Critical Illness, Sleep Wake Disorders
Conditions
Keywords
Sleep Quality, ICU Patients, Sleep Promotion, Sleep Hygiene, Patient Experience, Humanization of Care
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALMultimodal Sleep Promotion Intervention
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.
Sponsors
Fundación de investigación HM
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality Measured by the Richards-Campbell Sleep Questionnaire (RCSQ) | Daily from Day 1 through ICU discharge, up to 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience Measured by the PPE-33 Questionnaire | At ICU discharge, up to 7 days after ICU admission | 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. |
| Perceived Sleep-Disrupting Factors | Daily from Day 1 through ICU discharge, up to 7 days | 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. |
Contacts
CONTACTCayetana Ruiz Zaldibar
Outcome results
None listed