A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Total Sleep Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in the last 72 hours.
- •Capacity to consent
- •Approval by treating physician
排除标准
- •Active psychosis
- •Active eating disorder
- •Major cognitive disorder
研究组 & 干预措施
Pre-intervention, control group
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
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.
干预措施: Sueña component 1: Sleep Hygiene Promotion (Behavioral)
Post-intervention, SUEÑA half bundle, active group 1
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.
干预措施: Sueña component 2: Periodic Anxiety and Pain Screening (Behavioral)
Post-intervention, SUEÑA half bundle, active group 1
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.
干预措施: Sueña component 3: Hypnotics and Caffeine Regulation (Behavioral)
Post-intervention, SUEÑA half bundle, active group 1
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.
干预措施: Sueña component 4: Sleep Masks and Ear Plugs (Behavioral)
Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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
干预措施: Sueña component 1: Sleep Hygiene Promotion (Behavioral)
Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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
干预措施: Sueña component 2: Periodic Anxiety and Pain Screening (Behavioral)
Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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
干预措施: Sueña component 3: Hypnotics and Caffeine Regulation (Behavioral)
Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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
干预措施: Sueña component 4: Sleep Masks and Ear Plugs (Behavioral)
Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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
干预措施: Sueña component 5: Personalized Psychoeducation (Other)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 1: Sleep Hygiene Promotion (Behavioral)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 2: Periodic Anxiety and Pain Screening (Behavioral)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 3: Hypnotics and Caffeine Regulation (Behavioral)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 4: Sleep Masks and Ear Plugs (Behavioral)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 5: Personalized Psychoeducation (Other)
Post-intervention, randomization for SUEÑA full bundle, active group 3
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
干预措施: Sueña component 6: Sleep Reports (Device)
结局指标
主要结局
Change in Total Sleep Time
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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 Sleep Efficiency(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Change in Mean Heart Rate(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Change in Mean Number of Steps(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.)
- Change in Wake After Sleep Onset Mean Duration(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 Mean Level of Sound(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Change in Mean Level of Light(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Changes in Daytime Sleepiness(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Changes in Subjective Perception of Sleep-Disturbing Factors(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- 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.)
- Change in 30-day Readmission Rate(30 days after the participant's discharge.)
- Change in Participant Satisfaction Regarding Sleep During Hospitalization(7 days after the participant's discharge.)
- Health Personnel Satisfaction and Agreeability Regarding the Intervention(Every 3 months through study completion, an average of 1.5 years)
- Change in REM Onset Latency Mean Duration(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Changes in Sleep Quality Perception(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- 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.)
- Changes in Systolic and Diastolic Blood Pressure(From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.)
- Change in Mean Length of Stay(From day 1 of hospitalization until discharge)
- Participant Satisfaction Regarding the Intervention(7 days after the participant's discharge.)
研究者
Constanza Caneo
Clinical Assistant Professor, C-L Psychiatrist, SUEÑA Director
Pontificia Universidad Catolica de Chile