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.
調査の概要
状態
募集
条件
介入・治療
研究の種類
介入
入学 (予想される)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Constanza Caneo Robles, MD
- 電話番号：+56 9 4290 9250
- メール：cmcaneo@uc.cl
研究連絡先のバックアップ
- 名前：Juan C Rodríguez, MD
- 電話番号：+56 9 4448 9732
- メール：jcrtjcrt@gmail.com
研究場所
-
-
Región Metropolitana
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Santiago de Chile、Región Metropolitana、チリ、7550000
- 募集
- Clínica San Carlos de Apoquindo UC
-
副調査官：
- Pedro Letelier Camus, MD
-
副調査官：
- Simón Medina, MD
-
副調査官：
- Matías Paredes Gálvez, BE
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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.
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実験的：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.
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|
実験的：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Total Sleep Time
時間枠：From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Mean Number and Total Duration of Nocturnal Awakenings
時間枠：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
時間枠：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.
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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
時間枠：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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Sleep Architecture
時間枠：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.
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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
時間枠：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.
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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
時間枠：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.
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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
時間枠：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.
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Change in Sleep Efficiency
時間枠：From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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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
時間枠：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
時間枠：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
時間枠：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.
|
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Change in Mean Level of Light
時間枠：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.
|
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Changes in Sleep Quality Perception
時間枠：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.
|
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Changes in Daytime Sleepiness
時間枠：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).
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Changes in Subjective Perception of Sleep-Disturbing Factors
時間枠：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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
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Changes in Pharmacological Indications and Need of SOS Medication
時間枠：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.
|
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Changes in Systolic and Diastolic Blood Pressure
時間枠：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.
|
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Level of Pain
時間枠：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.
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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.
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Level of Anxiety
時間枠：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.
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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.
|
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Change in Mean Length of Stay
時間枠：From day 1 of hospitalization until discharge
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Measured in days, using data from the participant's medical record.
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From day 1 of hospitalization until discharge
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Change in 30-day Readmission Rate
時間枠：30 days after the participant's discharge.
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Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
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30 days after the participant's discharge.
|
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Change in Participant Satisfaction Regarding Sleep During Hospitalization
時間枠：7 days after the participant's discharge.
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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
時間枠：7 days after the participant's discharge.
|
Measurement of the subjective experience of participants, using telephone surveys.
|
7 days after the participant's discharge.
|
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Health Personnel Satisfaction and Agreeability Regarding the Intervention
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- スタディディレクター：Constanza Caneo Robles, MD、Pontifica Universidad Catolica de Chile
- スタディディレクター：Juan C Rodríguez, MD、Pontifica Universidad Catolica de Chile
- スタディチェア：María Rodríguez Fernández, PhD、Pontifica Universidad Catolica de Chile
- スタディチェア：Marcela Babul, MD、Pontifica Universidad Catolica de Chile
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年6月22日
一次修了 (予想される)
2022年12月1日
研究の完了 (予想される)
2023年8月1日
試験登録日
最初に提出
2021年7月22日
QC基準を満たした最初の提出物
2021年7月31日
最初の投稿 (実際)
2021年8月6日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月30日
QC基準を満たした最後の更新が送信されました
2022年9月29日
最終確認日
2022年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Institute of Psychiatry
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
January 2024
IPD 共有アクセス基準
contact to responsable researcher C Caneo
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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