Идёт набор NCT07441668

Comfort Intervention in PICU Children

Без фазы С лечением Pediatric Intensive Care Unit Comfort Anxiety in Children Fear

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Intervention Family-Centered Comfort, Standard Care (in control arm).
Кому может быть актуально: Состояния в реестре: Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear. Базовые параметры: 5 лет — 10 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial

Обзор

This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.

Подробное описание

This randomized controlled trial will be conducted in a PICU to evaluate the effectiveness of a family-centered comfort intervention based on Kolcaba's Comfort Theory. Eligible children and their parents will be enrolled after consent and randomly assigned to an intervention group or a control group.

The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket.

Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.

Вмешательства

Поведенческое Intervention Family-Centered Comfort
Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Другое Standard Care (in control arm)
Routine care provided to children in the control group without additional comfort interventions.

Первичные конечные точки

COMFORT-B Behavioral Comfort Scale Total Score (6-30) [Срок оценки: Baseline; 24 hours after admission; 12 hours after intervention]

Вторичные конечные точки (7)

Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4) [Срок оценки: Baseline; 24 hours after admission; 12 hours after intervention]
Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10) [Срок оценки: Baseline; 24 hours after admission; 12 hours after intervention]
Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80) [Срок оценки: Baseline; 12 hours after intervention]
Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100) [Срок оценки: 24 hours after admission; 12 hours after intervention]
Total Sleep Duration Measured by Wrist Actigraphy (minutes) [Срок оценки: 24 hours after admission; 12 hours after intervention]
Number of Night Awakenings Measured by Wrist Actigraphy (count) [Срок оценки: 24 hours after admission; 12 hours after intervention]
Sleep Efficiency Measured by Wrist Actigraphy (%) [Срок оценки: 24 hours after admission; 12 hours after intervention]

Критерии участия

Критерии включения

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