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

January 31, 2026 updated by: Şenay ARAS DOĞAN, Bozok University

The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eye Mask & Earplugs
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
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
Other: Earplugs
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.
No Intervention: Standard Nursing Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Delirium in Pediatric ICU Patients
Time Frame: 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.
3 days after intervention
Pain Levels in Pediatric ICU Patients
Time Frame: 3 days after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-14/15
  • THD-2025-1489 (Other Grant/Funding Number: Bozok University Scientific Research Projects Unit (BAP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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