Clinical trial NCT06867523: Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
Official title: The Effect of Eye Masks and Earplugs on Delirium and Pain Prevention in Pediatric Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Delirium in Pediatric ICU Patients
timeFrame: 3 days after intervention
measure: Pain Levels in Pediatric ICU Patients
timeFrame: 3 days after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Bozok University
Study officials:
References: