NCT04995263

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyssomnias

Interventions

Type	Name	Description
BEHAVIORAL	Sueña component 1: Sleep Hygiene Promotion	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.
BEHAVIORAL	Sueña component 2: Periodic Anxiety and Pain Screening	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.
BEHAVIORAL	Sueña component 3: Hypnotics and Caffeine Regulation	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.
BEHAVIORAL	Sueña component 4: Sleep Masks and Ear Plugs	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.
OTHER	Sueña component 5: Personalized Psychoeducation	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.
DEVICE	Sueña component 6: Sleep Reports	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

Timeline

• Start date: 2021-06-22
• Primary completion: 2022-12-01
• Completion: 2023-08-01
• First posted: 2021-08-06
• Last updated: 2022-09-30

Locations

1 site across 1 country: Chile