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

Heart Valve Diseases Clinical Trial

Official title:

The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486780
• Other study ID #: ilkbal-dw
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: August 2022
• Source: Ankara Yildirim Beyazit University
• Contact: Ilkbal Bezek, Master Student
• Phone: +90 537 477 49 27
• Email: ilkbalbezek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This research will be carried out as a randomized controlled experimental study to investigate the effect of the digital window on day and night perception status and sleep quality in intensive care patients. The research population consists of patients who underwent CABG and heart valve surgery and were admitted to the CVC ICU of Ankara Training and Research Hospital.

Sample size calculation

In order to calculate the sample size, a pilot study was conducted with 6 patients, three in the experimental group and three in the control group, and these pilot study data were used. As a result of the power analysis made with the help of the G*Power 3.0.10 program, the power of the study was found to be 80% for 2 groups and 3 repetitive study designs with an f=0.20 effect size and 5% margin of error. As a result, at least 42 samples in total, 21 of which were in the experimental group and 21 in the control group, were found to be sufficient. Considering that the sample size obtained is the lowest limit and the patients have the possibility of going into delirium under intensive care conditions or giving up on continuing to work afterward, considering that the losses may be high, 15% of the number determined according to the sampling calculation was calculated and 48 patients who met the criteria for inclusion in the study were sampled. In experimental studies, it is recommended that the sample loss should not be more than 10-15%.

Randomization

A 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. Whether the first female and first male patients who will come at the beginning of the study will be in the experimental group or the control group will be determined by drawing lots. The following patients will be divided into two groups, according to the order of arrival, the same-sex patients in the experimental group and the control group.

Data collection tools: The data in the research; Patient Information Form, Richard-Campbell Sleep Questionnaire_RCSQ will be collected using the Day and Night Perception Form.

Research Implementation

Whether the first female and first male patients to come to the CVS ICU on the day of surgery will be the experimental group or the control group will be determined by drawing lots. The following patients will be divided into two groups, according to the order of arrival, same-sex patients in the experimental group and the control group. In this way, it is planned to establish a balance between the groups according to gender. The patients who will be assigned to the experimental group will sleep on the 1st, 2nd, and 3rd beds, and the patients who will be assigned to the control group will sleep in the 4th, 5th, and 6th beds. 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 experimental group who are in the field of view of the digital window and the patients in the control group who are not in the field of view of the digital window. Night and Day Perception Form will be administered twice a day, once in the morning and in the evening, and Richards Campbell Sleep Scale will be administered once in the morning to each patient at the same time interval.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: January 10, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Heart Valve Diseases

Intervention

Behavioral:
• Digital Window
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.

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital-Cardiovascular Surgery Intensive Care Unit	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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