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

NCT04716491 | Unknown

• 1 other identifier: AVAP-NG 1527
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Hygiene

Keywords

Sleep Deprivation; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• Sleepiness

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

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

Interventions

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

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Related Publications (9)

• 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.

  PMID: 26785964 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28902932 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27390455 BACKGROUND

• 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.

  PMID: 21185560 BACKGROUND

• 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.

  PMID: 28726359 BACKGROUND

• 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.

  PMID: 28944590 BACKGROUND

• Sadeh A. Iii. Sleep assessment methods. Monogr Soc Res Child Dev. 2015 Mar;80(1):33-48. doi: 10.1111/mono.12143.

  PMID: 25704734 BACKGROUND

MeSH Terms

Conditions

Sleep Hygiene; Sleep Deprivation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Regina Souza, master

  Hospital Sirio-Libanes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Souza, Master

CONTACT

+5511972746161; regina.souza@hsl.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Model Details: 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)

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2021
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share