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| Name | Class |
|---|---|
| UC CHRISTUS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Post-intervention, randomization for SUEÑA full bundle, active group 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Number and Total Duration of Nocturnal Awakenings | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Constanza Caneo Robles, MD | Contact | +56 9 4290 9250 | cmcaneo@uc.cl | |
| Juan C RodrÃguez, MD | Contact | +56 9 4448 9732 | jcrtjcrt@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Constanza Caneo Robles, MD | Pontifica Universidad Católica de Chile | Study Director |
| Juan C RodrÃguez, MD | Pontifica Universidad Católica de Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica San Carlos de Apoquindo UC | Recruiting | Santiago | Santiago Metropolitan | 7550000 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25566173 | Background | 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. | |
| 24164506 | Background |
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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.
January 2024
contact to responsable researcher C Caneo
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Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
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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.
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 |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
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| Change in Mean Number and Total Duration of Naps During the Day | 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. |
| Change in Average Time of Falling Sleep and Awakening | 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. |
| Change in Sleep Architecture | 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. |
| Change in Sleep Onset Latency Mean Duration | 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. |
| Change in REM Onset Latency Mean Duration | 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. |
| Change in Wake After Sleep Onset Mean Duration | 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 | 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. |
| Change in Mean Heart Rate | 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. |
| Change in Mean Number of Steps | 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. |
| Change in Mean Level of Sound | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Measured in days, using data from the participant's medical record. | From day 1 of hospitalization until discharge |
| Change in 30-day Readmission Rate | Measured as a proportion, using data from the participant's medical record and telephonic follow-up. | 30 days after the participant's discharge. |
| Change in Participant Satisfaction Regarding Sleep During Hospitalization | Measurement of the subjective experience of the participant, using telephone surveys. | 7 days after the participant's discharge. |
| Participant Satisfaction Regarding the Intervention | 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 | 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 |
| MarÃa RodrÃguez Fernández, PhD |
| Pontifica Universidad Católica de Chile |
| Study Chair |
| Marcela Babul, MD | Pontifica Universidad Católica de Chile | Study Chair |
| 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. |
| 15023109 | Background | Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. doi: 10.1111/j.1365-2044.2004.03664.x. |
| 22133250 | Background | 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. |
| 30229719 | Background | 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. |
| 26439374 | Background | 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. |
| 27473952 | Background | 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. |
| 29445542 | Background | 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. |
| 29729240 | Background | 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. |
| 23924135 | Background | Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. doi: 10.7748/ns2013.08.27.49.35.e7649. |
| 25700593 | Background | 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. |
| 23999632 | Background | Sandoval-Rincon M, Alcala-Lozano R, Herrera-Jimenez I, Jimenez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish. |
| 29412979 | Background | 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. |
| 24113807 | Background | 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. |
| 19880319 | Background | 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. |
| 11040551 | Background | Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. doi: 10.1097/00044067-200002000-00006. |
| 30014139 | Background | 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. |
| 32329430 | Result | 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. |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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