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The Effect of Nursing Care on Circadian Rhythm

Primary Purpose

Circadian Rhythm, Chronobiology Disorders, Biological Clock Disturbance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sleeping glasses and earplug
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Circadian Rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meryem PELİN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the sleep quality scale
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 will be measured by the sleep quality scale under development.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
June 7, 2021
Last Updated
May 8, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT04934436
Brief Title
The Effect of Nursing Care on Circadian Rhythm
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm, Chronobiology Disorders, Biological Clock Disturbance, Nursing Care, Sleep Quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
sleeping glasses and earplug
Other Intervention Name(s)
nursing care
Intervention Description
In this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined.
Primary Outcome Measure Information:
Title
Change in the sleep quality scale
Description
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 will be measured by the sleep quality scale under development.
Time Frame
the first day and the third day
Secondary Outcome Measure Information:
Title
The effect of nursing care on pain
Description
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.
Time Frame
the difference between Numeric Pain Rating Scale points on the first day and the third day
Title
The effect of nursing care on anxiety
Description
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.
Time Frame
the difference between Hospital Anxiety and Depression Scale points on the first day and the third day
Title
The effect of nursing care on delirium
Description
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.
Time Frame
the difference between the Intensive Care Delirium Screening Checklist points on the first day and the third day

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem PELİN
Organizational Affiliation
Sakarya University Health Science Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meryem PELİN
City
Sakarya
State/Province
Serdivan
ZIP/Postal Code
54050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Nursing Care on Circadian Rhythm

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