Sleep Quality of ICU PatientsNCT03856489
Patients' Sleep at the Intensive Care Unit
An observational study of Sleep Quality of ICU Patients, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality of ICU Patients
- What is being tested?
- Richards-Campbell Sleeping Questionnaire (RCSQ)
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2019to 31 Oct 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients hospitalized at intensive care units at the University Hospital Ostrava, Czech Republic fulfiling the inclusion criteria.
Who may be able to join
- ICU patients
- Age 18 years and older
- Glasgow coma scale 15
Who cannot join
- Age < 18 years
- Glasgow coma scale < 15
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients.
Read the detailed description
The main instrument of this research is the Richards Campbell Sleeping Questionnaire (RCSQ) regarding patients' overnight sleep quality. This questionnaire is given to complete to eligible patients between 7 am and 10 am. The same questionnaire is given to the night-shift nurse between 7 am and 7:30 am, who was taking care of that particular patient overnight. This RCQS assessment is based solely on each nurse´s perception of the patient´s sleep quality last night. Neither the nurse nor the patient know each other´s RCSQ response.
- Conditions
- Sleep Quality of ICU Patients
- Being tested
- Richards-Campbell Sleeping Questionnaire (RCSQ)
- Keywords
- sleep, intensive care unit, patient, nurse, inter-rater reliability, Richards-Campbell sleeping questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Richards-Campbell Sleeping Questionnaire (RCSQ)Other
This five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Patients | This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 10 am. Receives: Other: Richards-Campbell Sleeping Questionnaire (RCSQ) | |
| Nurses | This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 7:30 am. Receives: Other: Richards-Campbell Sleeping Questionnaire (RCSQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-nurse inter-rater reliability
The inter-rater reliability between the evaluation of sleep quality performed by the patient and the nurse, as per Richards-Campbell Sleeping Questionnaire (RCSQ) score achieved, will be assessed. The RCSQ tool is used to assess a total of five dimensions pertaining to sleep, each of which is evaluated on a scale of 0 to 100.
Measured: 30 weeks
Secondary outcomes (1)
Patient sleep quality
The quality of patient sleep will be evaluated using the achieved Richards-Campbell Sleeping Questionnaire (RCSQ) scores. The RCSQ tool is used to assess a total of five dimensions pertaining to sleep, each of which is evaluated on a scale of 0 to 100.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Quality of ICU PatientsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kateřina Tejkalová, Mgr., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856489
- Sponsor's protocol ID
- FNO-KARIM-10-SLEEP
- Status last verified
- Jun 2021
- First submitted
- 26 Feb 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not decided to make individual participant data available to other researchers.
Publications
Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
PubMed 22751369Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.
PubMed 14637294
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Sleep at the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03856489
- Acronym / sponsor ID
- FNO-KARIM-10-SLEEP
- Conditions
- Sleep Quality of ICU Patients
- Keywords
- sleep, intensive care unit, patient, nurse, inter-rater reliability, Richards-Campbell sleeping questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 27 Feb 2019 (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.
The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients.
Detailed description
The main instrument of this research is the Richards Campbell Sleeping Questionnaire (RCSQ) regarding patients' overnight sleep quality. This questionnaire is given to complete to eligible patients between 7 am and 10 am. The same questionnaire is given to the night-shift nurse between 7 am and 7:30 am, who was taking care of that particular patient overnight. This RCQS assessment is based solely on each nurse´s perception of the patient´s sleep quality last night. Neither the nurse nor the patient know each other´s RCSQ response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Richards-Campbell Sleeping Questionnaire (RCSQ)This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 10 am. |
| Nurses | – | Other: Richards-Campbell Sleeping Questionnaire (RCSQ)This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 7:30 am. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at intensive care units at the University Hospital Ostrava, Czech Republic fulfiling the inclusion criteria.
Key inclusion criteria (3 listed)
- ICU patients
- Age 18 years and older
- Glasgow coma scale 15
Key exclusion criteria (2 listed)
- Age < 18 years
- Glasgow coma scale < 15
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 |
|---|---|---|
| Richards-Campbell Sleeping Questionnaire (RCSQ)This five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality. | Other | Nurses, Patients |
Primary outcome
Patient-nurse inter-rater reliability
Time frame: 30 weeks
The inter-rater reliability between the evaluation of sleep quality performed by the patient and the nurse, as per Richards-Campbell Sleeping Questionnaire (RCSQ) score achieved, will be assessed. The RCSQ tool is used to assess a total of five dimensions pertaining to sleep, each of which is evaluated on a scale of 0 to 100.
1 secondary outcome
Patient sleep quality
Time frame: 30 weeks
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 2 Jun 2021.
- Background: PubMed 22751369Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
- Background: PubMed 14637294Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.
- Individual participant dataSharing planned: Undecided. The investigators have not decided to make individual participant data available to other researchers.
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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.
Kateřina Tejkalová, Mgr. principal investigator
University Hospital Ostrava
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 Sleep Quality of ICU Patients, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2021. 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 Czechia. 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?
Patient-nurse inter-rater reliability (time frame: 30 weeks). 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 NCT03856489, which also lists 2 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 2 Jun 2021.