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Multimodal Sleep Promotion in Surgical ICU Patients (MULTISLEEP)

15 juli 2026 bijgewerkt door: Fundación de investigación HM

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sleep Quality Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Tijdsspanne: 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.
Daily from Day 1 through ICU discharge, up to 7 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Experience Measured by the PPE-33 Questionnaire
Tijdsspanne: 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.
At ICU discharge, up to 7 days after ICU admission
Perceived Sleep-Disrupting Factors
Tijdsspanne: 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.
Daily from Day 1 through ICU discharge, up to 7 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fundación de investigación HM

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 december 2026

Studie voltooiing (Geschat)

30 januari 2027

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Multisueño_26.03.2668-GHM

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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