Multimodal Sleep Promotion in Surgical ICU Patients

NCT07672509 | Not Yet Recruiting

• 1 other identifier: Multisueño_26.03.2668-GHM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness; Sleep Wake Disorders

Keywords

Sleep Quality; ICU Patients; Sleep Promotion; Sleep Hygiene; Patient Experience; Humanization of Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Experience Measured by the PPE-33 Questionnaire

  At ICU discharge, up to 7 days after ICU admission

• Perceived Sleep-Disrupting Factors

  Daily from Day 1 through ICU discharge, up to 7 days

Study Arms (2)

Multimodal Sleep Promotion Intervention

EXPERIMENTAL

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

Usual ICU Care

NO INTERVENTION

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.

Interventions

Multimodal Sleep Promotion Intervention BEHAVIORAL

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.

Multimodal Sleep Promotion Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación de investigación HM: lead

Related Publications (3)

• Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.

  PMID: 11227580 RESULT

• 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.

  PMID: 25594808 RESULT

• 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.

  PMID: 29454739 RESULT

MeSH Terms

Conditions

Sleep Wake Disorders; Critical Illness; Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes; Sleep Disorders, Intrinsic; Dyssomnias; Health Behavior; Behavior

Central Study Contacts

Cayetana Ruiz Zaldibar

CONTACT

695829472; crzaldibar@ucjc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share