Multimodal Sleep Promotion in Surgical ICU Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación de investigación HM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Sleep Promotion Intervention
BehavioralThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Multimodal Sleep Promotion InterventionExperimental treatment 1 intervention
Group B: Usual ICU CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
Daily from Day 1 through ICU discharge, up to 7 daysSecondary outcomes
1
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.
Time frame
At ICU discharge, up to 7 days after ICU admission2
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.
Time frame
Daily from Day 1 through ICU discharge, up to 7 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: