A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit
- Conditions
- Dyssomnias
- Registration Number
- NCT04995263
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Hospitalized in the last 72 hours.
- Capacity to consent
- Approval by treating physician
- Active psychosis
- Active eating disorder
- Delirium
- Major cognitive disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Change in Total Sleep Time From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
- Secondary Outcome Measures
Name Time Method Change in Mean Number and Total Duration of Nocturnal Awakenings From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Level of Anxiety 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.
Change in Mean Number and Total Duration of Naps During the Day From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Sleep Efficiency From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Mean Heart Rate From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.
Change in Mean Number of Steps From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices.
Change in Sleep Onset Latency Mean Duration From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Wake After Sleep Onset Mean Duration From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Average Time of Falling Sleep and Awakening From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Sleep Architecture From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Change in Mean Level of Sound From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.
Change in Mean Level of Light From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured in lux, using objective data registered by a lux meter placed in the participant's rooms.
Changes in Daytime Sleepiness From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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).
Changes in Subjective Perception of Sleep-Disturbing Factors From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Level of Pain 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 Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.
Change in 30-day Readmission Rate 30 days after the participant's discharge. Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
Change in Participant Satisfaction Regarding Sleep During Hospitalization 7 days after the participant's discharge. Measurement of the subjective experience of the participant, using telephone surveys.
Health Personnel Satisfaction and Agreeability Regarding the Intervention Every 3 months through study completion, an average of 1.5 years Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.
Change in REM Onset Latency Mean Duration From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. 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.
Changes in Sleep Quality Perception From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.
Changes in Pharmacological Indications and Need of SOS Medication From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.
Changes in Systolic and Diastolic Blood Pressure From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.
Change in Mean Length of Stay From day 1 of hospitalization until discharge Measured in days, using data from the participant's medical record.
Participant Satisfaction Regarding the Intervention 7 days after the participant's discharge. Measurement of the subjective experience of participants, using telephone surveys.
Trial Locations
- Locations (1)
ClÃnica San Carlos de Apoquindo UC
🇨🇱Santiago de Chile, Región Metropolitana, Chile