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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Wake Disorders; Critical Illness
• Intervention / Treatment: Behavioral: Multimodal Sleep Promotion Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cayetana Ruiz Zaldibar; Phone Number: 695829472; Email: crzaldibar@ucjc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Multimodal 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)	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.	Daily from Day 1 through ICU discharge, up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience Measured by the PPE-33 Questionnaire	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.	At ICU discharge, up to 7 days after ICU admission
Perceived Sleep-Disrupting Factors	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.	Daily from Day 1 through ICU discharge, up to 7 days

Collaborators and Investigators

• Sponsor: Fundación de investigación HM

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Quality; Patient Experience; ICU Patients; Sleep Hygiene; Sleep Promotion; Humanization of Care
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Critical Illness; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Sleep Hygiene
• Other Study ID Numbers: Multisueño_26.03.2668-GHM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No