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

NCT04995263 | Unknown

• 1 other identifier: 0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyssomnias

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Total Sleep Time

  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.

  From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.

Secondary Outcomes (24)

• 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.

• 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.

• 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.

• Change in Sleep Architecture

  From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.

• Change in Sleep Onset Latency Mean Duration

  From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.

Study Arms (4)

Pre-intervention, control group

NO INTERVENTION

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, SUEÑA half bundle, active group 1

EXPERIMENTAL

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.

Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs

Post-intervention, randomization for SUEÑA half bundle plus, active group 2

EXPERIMENTAL

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

Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs; Other: Sueña component 5: Personalized Psychoeducation

Post-intervention, randomization for SUEÑA full bundle, active group 3

EXPERIMENTAL

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

Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs; Other: Sueña component 5: Personalized Psychoeducation; Device: Sueña component 6: Sleep Reports

Interventions

Sueña component 1: Sleep Hygiene Promotion BEHAVIORAL

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.

Post-intervention, SUEÑA half bundle, active group 1; Post-intervention, randomization for SUEÑA full bundle, active group 3; Post-intervention, randomization for SUEÑA half bundle plus, active group 2

Sueña component 2: Periodic Anxiety and Pain Screening BEHAVIORAL

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.

Post-intervention, SUEÑA half bundle, active group 1; Post-intervention, randomization for SUEÑA full bundle, active group 3; Post-intervention, randomization for SUEÑA half bundle plus, active group 2

Sueña component 3: Hypnotics and Caffeine Regulation BEHAVIORAL

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.

Post-intervention, SUEÑA half bundle, active group 1; Post-intervention, randomization for SUEÑA full bundle, active group 3; Post-intervention, randomization for SUEÑA half bundle plus, active group 2

Sueña component 4: Sleep Masks and Ear Plugs BEHAVIORAL

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.

Post-intervention, SUEÑA half bundle, active group 1; Post-intervention, randomization for SUEÑA full bundle, active group 3; Post-intervention, randomization for SUEÑA half bundle plus, active group 2

Sueña component 5: Personalized Psychoeducation OTHER

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.

Post-intervention, randomization for SUEÑA full bundle, active group 3; Post-intervention, randomization for SUEÑA half bundle plus, active group 2

Sueña component 6: Sleep Reports DEVICE

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

Post-intervention, randomization for SUEÑA full bundle, active group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in the last 72 hours.
• Capacity to consent
• Approval by treating physician

You may not qualify if:

• Active psychosis
• Active eating disorder
• Delirium
• Major cognitive disorder

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• UC CHRISTUS: collaborator

Study Sites (1)

Clínica San Carlos de Apoquindo UC

Santiago, Santiago Metropolitan, 7550000, Chile

RECRUITING

Related Publications (18)

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  PMID: 32329430 RESULT

MeSH Terms

Conditions

Dyssomnias

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Constanza Caneo Robles, MD

  Pontifica Universidad Católica de Chile

  STUDY DIRECTOR

• Juan C Rodríguez, MD

  Pontifica Universidad Católica de Chile

  STUDY DIRECTOR

• María Rodríguez Fernández, PhD

  Pontifica Universidad Católica de Chile

  STUDY CHAIR

• Marcela Babul, MD

  Pontifica Universidad Católica de Chile

  STUDY CHAIR

Central Study Contacts

Constanza Caneo Robles, MD

CONTACT

+56 9 4290 9250; cmcaneo@uc.cl

Juan C Rodríguez, MD

CONTACT

+56 9 4448 9732; jcrtjcrt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, C-L Psychiatrist, SUEÑA Director

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

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 6, 2021
• Study Start: June 22, 2021
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2024
• Access Criteria: contact to responsable researcher C Caneo

Locations

CL (1)