Coronary Artery DiseasesNCT05486780
The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients
A study testing Digital Window in people with Coronary Artery Diseases and Heart Valve Diseases, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Coronary Artery Diseases, Heart Valve Diseases
- What is being tested?
- Digital Window
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital-Cardiovascular Surgery Intensive Care Unit
Ankara, Altındag, 06230
Nigar Unlusoy Dincer, RN, PhD, Assistant Proffessor, +90 533 653 19 39, nigardincer@yahoo.com
About this study
Official title: The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Coronary Artery Diseases, Heart Valve Diseases
- Being tested
- Digital Window
- Keywords
- intensive care units, daylight, postoperative patient, sleep quality, clinical trial
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital WindowBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measurements at the post-op 1., 2. and 3. days after the completion of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start8 Aug 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseasesStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ikbal bezek, Ankara Yildirim Beyazıt University
- Investigators
- İlkbal Bezek, Master Student, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486780
- Sponsor's protocol ID
- ilkbal-dw
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The confidentiality of the data used in the study will be protected.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05486780
- Acronym / sponsor ID
- ilkbal-dw
- Conditions
- Coronary Artery Diseases, Heart Valve Diseases
- Keywords
- intensive care units, daylight, postoperative patient, sleep quality, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital window | Experimental | Behavioral: Digital WindowThe 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. |
| 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. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital WindowFor 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. | Behavioural | Digital window |
Primary outcome
1.Change in sleep quality
Time frame: Baseline measurements (Pre-op), at the post-op 1., 2. and 3. days after the completion of the interventions
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
Time frame: Measurements at the post-op 1., 2. and 3. days after the completion of the interventions
Day and night perception status will be measured based on the patient report byDay and Night Perception Form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No. The confidentiality of the data used in the study will be protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlkbal Bezek, Master Student principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Window in people with Coronary Artery Diseases and Heart Valve Diseases, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İlkbal Bezek, Master Student (+90 537 477 49 27, ilkbalbezek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Change in sleep quality (time frame: Baseline measurements (Pre-op), at the post-op 1., 2. and 3. days after the completion of the interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.