The Effect of Nursing Care on Circadian Rhythm

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality; Circadian Rhythm; Chronobiology Disorders; Nursing Care; Biological Clock Disturbance
• Intervention / Treatment: Other: sleeping glasses and earplug

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Serdivan
    • Sakarya, Serdivan, Turkey, 54050
      • Meryem PELİN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: sleeping glasses and earplug; In this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined.; Other Names: nursing care
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At the end of the 3rd day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of nursing care on pain	The effect of nursing care given in accordance with the chronotypes of individuals on pain. This output will be measured 0-10 Numeric Pain Rating Scale.	the difference between Numeric Pain Rating Scale points on the first day and the third day
The effect of nursing care on anxiety	The effect of nursing care given in accordance with the chronotypes of individuals on anxiety. This output will be measured by the Hospital Anxiety and Depression Scale.	the difference between Hospital Anxiety and Depression Scale points on the first day and the third day
The effect of nursing care on delirium	The effect of nursing care given in accordance with the chronotypes of individuals on delirium. This output will be measured by the Intensive Care Delirium Screening Checklist.	the difference between the Intensive Care Delirium Screening Checklist points on the first day and the third day

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Principal Investigator: Meryem PELİN, Sakarya University Health Science Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders
• Other Study ID Numbers: SAU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No