Sleep HygieneNCT04716491
Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases
A study testing Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask. in people with Sleep Hygiene, run by Hospital Sirio-Libanes.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Hygiene
- What is being tested?
- Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Treatment with mechanical ventilation.
- Need for sedation while in the ICU.
- Who are not fluent in the Portuguese language.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases: Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Sleep Hygiene
- Being tested
- Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.
- Keywords
- Sleep Deprivation, Intensive Care Units
- Medical subject headings
- Sleep Hygiene, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The Epworth Excessive Sleepiness Scale (ESS) will be used in the morning to allow the patient to self-assess the outcome
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sleep HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Claudia da Silva Souza, Hospital Sirio-Libanes
- Investigators
- Regina Souza, master, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716491
- Sponsor's protocol ID
- AVAP-NG 1527
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26785964Cicek 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.
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.
PubMed 28902932Vieira 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.
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.
PubMed 27390455Elliott 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.
PubMed 21185560Menger 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.
PubMed 28726359Locihova 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.
PubMed 28944590Sadeh A. Iii. Sleep assessment methods. Monogr Soc Res Child Dev. 2015 Mar;80(1):33-48. doi: 10.1111/mono.12143.
PubMed 25704734
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Sleep for Patients Submitted to Percutaneous Intervention to Treat Heart Diseases: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04716491
- Acronym / sponsor ID
- AVAP-NG 1527
- Conditions
- Sleep Hygiene
- Keywords
- Sleep Deprivation, Intensive Care Units
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.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. | Device | Intervention group |
Primary outcome
Sleep quality
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
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
1 secondary outcome
Sleepiness
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Background: PubMed 26785964Beltrami 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.
- BackgroundCicek 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: PubMed 28902932Machado 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.
- BackgroundVieira 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: PubMed 27390455Dhooria 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.
- Background: PubMed 21185560Elliott 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.
- Background: PubMed 28726359Menger 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.
- Background: PubMed 28944590Locihova 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.
- Background: PubMed 25704734Sadeh A. Iii. Sleep assessment methods. Monogr Soc Res Child Dev. 2015 Mar;80(1):33-48. doi: 10.1111/mono.12143.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Souza, master principal investigator
Hospital Sirio-Libanes
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask. in people with Sleep Hygiene, run by Hospital Sirio-Libanes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Souza, Master (+5511972746161, regina.souza@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716491, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.