Recherche en soins infirmiers · 2026
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Протокол клинического исследованияАннотация на английскомСтатьяНазвание и аннотация: Перевод в очереди
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Crozes Fanny, Seailles Séverine, Planton Mélanie, Lepage M, Quintard Martine, Huo Yung Kai Samantha, Silva Stein, Haubertin Carole
Аннотация
BACKGROUND: Delirium is a frequent and serious complication in intensive care units (ICUs), with reported incidence rates ranging from 3.6% to 83.3% and affecting up to 40% of ICU patients. It is associated with adverse patient outcomes. Despite the available evidence, implementation in routine clinical practice remains challenging. Publishing this protocol also aims to disseminate evidence-based practices.
OBJECTIVES: This study protocol aims to evaluate the effectiveness of a standardized bundle of nonpharmacological interventions in reducing the incidence and duration of delirium among ICU patients. Secondary objectives include the assessment of delirium duration, neuropsychological outcomes at three months, and health-related quality of life one year after ICU discharge. The protocol was developed in accordance with SPIRIT 2025 recommendations, and the trial was registered under the identifier NCT03125252.
METHODS: This is a multicenter, cluster- randomized controlled trial involving 14 intensive care units stratified by unit size. Cluster randomization was performed, and the required sample size was estimated at 474 patients in order to detect a 19% reduction in delirium incidence. The intervention group received a bundle including environmental modifications, conversational hypnosis, and patient empowerment techniques, while the control group received regular care. Delirium was assessed twice daily using the validated CAM-ICU tool.
EXPECTED RESULTS: This protocol aims to reduce delirium incidence through preventive and patient-centered ICU care. Delirium duration, neuropsychological outcomes, and quality of life will also be evaluated. In addition, this study provides practical evidence-based guidance for healthcare teams to implement specific delirium prevention interventions.
OBJECTIVES: This study protocol aims to evaluate the effectiveness of a standardized bundle of nonpharmacological interventions in reducing the incidence and duration of delirium among ICU patients. Secondary objectives include the assessment of delirium duration, neuropsychological outcomes at three months, and health-related quality of life one year after ICU discharge. The protocol was developed in accordance with SPIRIT 2025 recommendations, and the trial was registered under the identifier NCT03125252.
METHODS: This is a multicenter, cluster- randomized controlled trial involving 14 intensive care units stratified by unit size. Cluster randomization was performed, and the required sample size was estimated at 474 patients in order to detect a 19% reduction in delirium incidence. The intervention group received a bundle including environmental modifications, conversational hypnosis, and patient empowerment techniques, while the control group received regular care. Delirium was assessed twice daily using the validated CAM-ICU tool.
EXPECTED RESULTS: This protocol aims to reduce delirium incidence through preventive and patient-centered ICU care. Delirium duration, neuropsychological outcomes, and quality of life will also be evaluated. In addition, this study provides practical evidence-based guidance for healthcare teams to implement specific delirium prevention interventions.