Multimodal Sleep Promotion in Surgical ICU Patients (MULTISLEEP)
Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sleep disruption is highly prevalent among critically ill patients admitted to intensive care units (ICUs). Previous studies have demonstrated that ICU patients frequently experience fragmented sleep, reduced deep sleep, and disruption of circadian rhythms. Poor sleep quality in the ICU has been associated with adverse outcomes, including delirium, impaired recovery, reduced patient satisfaction, and decreased overall well-being.
Multiple factors contribute to sleep disturbances in the ICU, including environmental noise, continuous light exposure, frequent nighttime nursing interventions, pain, discomfort associated with medical devices, and psychological distress. Although several non-pharmacological interventions have been evaluated individually, such as earplugs, eye masks, environmental modifications, and relaxation strategies, evidence regarding comprehensive multimodal approaches remains limited.
The purpose of this study is to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, use of earplugs and eye masks, environmental measures aimed at reducing noise and light exposure, and optimization of nursing care to minimize unnecessary nighttime interruptions.
This study is designed as a two-center, non-randomized controlled pilot study conducted in two adult ICUs within the same healthcare organization. One ICU will implement the multimodal sleep promotion intervention, while the second ICU will provide usual care. The study will assess patient-reported sleep quality and patient experience measures, as well as explore the influence of selected demographic and clinical characteristics on study outcomes.
The results of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of a multimodal sleep promotion strategy and will inform the design of future larger-scale controlled studies in critically ill populations.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cayetana Ruiz Zaldibar
- Número de teléfono: 695829472
- Correo electrónico: crzaldibar@ucjc.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Multimodal Sleep Promotion Intervention
Participants admitted to the intervention ICU will receive a multimodal sleep promotion program consisting of individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and optimization of nursing care activities to minimize unnecessary sleep interruptions during the ICU stay.
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The multimodal sleep promotion intervention consists of four components: (1) individualized sleep hygiene education, including information on sleep physiology, the importance of minimizing nighttime disturbances, and strategies to improve sleep during ICU stay; (2) provision and encouragement of nighttime use of earplugs and an eye mask; (3) environmental modifications aimed at reducing noise, light exposure, and thermal discomfort during the night; and (4) optimization of nursing care activities by clustering non-urgent procedures and minimizing avoidable nighttime interruptions.
The intervention is delivered throughout the ICU stay according to a structured sleep promotion protocol.
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Sin intervención: Usual ICU Care
Participants admitted to the control ICU will receive usual intensive care unit care without implementation of the structured multimodal sleep promotion program.
Any sleep-related measures provided as part of routine clinical practice will be documented.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sleep Quality Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Periodo de tiempo: Daily from Day 1 through ICU discharge, up to 7 days
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Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported measure specifically developed for critically ill patients.
The questionnaire consists of five visual analog scale items ranging from 0 to 100, with higher scores indicating better perceived sleep quality.
The primary outcome will be the mean RCSQ score.
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Daily from Day 1 through ICU discharge, up to 7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient Experience Measured by the PPE-33 Questionnaire
Periodo de tiempo: At ICU discharge, up to 7 days after ICU admission
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Patient experience will be assessed using the validated Spanish version of the Picker Patient Experience Questionnaire (PPE-33).
Higher scores indicate a more positive patient experience during hospitalization.
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At ICU discharge, up to 7 days after ICU admission
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Perceived Sleep-Disrupting Factors
Periodo de tiempo: Daily from Day 1 through ICU discharge, up to 7 days
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Patient-reported impact of environmental and clinical factors on sleep, including noise, light, nursing interventions, pain, anxiety, lack of privacy, temperature, and discomfort, measured using visual analogue scales ranging from 0 to 100.
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Daily from Day 1 through ICU discharge, up to 7 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Bertran MJ, Vinaras M, Salamero M, Garcia F, Graham C, McCulloch A, Escarrabill J. Spanish and Catalan translation, cultural adaptation and validation of the Picker Patient Experience Questionnaire-15. J Healthc Qual Res. 2018 Jan-Feb;33(1):10-17. doi: 10.1016/j.cali.2017.12.004. Epub 2018 Feb 14.
- Pisani MA, Friese RS, Gehlbach BK, Schwab RJ, Weinhouse GL, Jones SF. Sleep in the intensive care unit. Am J Respir Crit Care Med. 2015 Apr 1;191(7):731-8. doi: 10.1164/rccm.201411-2099CI.
- Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Procesos Patológicos
- Atributos de la enfermedad
- Trastornos del Sueño Intrínsecos
- Disomnias
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Comportamiento de salud
- Enfermedad crítica
- Trastornos de iniciación y mantenimiento del sueño
- Trastornos del sueño y la vigilia
- Higiene del sueño
Otros números de identificación del estudio
- Multisueño_26.03.2668-GHM
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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