Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07441668
Eligibility Criteria:
Inclusion Criteria:
* Child aged 5-10 years
* Has not received intravenous sedation or anesthetic medication in the past 12 hours
* Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
* Conscious and able to communicate
* Glasgow Coma Scale score of 15
* No pain as assessed by the Wong-Baker FACES Pain Rating Scale
* Written informed consent obtained from parent/legal guardian
* Child and parent able to communicate in Turkish
* No medical contraindications to non-pharmacological, non-interactive interventions
Exclusion Criteria:
* Mechanically ventilated or intubated
* Hearing impairment
* Visual impairment
* Hand motor limitations
* Severe or profound intellectual disability
* Epilepsy or history of seizures
* Severe underweight
* Chronic respiratory disease
* Chronic cardiovascular disease
* Surgical implants
* Osteoporosis
* Diagnosis of sleep disorder
* Use of sleep medication
* Any physical or mental health condition that prevents communication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
10 Years
Study:
NCT07441668
Study Brief:
Protocol Section:
NCT07441668