The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients

NCT05486780 | Unknown DMC

• 1 other identifier: ilkbal-dw
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be carried out in the Cardio Vascular Surgery (CVS) Intensive Care Unit (ICU) of Ankara Training and Research Hospital (TRH) . Patients will be divided into two Experimental (n=24) and control (n=24) groups. Simple randomization method will be used in the study, provided that there are equal numbers of male and female patients in the experimental and control groups, regardless of the age of the patients. Patients in the experimental group will use a digital window. The "Patient Information Form","Richard-Campbell Sleep Questionnaire\_RCSQ " and " Day and Night Perception Form" will be used in the data collection phase. Ethics committee approval was received from Ankara Yıldırım Beyazıt University Ethics Committee in order to conduct the study.

Conditions

Coronary Artery Diseases; Heart Valve Diseases

Keywords

intensive care units; daylight; postoperative patient; sleep quality; clinical trial

Outcome Measures

Primary Outcomes (2)

• 1.Change in sleep quality

  Sleep quality will be measured based on the patient report by Richard-Campbell Sleep Questionnaire. A higher score means an increase in sleep quality.

  Baseline measurements (Pre-op), at the post-op 1., 2. and 3. days after the completion of the interventions

• 2. Change in day and night perception status

  Day and night perception status will be measured based on the patient report byDay and Night Perception Form.

  Measurements at the post-op 1., 2. and 3. days after the completion of the interventions

Study Arms (2)

Digital window

EXPERIMENTAL

The patients who will be assigned to the experimental group will sleep on the 1st, 2nd, and 3rd beds. Experimental group patients are in the field of view of the digital window. A digital window is a tool designed by the researcher to enable patients to differentiate between day and night.

Behavioral: Digital Window

Control group

NO INTERVENTION

the patients who will be assigned to the control group will sleep in the 4th, 5th, and 6th beds. Control group patients are not in the field of view of the digital window. Data collection will be completed by the researcher by completing the Day and Night Perception Form and the Richards Campbell Sleep Scale (Post-Test) on the 1st, 2nd, and 3rd days of post-op for the patients in the control group who are not in the field of view of the digital window.

Interventions

Digital Window BEHAVIORAL

For the digital window, a regal brand, 43R654FC, 43-inch (109 cm) television was used. A three-dimensional frame was built to give the appearance of a window around the television. For the digital window, a regal brand, 43R654FC, 43-inch (109 cm) television was used. A three-dimensional frame was built to give the appearance of a window around the television. Data collection will be completed by the researcher completing the Day and Night Perception Form and the Richards Campbell Sleep Scale (Post-Test) on the 1st, 2nd, and 3rd days of post-op for the patients in the experimental group who are in the field of view of the digital window.

Digital window

Eligibility Criteria

• Age: 19 Years - 79 Years
• Gender Eligibility Details: Research shows that gender affects sleep quality in patients with heart valve and coronary artery disease. Therefore, we will randomize participants into the groups, which were similar in terms of gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has CABG and heart valve surgery
• The patient's willingness to participate in the study voluntarily
• Patient's ability to answer research questions
• The patient's age range is 19-79
• Being in the post-op period and staying in the ICU for at least 48 hours after the post-op period
• Determined as a Glasgow Coma Scale (GCS) score of 9 or higher

You may not qualify if:

• Patient undergoing another operation other than CABG and heart valve surgery
• The patient is intubated
• The patient's use of sedating drugs
• The patient is in delirium
• Patient's age other than 19-79
• Staying in the ICU for less than 48 hours after the post-op period
• Determined as GKS score below 9

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Training and Research Hospital-Cardiovascular Surgery Intensive Care Unit

Ankara, Altındag, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• İlkbal Bezek, Master Student

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İlkbal Bezek, Master Student

CONTACT

+90 537 477 49 27; ilkbalbezek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 8, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 10, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)