Delirium and Insomniadelirium sleepNCT06699004
Diagnosis of Delirium and Assessment of Sleep Quality in Patients in the Anesthesia and Intensive Care Unit
An observational study of Delirium and Insomnia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study included patients in the anesthesia and intensive care unit (ICU). Over half the patients did not experience delirium. The correct structuring of the physical conditions in the ICU and the professional approaches of the nurses contributed to this outcome. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium and Insomnia
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2022to 21 Jan 2023
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HOSPİTAL
Inclusion Criteria:• Patients aged 18 years and older, who were hospitalized in the anesthesia and reanimation intensive care unit of Sakarya Education and Research Hospital between October 2022 and January 2023
- Patients without communication problems (hearing, speech, comprehension, etc.)
- Patients who have been hospitalized in the intensive care unit for at least 24 hours
- Patients not in a coma (RASS: between -3 and +4, GCS: 10 or above)
- Patients without a diagnosed dementia
- Patients without mental status disorders or psychological illnesses
- Patients who are willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Internal Medicine Nursing, Faculty of Health Sciences, Sakarya University, 54050, Serdivan / SAKARYA.
Serdivan, Sakarya, 54050
About this study
This study included patients in the anesthesia and intensive care unit (ICU). Over half the patients did not experience delirium. The correct structuring of the physical conditions in the ICU and the professional approaches of the nurses contributed to this outcome. Moreover, patients with delirium had lower sleep quality and lower Glasgow Coma Scale (GCS) scores than those without delirium.
Read the detailed description
Delirium is a condition involving functional losses in the brain due to both structural and vascular abnormalities caused dehydration and hypoperfusion, which prevent the transport of oxygen and glucose to neurons, thereby leading to metabolic dysfunction in the brain. Moreover, delirium, which is characterized by disorientation, inattention, and changes in thoughts and/or behaviors, is a serious and widespread neuropsychiatric condition that frequently goes unnoticed, although it is preventable and reversible following appropriate intervention. Numerous risk factors have been found to affect the development of delirium, including prolonged hospital stays, medication use, coping mechanisms during illness, personality traits, and treatment compliance. It is believed that intensive care patients face a higher risk of developing delirium. In this regard, invasive procedures, regular nursing care, environmental noise, continuous light exposure, pre-existing sleep disorders, pain, anxiety, fear, and loneliness represent physiological and psychological factors that can lead to sleep deprivation in intensive care patients. Indeed, places such as intensive care units (ICUs), where patients are exposed to constant stimuli and may experience severe pain, can trigger stress responses that lead to agitation, sleep disorders, and delirium.
Previous studies have indicated that medications used to control delirium can negatively affect sleep quality, while worsening sleep quality can exacerbate delirium. The main goal in preventing delirium is to ensure a regular sleep-wake cycle, support adequate fluid and nutrient intake, and provide both preventive and therapeutic treatments through a systematic, multidisciplinary team-based approach to reduce the frequency and duration of delirium. Artificial intelligence and machine learning approaches enable machines to simulate complex processes such as thinking and consciousness, thereby allowing computers to learn the relationships between inputs and outputs from large datasets, which helps them to make optimal decisions, analyses, and predictions. In the healthcare field, such technology is used in many areas, including the early detection and prediction of disease, disease classification, treatment, prevention of adverse outcomes, rapid analysis of clinical data, cost-saving initiatives, provision of effective and quality care, minimization of human errors, and clinical decision-making .
In the present study, the relationship between delirium and sleep quality in patients in the anesthesia and ICU was examined and a predictive analysis using a machine learning approach was performed.
The data required for this study were collected using the Patient Information Form, Nursing Delirium Screening Scale (Nu-DESC), Richards-Campbell Sleep Scale (RCSS), Richmond Agitation-Sedation Scale (RASS), and GCS. The collected data were analyzed using the SPSS statistical program (SPSS-26), and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were followed when reporting the results. The sample size was determined using the known population sample calculation method. Both frequency and percentage analyses were used to describe the distribution of the participants' demographic characteristics, while the mean and standard deviation were used to determine the participants' levels on the utilized scales. Cronbach's alpha reliability analysis was conducted to assess the scale reliability, and the post hoc power analysis showed that the study had medium power at a 95% confidence level with 99% significance . The skewness-kurtosis values were checked to assess the normality of the distribution. An independent samples t-test was used to assess the differences between groups. For comparisons among more than two groups, a one-way analysis of variance (ANOVA) was applied, while the prediction and receiver operating characteristic (ROC) curve analyses were conducted using R version 4.1.3.
- Conditions
- Delirium and Insomnia
- Keywords
- delirium, İNSOMNİA
- Medical subject headings
- Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| İn our study there is only one group, and no intervention was made. | İn our study there is only one group, and no intervention was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Delirium and Evaluation of Sleep Quality İn Patients Hospitalized İn The Anesthesia and Reanimation İntensive Care Unit
Nursing Delirium Screening Scale:The scale consists of five items. Each item is scored between 0 and 2, with a total score ranging from 0 to 10. A score of two or more indicates delirium. According to the scale results, delirium was observed in 36.4% of the patients.
Measured: between October 2022 and January 2023
Secondary outcomes (1)
Diagnosis of Delirium and Evaluation of Sleep Quality in Patients Hospitalized in The Anesthesia and Reanimation İntensive Care Unit
Richards-Campbell Sleep Scale : Scores between 0 and 25 indicate very poor sleep, while scores between 76 and 100 indicate very good sleep. According to the scale, the average delirium score of the patients was found to be 39.30.
Measured: between October 2022 and January 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start21 Oct 2022
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium and InsomniaStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK KAYA, Sakarya University
- Investigators
- dilek kaya, Msc. student, Principal investigator, sakarya university health sciences institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699004
- Sponsor's protocol ID
- E71522473050
- Acronym
- delirium sleep
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The privacy of participants and the protection of personal information are important.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Delirium and Assessment of Sleep Quality in Patients in the Anesthesia and Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06699004
- Acronym / sponsor ID
- delirium sleep / E71522473050
- Conditions
- Delirium and Insomnia
- Keywords
- delirium, İNSOMNİA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 21 Nov 2024 (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.
This study included patients in the anesthesia and intensive care unit (ICU). Over half the patients did not experience delirium. The correct structuring of the physical conditions in the ICU and the professional approaches of the nurses contributed to this outcome. Moreover, patients with delirium had lower sleep quality and lower Glasgow Coma Scale (GCS) scores than those without delirium.
Detailed description
Delirium is a condition involving functional losses in the brain due to both structural and vascular abnormalities caused dehydration and hypoperfusion, which prevent the transport of oxygen and glucose to neurons, thereby leading to metabolic dysfunction in the brain. Moreover, delirium, which is characterized by disorientation, inattention, and changes in thoughts and/or behaviors, is a serious and widespread neuropsychiatric condition that frequently goes unnoticed, although it is preventable and reversible following appropriate intervention. Numerous risk factors have been found to affect the development of delirium, including prolonged hospital stays, medication use, coping mechanisms during illness, personality traits, and treatment compliance. It is believed that intensive care patients face a higher risk of developing delirium. In this regard, invasive procedures, regular nursing care, environmental noise, continuous light exposure, pre-existing sleep disorders, pain, anxiety, fear, and loneliness represent physiological and psychological factors that can lead to sleep deprivation in intensive care patients. Indeed, places such as intensive care units (ICUs), where patients are exposed to constant stimuli and may experience severe pain, can trigger stress responses that lead to agitation, sleep disorders, and delirium.
Previous studies have indicated that medications used to control delirium can negatively affect sleep quality, while worsening sleep quality can exacerbate delirium. The main goal in preventing delirium is to ensure a regular sleep-wake cycle, support adequate fluid and nutrient intake, and provide both preventive and therapeutic treatments through a systematic, multidisciplinary team-based approach to reduce the frequency and duration of delirium. Artificial intelligence and machine learning approaches enable machines to simulate complex processes such as thinking and consciousness, thereby allowing computers to learn the relationships between inputs and outputs from large datasets, which helps them to make optimal decisions, analyses, and predictions. In the healthcare field, such technology is used in many areas, including the early detection and prediction of disease, disease classification, treatment, prevention of adverse outcomes, rapid analysis of clinical data, cost-saving initiatives, provision of effective and quality care, minimization of human errors, and clinical decision-making .
In the present study, the relationship between delirium and sleep quality in patients in the anesthesia and ICU was examined and a predictive analysis using a machine learning approach was performed.
The data required for this study were collected using the Patient Information Form, Nursing Delirium Screening Scale (Nu-DESC), Richards-Campbell Sleep Scale (RCSS), Richmond Agitation-Sedation Scale (RASS), and GCS. The collected data were analyzed using the SPSS statistical program (SPSS-26), and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were followed when reporting the results. The sample size was determined using the known population sample calculation method. Both frequency and percentage analyses were used to describe the distribution of the participants' demographic characteristics, while the mean and standard deviation were used to determine the participants' levels on the utilized scales. Cronbach's alpha reliability analysis was conducted to assess the scale reliability, and the post hoc power analysis showed that the study had medium power at a 95% confidence level with 99% significance . The skewness-kurtosis values were checked to assess the normality of the distribution. An independent samples t-test was used to assess the differences between groups. For comparisons among more than two groups, a one-way analysis of variance (ANOVA) was applied, while the prediction and receiver operating characteristic (ROC) curve analyses were conducted using R version 4.1.3.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| İn our study there is only one group, and no intervention was made. | – | –İn our study there is only one group, and no intervention was made. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HOSPİTAL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Delirium and Evaluation of Sleep Quality İn Patients Hospitalized İn The Anesthesia and Reanimation İntensive Care Unit
Time frame: between October 2022 and January 2023
Nursing Delirium Screening Scale:The scale consists of five items. Each item is scored between 0 and 2, with a total score ranging from 0 to 10. A score of two or more indicates delirium. According to the scale results, delirium was observed in 36.4% of the patients.
1 secondary outcome
Diagnosis of Delirium and Evaluation of Sleep Quality in Patients Hospitalized in The Anesthesia and Reanimation İntensive Care Unit
Time frame: between October 2022 and January 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. The privacy of participants and the protection of personal information are important.
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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.
dilek kaya, Msc. student principal investigator
sakarya university health sciences institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Insomnia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Delirium and Evaluation of Sleep Quality İn Patients Hospitalized İn The Anesthesia and Reanimation İntensive Care Unit (time frame: between October 2022 and January 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.