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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Meryem PELİN

    Sakarya, Serdivan, 54050

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04934436
Study groupRoleWhat they receive
Intervention GroupExperimentalAccording 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 GroupNo interventionAll 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted22 Jun 2021
  2. Study start9 Sep 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Resources

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)
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

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.

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