Pain Management, Pediatric Intensive Care Unit, Non-Pharmacological Interventions, Critical Care Nursing, Pediatric Delirium
Conditions
Keywords
Pediatric Intensive Care, Non-Pharmacological Interventions, Delirium Prevention, Pain Management, Critical Care Nursing
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.
Interventions
OTHEREye 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
OTHEREarplugs
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.
Sponsors
Bozok University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Participants will be randomly assigned to an intervention group (eye mask and earplugs) or a control group (standard nursing care).
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium in Pediatric ICU Patients | 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. |
| Pain Levels in Pediatric ICU Patients | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed