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

Pontificia Universidad Catolica de Chile

Status: Enrolling

Conditions: Dyssomnias

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04995263

0

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Pre-intervention, control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation

Behavioral: Sueña component 1: Sleep Hygiene Promotion

Behavioral: Sueña component 4: Sleep Masks and Ear Plugs

Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening

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

Experimental group

Description:

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

Treatment:

Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation

Behavioral: Sueña component 1: Sleep Hygiene Promotion

Behavioral: Sueña component 4: Sleep Masks and Ear Plugs

Other: Sueña component 5: Personalized Psychoeducation

Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening

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

Experimental group

Description:

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

Treatment:

Device: Sueña component 6: Sleep Reports

Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation

Behavioral: Sueña component 1: Sleep Hygiene Promotion

Behavioral: Sueña component 4: Sleep Masks and Ear Plugs

Other: Sueña component 5: Personalized Psychoeducation

Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening