatric Intensive Care Unit — all drugs for Pediatric Intensive Care Unit →
• Non-Pharmacological Interventions — all drugs for Non-Pharmacological Interventions →
• Critical Care Nursing — all drugs for Critical Care Nursing →

Sponsor

Bozok University

Who can join

Adults 6 to 12, any sex, with Pain Management or Pediatric Intensive Care Unit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Short-term effects of eye masks and earplugs on delirium and pain in awake, spontaneously breathing pediatric intensive care patients: A randomized controlled trial.
   Hamza Ek, Aras Doğan Ş, Oto A. · · 2026 · PMID 41734419 · DOI 10.1016/j.pedn.2026.02.015