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Not Yet Recruiting NCT07672509

Multimodal Sleep Promotion in Surgical ICU Patients

Conditions: Sleep Wake Disorders, Critical Illness

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Fundación de investigación HM

Summary

Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction. Environmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited. This two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care. The primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.

Eligibility Criteria

Inclusion Criteria: * Adult patients aged 18 years or older. * Patients admitted to an adult intensive care unit after surgery. * Expected ICU stay of at least one night. * Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments. * Patients able to understand and complete the questionnaires, either independently or with minimal assistance. * Patients without language barriers that prevent study participation. Exclusion Criteria: * Patients with acute neurological impairment or moderate to severe cognitive dysfunction. * Patients receiving invasive mechanical ventilation with ongoing sedation. * Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting. * Patients unable to provide questionnaire responses due to communication limitations or clinical condition. * Patients with language barriers preventing participation in study procedures and completion of study assessments

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07672509). StuddyBuddy aggregates publicly available trial information.