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

Primary Purpose

Coronary Artery Diseases, Heart Valve Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Digital Window
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Diseases focused on measuring intensive care units, daylight, postoperative patient, sleep quality, clinical trial

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Training and Research Hospital-Cardiovascular Surgery Intensive Care Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital window

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
August 2, 2022
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05486780
Brief Title
The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients
Official Title
The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 8, 2022 (Anticipated)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

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

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Diseases, Heart Valve Diseases
Keywords
intensive care units, daylight, postoperative patient, sleep quality, clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital window
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital Window
Intervention Description
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.
Primary Outcome Measure Information:
Title
1.Change in sleep quality
Description
Sleep quality will be measured based on the patient report by Richard-Campbell Sleep Questionnaire. A higher score means an increase in sleep quality.
Time Frame
Baseline measurements (Pre-op), at the post-op 1., 2. and 3. days after the completion of the interventions
Title
2. Change in day and night perception status
Description
Day and night perception status will be measured based on the patient report byDay and Night Perception Form.
Time Frame
Measurements at the post-op 1., 2. and 3. days after the completion of the interventions

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İlkbal Bezek, Master Student
Phone
+90 537 477 49 27
Email
ilkbalbezek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlkbal Bezek, Master Student
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital-Cardiovascular Surgery Intensive Care Unit
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06230
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nigar Unlusoy Dincer, RN, PhD, Assistant Proffessor
Phone
+90 533 653 19 39
Email
nigardincer@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The confidentiality of the data used in the study will be protected.

Learn more about this trial

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

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