Circadian RhythmNCT04934436
The Effect of Nursing Care on Circadian Rhythm
A study testing sleeping glasses and earplug in people with Circadian Rhythm and Chronobiology Disorders, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to determine the effect of nursing care provided to intensive unit care patients according to their circadian rhythms on sleep quality, pain, anxiety and delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Rhythm, Chronobiology Disorders, Biological Clock Disturbance
- What is being tested?
- sleeping glasses and earplug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2022to 1 Feb 2023
- 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
- Being over 18 years old
- Being literate
- Not having communication difficulties (Sensory losses such as vision and hearing)
- Volunteering to participate in the research.
- Not having a psychiatric diagnosis by a specialist physician
- Being open to communication and cooperation
- Being admitted to the coronary intensive care unit due to Acute Coronary Syndrome and Myocardial Infarction
Who cannot join
- Having a diagnosed delirium
- Receiving ventilator support
- Using sleeping pills
- Having a diagnosis of dementia
- Insomnia/propensity to sleep as a side effect of the medication used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nursing Care Provided to Coronary Intensive Care Patients According to Their Circadian Rhythms on Sleep Quality, Pain, Anxiety and Delirium
The aim of this project is to determine the effect of nursing care provided to intensive unit care patients according to their circadian rhythms on sleep quality, pain, anxiety and delirium.
Read the detailed description
During the current national and international literature review, the studies were seen to mostly focus on subjects such as circadian rhythm and psychological disorders and problems, obesity, cancer, etc. No studies were found on the effect of nursing care provided according to circadian rhythm. Therefore, it is thought that determining chronotypes and providing appropriate nursing care is important to prevent pain, sleep, delirium and many physiological parameters and comorbid diseases, especially in intensive care patients, in terms of maintaining the circadian rhythm.
The study population will consist of patients treated in the Coronary Intensive Care Unit of Sakarya University Training and Research Hospital. A total of 32 patients will form the sample of the study, including 16 in intervention and 16 in a control group that agree to participate in the study and meet the study criteria. In terms of the reliability of the study results, the patients in this study will be allocated to the groups with a stratified randomization method. Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms. Data will be collected after obtaining the institution's permission, the approval of the Ethics Committee, and the patients' consent through a face-to-face interview with patients. Firstly, the patients will be evaluated after admitted to the intensive care unit, and the intervention and control group will be formed using a stratified randomized method from those meeting the study criteria. All surveys that will be used in the study will be applied to both groups during the first interview. According to their chronotype, the intervention group will then be given sleeping glasses and earplugs at night for those who are in the morningtype, and till afternoon during the day for those who are in the eveningtype. Moreover, patients in the intervention group will be given 5000 Lux daylight(Maldonado, 2017) during the time they are awake depending on their circadian rhythms. An Android smartwatch will be used to determine patients' sleeping and waking up times, sleep quality and sleep depth. Nursing care will also be provided when patients are awake per their chronotype. Before the study, intensive care nurses will be trained to provide appropriate care according to the circadian rhythm and chronotype to have consistency in the care. Patients will be observed for three days and during this time cortisone and melatonin levels will be checked in both control and intervention groups (this test is not provided regularly but it will be paid by the financial sponsors). At the end of the third day, surveys will be conducted once again with both groups. All through this time, the control group will not have any interventions, only the standard ICU care to be provided.
In the study, "Patient Information Form, The Richards-Campbell Sleep Questionnaire, the Sleep Quality Scale which is planned to be developed, Intensive Care Delirium Screening Checklist, Horne and Ostberg Morningness-Eveningness Questionnaire, Daily Rhythm Questionnaire, Hospital Anxiety and Depression Scale" will be used as a part of the pre-test. Three days later, "Patient Information Form, The Richards-Campbell Sleep Questionnaire, the Sleep Quality Scale which is planned to be developed, Intensive Care Delirium Screening Checklist, Horne and Ostberg Morningness-Eveningness Questionnaire, Daily Rhythm Questionnaire, Hospital Anxiety and Depression Scale" will be applied to the patients as a part of the post-test.
As part of this study, a new scale specific to intensive care patients will be developed. The effects of nursing care given in accordance with the circadian rhythm, which has not been investigated before, on sleep quality, pain, delirium, and anxiety will be revealed.
- Conditions
- Circadian Rhythm, Chronobiology Disorders, Biological Clock Disturbance, Nursing Care, Sleep Quality
- Being tested
- sleeping glasses and earplug
- Medical subject headings
- Chronobiology Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeping glasses and earplugOther
Also called nursing care
In this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | According to their chronotype, the intervention group will then be given sleeping glasses and earplugs at night for those who are in the morning type, and till afternoon during the day for those who are in the evening type. Moreover, patients in the intervention group will be given 5000 Lux daylight during the time they are awake depending on their circadian rhythms. An Android smartwatch will be used to determine patients' sleeping and waking up times, sleep quality and sleep depth. Nursing care will also be provided when patients are awake per their chronotype. Before the study, intensive care nurses will be trained to provide appropriate care according to the circadian rhythm and chronotype to have consistency in the care. Patients will be observed for three days and during this time cortisone and melatonin levels will be checked in both control and intervention groups. At the end of the third day, surveys will be conducted once again with both groups. Receives: Other: sleeping glasses and earplug |
| Control Group | No intervention | All surveys that will be used in the study will be applied to both groups during the first and last interviews. The control group will not have any interventions, only the standard ICU care to be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the sleep quality
The effect of nursing care given in accordance with the chronotypes of individuals on sleep quality is the primary result for this study. This output measured by SQ-CC scale developed by authors.
Measured: At the end of the 3rd day
Change in the pain levels
It was measured using VAS whether there was a decrease in the patients' pain scores as a result of the intervention after 3 days.
Measured: At the end of the 3rd day
Change in the Anxiety levels
HADS was used to measure whether there was a decrease in the patients' anxiety levels as a result of the intervention after 3 days.
Measured: At the end of the 3rd day
Change in the delirium score
After 3 days, it was measured using ICDSC whether the patients' rates of going into delirium decreased or whether their scores decreased as a result of the intervention.
Measured: At the end of the 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start9 Sep 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circadian RhythmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In terms of the reliability of the study results, the patients in this study will be allocated to the groups with a stratified randomization method. Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva SERT, Sakarya University
- Investigators
- Meryem PELİN, Principal investigator, Sakarya University Health Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934436
- Sponsor's protocol ID
- SAU
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pelin M, Sert H. The effect of nursing care provided to coronary intensive care patients according to their circadian rhythms on sleep quality, pain, anxiety, and delirium: a randomised controlled trial. BMC Nurs. 2025 Feb 7;24(1):143. doi: 10.1186/s12912-025-02793-8.
PubMed 39920733
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Provided to Coronary Intensive Care Patients According to Their Circadian Rhythms on Sleep Quality, Pain, Anxiety and Delirium
- ClinicalTrials.gov ID
- NCT04934436
- Acronym / sponsor ID
- SAU
- Conditions
- Circadian Rhythm, Chronobiology Disorders, Biological Clock Disturbance, Nursing Care, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Jun 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.
The aim of this project is to determine the effect of nursing care provided to intensive unit care patients according to their circadian rhythms on sleep quality, pain, anxiety and delirium.
Detailed description
During the current national and international literature review, the studies were seen to mostly focus on subjects such as circadian rhythm and psychological disorders and problems, obesity, cancer, etc. No studies were found on the effect of nursing care provided according to circadian rhythm. Therefore, it is thought that determining chronotypes and providing appropriate nursing care is important to prevent pain, sleep, delirium and many physiological parameters and comorbid diseases, especially in intensive care patients, in terms of maintaining the circadian rhythm.
The study population will consist of patients treated in the Coronary Intensive Care Unit of Sakarya University Training and Research Hospital. A total of 32 patients will form the sample of the study, including 16 in intervention and 16 in a control group that agree to participate in the study and meet the study criteria. In terms of the reliability of the study results, the patients in this study will be allocated to the groups with a stratified randomization method. Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms. Data will be collected after obtaining the institution's permission, the approval of the Ethics Committee, and the patients' consent through a face-to-face interview with patients. Firstly, the patients will be evaluated after admitted to the intensive care unit, and the intervention and control group will be formed using a stratified randomized method from those meeting the study criteria. All surveys that will be used in the study will be applied to both groups during the first interview. According to their chronotype, the intervention group will then be given sleeping glasses and earplugs at night for those who are in the morningtype, and till afternoon during the day for those who are in the eveningtype. Moreover, patients in the intervention group will be given 5000 Lux daylight(Maldonado, 2017) during the time they are awake depending on their circadian rhythms. An Android smartwatch will be used to determine patients' sleeping and waking up times, sleep quality and sleep depth. Nursing care will also be provided when patients are awake per their chronotype. Before the study, intensive care nurses will be trained to provide appropriate care according to the circadian rhythm and chronotype to have consistency in the care. Patients will be observed for three days and during this time cortisone and melatonin levels will be checked in both control and intervention groups (this test is not provided regularly but it will be paid by the financial sponsors). At the end of the third day, surveys will be conducted once again with both groups. All through this time, the control group will not have any interventions, only the standard ICU care to be provided.
In the study, "Patient Information Form, The Richards-Campbell Sleep Questionnaire, the Sleep Quality Scale which is planned to be developed, Intensive Care Delirium Screening Checklist, Horne and Ostberg Morningness-Eveningness Questionnaire, Daily Rhythm Questionnaire, Hospital Anxiety and Depression Scale" will be used as a part of the pre-test. Three days later, "Patient Information Form, The Richards-Campbell Sleep Questionnaire, the Sleep Quality Scale which is planned to be developed, Intensive Care Delirium Screening Checklist, Horne and Ostberg Morningness-Eveningness Questionnaire, Daily Rhythm Questionnaire, Hospital Anxiety and Depression Scale" will be applied to the patients as a part of the post-test.
As part of this study, a new scale specific to intensive care patients will be developed. The effects of nursing care given in accordance with the circadian rhythm, which has not been investigated before, on sleep quality, pain, delirium, and anxiety will be revealed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In terms of the reliability of the study results, the patients in this study will be allocated to the groups with a stratified randomization method. Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: sleeping glasses and earplugAccording to their chronotype, the intervention group will then be given sleeping glasses and earplugs at night for those who are in the morning type, and till afternoon during the day for those who are in the evening type. Moreover, patients in the intervention group will be given 5000 Lux daylight during the time they are awake depending on their circadian rhythms. An Android smartwatch will be used to determine patients' sleeping and waking up times, sleep quality and sleep depth. Nursing care will also be provided when patients are awake per their chronotype. Before the study, intensive care nurses will be trained to provide appropriate care according to the circadian rhythm and chronotype to have consistency in the care. Patients will be observed for three days and during this time cortisone and melatonin levels will be checked in both control and intervention groups. At the end of the third day, surveys will be conducted once again with both groups. |
| Control Group | No intervention | –All surveys that will be used in the study will be applied to both groups during the first and last interviews. The control group will not have any interventions, only the standard ICU care to be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being over 18 years old
- Being literate
- Not having communication difficulties (Sensory losses such as vision and hearing)
- Volunteering to participate in the research.
- Not having a psychiatric diagnosis by a specialist physician
Key exclusion criteria (5 listed)
- Having a diagnosed delirium
- Receiving ventilator support
- Using sleeping pills
- Having a diagnosis of dementia
- Insomnia/propensity to sleep as a side effect of the medication used.
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 |
|---|---|---|
| sleeping glasses and earplugAlso: nursing careIn this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined. | Other | Intervention Group |
Primary outcome
Change in the sleep quality
Time frame: At the end of the 3rd day
The effect of nursing care given in accordance with the chronotypes of individuals on sleep quality is the primary result for this study. This output measured by SQ-CC scale developed by authors.
Change in the pain levels
Time frame: At the end of the 3rd day
It was measured using VAS whether there was a decrease in the patients' pain scores as a result of the intervention after 3 days.
Change in the Anxiety levels
Time frame: At the end of the 3rd day
HADS was used to measure whether there was a decrease in the patients' anxiety levels as a result of the intervention after 3 days.
Change in the delirium score
Time frame: At the end of the 3rd day
After 3 days, it was measured using ICDSC whether the patients' rates of going into delirium decreased or whether their scores decreased as a result of the intervention.
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 20 Mar 2024.
- Derived from this study: PubMed 39920733Pelin M, Sert H. The effect of nursing care provided to coronary intensive care patients according to their circadian rhythms on sleep quality, pain, anxiety, and delirium: a randomised controlled trial. BMC Nurs. 2025 Feb 7;24(1):143. doi: 10.1186/s12912-025-02793-8.
- 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.
Meryem PELİN principal investigator
Sakarya University Health Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeping glasses and earplug in people with Circadian Rhythm and Chronobiology Disorders, 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?
The sponsor lists 7 inclusion and 5 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 20 Mar 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?
Change in the sleep quality (time frame: At the end of the 3rd day). The study lists 4 primary outcomes in all. 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 NCT04934436, which also lists 1 linked publication.
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 Mar 2024.