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Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases

Primary Purpose

Sleep Hygiene

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Hygiene focused on measuring Sleep Deprivation, Intensive Care Units

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age over 18 years.
  2. Have the ability to communicate verbally and understand what is requested in the assessment instruments, according to the nurse's initial assessment performed on admission.

Exclusion Criteria:

  1. Report of a serious sleep disorder that requires daily treatment before hospitalization, such as sleep apnea, narcolepsy and chronic insomnia.
  2. Presence of severe complication (aortic dissection, bleeding or stroke after the procedure) related to the treatment.
  3. Presence of delirium as assessed in the medical record.
  4. Severe hearing and visual loss.
  5. History of neurological disease or diagnosed psychiatric disorders.
  6. Admission to the Intensive Care Unit between the hours of 9:00 pm to 6:00 am after the percutaneous intervention procedure.
  7. Treatment with mechanical ventilation.
  8. Need for sedation while in the ICU.
  9. Who are not fluent in the Portuguese language.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.

    Participants will not use the devices at any time of admission to the intensive care unit

    Outcomes

    Primary Outcome Measures

    Sleep quality
    Sleep quality will be assessed by the visual sleep scale, adapted and validated in Brazil from the original instrument Verran Snyder-Halpern Sleep Scale that allows daily self-assessment of the sleep efficiency of hospitalized patients regarding their last night of slep

    Secondary Outcome Measures

    Sleepiness
    The Epworth Excessive Sleepiness Scale (ESS) will be used in the morning to allow the patient to self-assess the outcome

    Full Information

    First Posted
    January 13, 2021
    Last Updated
    January 15, 2021
    Sponsor
    Hospital Sirio-Libanes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04716491
    Brief Title
    Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases
    Official Title
    Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    March 31, 2021 (Anticipated)
    Study Completion Date
    April 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Sirio-Libanes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients undergoing treatment for heart disease through percutaneous interventions admitted to intensive care units often suffer from sleep deprivation, with multifactorial factors being the precursors of this problem. Sleep deprivation has a negative impact on rehabilitation, with increased morbidity and mortality. Therefore, implementing non-pharmacological measures for this population is essential for better quality care, as well as more satisfactory experiences. The Objectives are to evaluate whether the non-pharmacological intervention that includes the use of eye masks and hearing protectors has an influence on the quality of sleep of patients undergoing percutaneous interventions for the treatment of heart diseases admitted to the intensive care unit, to compare the quality of sleep between patients according to sociodemographic and clinical variables and to identify whether anxiety is a factor associated with sleep quality in patients undergoing percutaneous interventions for the treatment of heart disease in patients admitted to the intensive care unit. Randomized clinical trial blinded to the steps of data collection and data analysis, with two groups of participants in which the intervention with eye masks and ear protectors will be evaluated. The inclusion criteria in the study will be patients undergoing percutaneous intervention treatment for heart disease over the age of 18, preserved communication skills and understanding. The study site will be a cardiac intensive care unit in a private hospital of high complexity in the city of São Paulo. The intervention will be carried out during the period of hospitalization in the intensive care unit, by nurses trained by the researcher from 9 pm until the patient awakens, and variables related to sleep quality, anxiety, pain, delirium and length of stay will be collected. in bed. The sample will consist of 80 patients divided into two groups (intervention and control) and the data will be analyzed with descriptive statistics, with Student t test and Mann Whitney test for comparison between groups and with Chi-square test and Spearman for analysis of categorical variables. . Relative risk, odds ratio will be calculated and the level of significance adopted will be 5%. It is intended to know if the non-pharmacological intervention brings benefits to reduce sleep deprivation and contributes to better clinical outcomes.
    Detailed Description
    The intervention to promote sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU will be the use of ear protectors and eye masks. The purpose of the intervention is to promote sleep in this population by reducing noise and light in the Intensive Care Unit environment. The devices used will be the use of black silk masks with elastic for protection of the eyes against light and a silicone ear protector to reduce environmental noise. The procedure will consist of the following steps: application of the free and informed consent form, sleep assessment instruments, trait and state anxiety and collection of sociodemographic and clinical data and randomization in the arms of the study at the patient's admission to the ICU, guidance on the use of devices from 21 hours and until awakening, measurement of noise and brightness at the time of placing the devices, application of the visual sleep scale in the morning during the physical examination, note every two hours on a specific form whether the patient remains with the devices. These steps will be performed by the interventionist nurses who will be trained by the main researcher and will approach the patients in the inpatient unit or in the Intensive Care Unit after admission. The intervention will be applied only in the Cardiac Intensive Care Unit, and after discharge from the ICU, patients will be able to use it if they want the devices to sleep.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Hygiene
    Keywords
    Sleep Deprivation, Intensive Care Units

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The sample will be divided into two groups: intervention group (formed by participants who will wear eye masks and hearing protectors) and control group (formed by participants who will not use any device, that is, they will receive the usual care of the unit that does not include any sleep hygiene approach)
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The main researcher will not participate in the recruitment, application of the intervention and data collection steps. There will be interventional nurses who have been trained by them and who will do these actions.The outcomes defined at the beginning of the study will be analyzed by a statistician who will not participate in the randomization process and in any step prior to data analysis
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Participants will not use the devices at any time of admission to the intensive care unit
    Intervention Type
    Device
    Intervention Name(s)
    Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.
    Intervention Description
    When they meet the inclusion criteria and accept to participate in the study, the interventionist nurse will explain to the patient the objectives and protocol of the study, apply the consent form and the instruments for assessing sleep (pittsburgh), trait and state anxiety (STAI). Then the software will be randomized and after defining the group, the nurse will guide the patient on the use of the devices from 9:00 am until the final awakening in the morning. Control group participants will only complete the assessment instruments. Noise and brightness will be measured at randomization of participants. The following morning, the visual sleep scale and the sleepiness scale will be applied for both groups, in addition to filling in information regarding the length of time the devices stay with patients at night and the clinical data that will be collected until discharge from the hospital. ICU, when independent of the group, the state anxiety instrument will be applied.
    Primary Outcome Measure Information:
    Title
    Sleep quality
    Description
    Sleep quality will be assessed by the visual sleep scale, adapted and validated in Brazil from the original instrument Verran Snyder-Halpern Sleep Scale that allows daily self-assessment of the sleep efficiency of hospitalized patients regarding their last night of slep
    Time Frame
    During the patient's stay in the ICU until discharge from the unit during the patient's stay in the ICU until discharge from the unit for about three months
    Secondary Outcome Measure Information:
    Title
    Sleepiness
    Description
    The Epworth Excessive Sleepiness Scale (ESS) will be used in the morning to allow the patient to self-assess the outcome
    Time Frame
    During the patient's stay in the ICU until discharge from the unit during the patient's stay in the ICU until discharge from the unit for about three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age over 18 years. Have the ability to communicate verbally and understand what is requested in the assessment instruments, according to the nurse's initial assessment performed on admission. Exclusion Criteria: Report of a serious sleep disorder that requires daily treatment before hospitalization, such as sleep apnea, narcolepsy and chronic insomnia. Presence of severe complication (aortic dissection, bleeding or stroke after the procedure) related to the treatment. Presence of delirium as assessed in the medical record. Severe hearing and visual loss. History of neurological disease or diagnosed psychiatric disorders. Admission to the Intensive Care Unit between the hours of 9:00 pm to 6:00 am after the percutaneous intervention procedure. Treatment with mechanical ventilation. Need for sedation while in the ICU. Who are not fluent in the Portuguese language.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Regina Souza, Master
    Phone
    +5511972746161
    Email
    regina.souza@hsl.org.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Regina Souza, master
    Organizational Affiliation
    Hospital Sirio-Libanes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26785964
    Citation
    Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056.
    Results Reference
    background
    Citation
    Cicek HS, Armutcu B, Dizer B,Yava A, Tosun N, Celik T. Sleep quality of patients hospitalized in the coronary intensive care unit and the affecting factors. International Journal of Caring Sciences. 2014;7(1):324-32.
    Results Reference
    background
    PubMed Identifier
    28902932
    Citation
    Machado FS, Souza RCDS, Poveda VB, Costa ALS. Non-pharmacological interventions to promote the sleep of patients after cardiac surgery: a systematic review. Rev Lat Am Enfermagem. 2017 Sep 12;25:e2926. doi: 10.1590/1518-8345.1917.2926.
    Results Reference
    background
    Citation
    Vieira JV, Ferreira RF, Goes MP. Ear and eye protectors in the promotion of sleep in intensive care. J Nurs UFPE 2018;12(10):2784-93. https://doi.org/10.5205/1981-8963-v12i10a236958p2784-2793-2018.
    Results Reference
    background
    PubMed Identifier
    27390455
    Citation
    Dhooria S, Sehgal IS, Agrawal AK, Agarwal R, Aggarwal AN, Behera D. Sleep after critical illness: Study of survivors of acute respiratory distress syndrome and systematic review of literature. Indian J Crit Care Med. 2016 Jun;20(6):323-31. doi: 10.4103/0972-5229.183908.
    Results Reference
    background
    PubMed Identifier
    21185560
    Citation
    Elliott R, McKinley S, Cistulli P. The quality and duration of sleep in the intensive care setting: an integrative review. Int J Nurs Stud. 2011 Mar;48(3):384-400. doi: 10.1016/j.ijnurstu.2010.11.006. Epub 2010 Dec 24.
    Results Reference
    background
    PubMed Identifier
    28726359
    Citation
    Menger J, Urbanek B, Skhirtladze-Dworschak K, Wolf V, Fischer A, Rinosl H, Dworschak M. Earplugs during the first night after cardiothoracic surgery may improve a fast-track protocol. Minerva Anestesiol. 2018 Jan;84(1):49-57. doi: 10.23736/S0375-9393.17.11758-X. Epub 2017 Jul 20.
    Results Reference
    background
    PubMed Identifier
    28944590
    Citation
    Locihova H, Axmann K, Padysakova H, Fejfar J. Effect of the use of earplugs and eye mask on the quality of sleep in intensive care patients: a systematic review. J Sleep Res. 2018 Jun;27(3):e12607. doi: 10.1111/jsr.12607. Epub 2017 Sep 25.
    Results Reference
    background
    PubMed Identifier
    25704734
    Citation
    Sadeh A. Iii. Sleep assessment methods. Monogr Soc Res Child Dev. 2015 Mar;80(1):33-48. doi: 10.1111/mono.12143.
    Results Reference
    background

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    Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases

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