A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)
2022年9月29日 更新者：Constanza Caneo、Pontificia Universidad Catolica de Chile
A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial
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.
研究概览
地位
招聘中
条件
干预/治疗
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Constanza Caneo Robles, MD
- 电话号码：+56 9 4290 9250
- 邮箱：cmcaneo@uc.cl
研究联系人备份
- 姓名：Juan C Rodríguez, MD
- 电话号码：+56 9 4448 9732
- 邮箱：jcrtjcrt@gmail.com
学习地点
-
-
Región Metropolitana
-
Santiago de Chile、Región Metropolitana、智利、7550000
- 招聘中
- Clínica San Carlos de Apoquindo UC
-
副研究员：
- Pedro Letelier Camus, MD
-
副研究员：
- Simón Medina, MD
-
副研究员：
- Matías Paredes Gálvez, BE
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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.
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|
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实验性的：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. |
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.
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.
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.
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.
|
|
实验性的：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 |
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.
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.
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.
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.
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.
|
|
实验性的：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 |
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.
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.
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.
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.
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.
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Total Sleep Time
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Mean Number and Total Duration of Nocturnal Awakenings
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Mean Number and Total Duration of Naps During the Day
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Average Time of Falling Sleep and Awakening
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Sleep Architecture
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Sleep Onset Latency Mean Duration
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in REM Onset Latency Mean Duration
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Wake After Sleep Onset Mean Duration
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Sleep Efficiency
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Mean Heart Rate
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Mean Number of Steps
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Change in Mean Level of Sound
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Level of Light
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Sleep Quality Perception
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Daytime Sleepiness
大体时间：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).
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Subjective Perception of Sleep-Disturbing Factors
大体时间：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.
|
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
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Systolic and Diastolic Blood Pressure
大体时间：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.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Level of Pain
大体时间：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.
|
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.
|
|
Level of Anxiety
大体时间：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.
|
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 Length of Stay
大体时间：From day 1 of hospitalization until discharge
|
Measured in days, using data from the participant's medical record.
|
From day 1 of hospitalization until discharge
|
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Change in 30-day Readmission Rate
大体时间：30 days after the participant's discharge.
|
Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
|
30 days after the participant's discharge.
|
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Change in Participant Satisfaction Regarding Sleep During Hospitalization
大体时间：7 days after the participant's discharge.
|
Measurement of the subjective experience of the participant, using telephone surveys.
|
7 days after the participant's discharge.
|
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Participant Satisfaction Regarding the Intervention
大体时间：7 days after the participant's discharge.
|
Measurement of the subjective experience of participants, using telephone surveys.
|
7 days after the participant's discharge.
|
|
Health Personnel Satisfaction and Agreeability Regarding the Intervention
大体时间：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.
|
Every 3 months through study completion, an average of 1.5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Constanza Caneo Robles, MD、Pontifica Universidad Catolica De Chile
- 研究主任：Juan C Rodríguez, MD、Pontifica Universidad Catolica De Chile
- 学习椅：María Rodríguez Fernández, PhD、Pontifica Universidad Catolica De Chile
- 学习椅：Marcela Babul, MD、Pontifica Universidad Catolica De Chile
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108.
- Tembo AC, Parker V. Factors that impact on sleep in intensive care patients. Intensive Crit Care Nurs. 2009 Dec;25(6):314-22. doi: 10.1016/j.iccn.2009.07.002. Epub 2009 Oct 31.
- Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.
- Bano M, Chiaromanni F, Corrias M, Turco M, De Rui M, Amodio P, Merkel C, Gatta A, Mazzotta G, Costa R, Montagnese S. The influence of environmental factors on sleep quality in hospitalized medical patients. Front Neurol. 2014 Dec 11;5:267. doi: 10.3389/fneur.2014.00267. eCollection 2014.
- Bernhofer EI, Higgins PA, Daly BJ, Burant CJ, Hornick TR. Hospital lighting and its association with sleep, mood and pain in medical inpatients. J Adv Nurs. 2014 May;70(5):1164-73. doi: 10.1111/jan.12282. Epub 2013 Oct 27.
- Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. Review.
- Denkinger MD, Lindemann U, Nicolai S, Igl W, Jamour M, Nikolaus T. Assessing Physical Activity in Inpatient Rehabilitation: validity, practicality, and sensitivity to change in the physical activity in inpatient rehabilitation assessment. Arch Phys Med Rehabil. 2011 Dec;92(12):2012-7. doi: 10.1016/j.apmr.2011.06.032.
- Horne S, Hay K, Watson S, Anderson KN. An evaluation of sleep disturbance on in-patient psychiatric units in the UK. BJPsych Bull. 2018 Oct;42(5):193-197. doi: 10.1192/bjb.2018.42.
- Lawrence G, Muza R. Assessing the sleeping habits of patients in a sleep disorder centre: a review of sleep diary accuracy. J Thorac Dis. 2018 Jan;10(Suppl 1):S177-S183. doi: 10.21037/jtd.2017.12.127.
- Milani RV, Bober RM, Lavie CJ, Wilt JK, Milani AR, White CJ. Reducing Hospital Toxicity: Impact on Patient Outcomes. Am J Med. 2018 Aug;131(8):961-966. doi: 10.1016/j.amjmed.2018.04.013. Epub 2018 May 3.
- Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. Review.
- Rodriguez JC, Dzierzewski JM, Alessi CA. Sleep problems in the elderly. Med Clin North Am. 2015 Mar;99(2):431-9. doi: 10.1016/j.mcna.2014.11.013. Epub 2014 Dec 30. Review.
- Sandoval-Rincón M, Alcalá-Lozano R, Herrera-Jiménez I, Jiménez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish.
- Stewart NH, Arora VM. Sleep in Hospitalized Older Adults. Sleep Med Clin. 2018 Mar;13(1):127-135. doi: 10.1016/j.jsmc.2017.09.012. Epub 2017 Nov 10. Review.
- Tamrat R, Huynh-Le MP, Goyal M. Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014 May;29(5):788-95. doi: 10.1007/s11606-013-2640-9. Epub 2013 Oct 10.
- Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. Review.
- Wesselius HM, van den Ende ES, Alsma J, Ter Maaten JC, Schuit SCE, Stassen PM, de Vries OJ, Kaasjager KHAH, Haak HR, van Doormaal FF, Hoogerwerf JJ, Terwee CB, van de Ven PM, Bosch FH, van Someren EJW, Nanayakkara PWB; "Onderzoeks Consortium Acute Geneeskunde" Acute Medicine Research Consortium. Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients. JAMA Intern Med. 2018 Sep 1;178(9):1201-1208. doi: 10.1001/jamainternmed.2018.2669.
- Novak C, Packer E, Paterson A, Roshi A, Locke R, Keown P, Watson S, Anderson KN. Feasibility and utility of enhanced sleep management on in-patient psychiatry wards. BJPsych Bull. 2020 Dec;44(6):255-260. doi: 10.1192/bjb.2020.30.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月22日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2023年8月1日
研究注册日期
首次提交
2021年7月22日
首先提交符合 QC 标准的
2021年7月31日
首次发布 (实际的)
2021年8月6日
研究记录更新
最后更新发布 (实际的)
2022年9月30日
上次提交的符合 QC 标准的更新
2022年9月29日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 其他标识符：No secondary ID
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.
IPD 共享时间框架
January 2024
IPD 共享访问标准
contact to responsable researcher C Caneo
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.