A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)

A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit

A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial

Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.

Sleep, Psychiatric Intensive Care Unit, Multicomponent Intervention, Wearable Activity Tracker, Behavioral Intervention, Psychoeducation, Environmental Interventions

Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.

Two investigators will work on-site collecting data for each of the variables, uploading them to a secure database (REDCap) as anonymous data. Afterwards, data and outcomes will be analyzed by a blinded investigator.

A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention. Estimated duration 3 months, n = 30.

Post-intervention, environmental and behavioral modifications in patient care interventions. Implementation of components 1 through 4 of SUEÑA intervention in the entire PICU unit. All participants will be exposed to the intervention. Estimated duration: 3 months, n = 30.

Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment. Participants will be randomized to receive SUEÑA components 1 through 5 Estimated duration: 6 months, n = 30

Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment and personalized psychoeducation. . Participants will be randomized to receive SUEÑA components 1 through 6. Estimated duration: 6 months, n = 30

The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.

Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.

The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.

Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.

Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.

Objective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management

Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables.

Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.

Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.

Measured in time of day in 24-hour notation, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.

Measured in minutes of total duration for each sleep phase (awake, light sleep, deep sleep and REM) and as a relative value of the total sleep time, using objective data measured by Fitbit Charge 4 devices.

Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered sleep phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.

Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered REM phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.

Measured in minutes of total time spent awake from the time of the first registered sleep phase to the time of the last registered awakening, using objective data measured by Fitbit Charge 4 devices.

Measured in percentage of total time spent sleeping at night, calculated as total sleep time divided by total time spent in bed, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.

Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.

Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.

Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.

Measured using the Epworth Sleepiness Scale (ESS), which considers 8 hypothetical situations and scores the likelihood of falling asleep from 0 to 3, and registers a total aggregated score (with a maximum total score of 24).

Measured using complementary questions regarding the presence/absence of factors (either environmental, symptomatological, or other) and their identification using predefined options: excessive light, excessive noise, interactions with health personnel, pain, anxiety, or others. In case of selecting "others", a text field will be available for its description.

Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.

Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.

Measured with a Visual Analog Scale for Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.

From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.

Measured with a Visual Analog Scale for Anxiety (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.

From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.

Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.

Inclusion Criteria: Hospitalized in the last 72 hours. Capacity to consent Approval by treating physician Exclusion Criteria: Active psychosis Active eating disorder Delirium Major cognitive disorder

We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.

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