The Effect of Nursing Care on Circadian Rhythm

NCT04934436 | Completed

• 1 other identifier: SAU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm; Chronobiology Disorders; Biological Clock Disturbance; Nursing Care; Sleep Quality

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Interventions

sleeping glasses and earplug OTHER

In this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined.

Also known as: nursing care

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients will be randomly matched to the intervention (I) and control (C) group according to their gender, age, and circadian rhythms
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Meryem PELİN

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39920733 DERIVED

MeSH Terms

Conditions

Chronobiology Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices; Nursing Care

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Meryem PELİN

  Sakarya University Health Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 22, 2021
• Study Start: September 9, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)