Coronary Artery DiseaseNCT06961539
"The Effect of Virtual Visitation in the Intensive Care Unit on Pain, Anxiety, and Sleep Levels"
A study testing The group with virtual visits in people with Coronary Artery Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Patients in the intensive care unit after cardiovascular surgery face not only complications related to the surgical procedure but also emotional distress due to separation from their loved ones. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- The group with virtual visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 Mar 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40 and above,
- Underwent elective coronary artery bypass graft surgery,
- Conscious, extubated, and hemodynamically stable,
- Glasgow Coma Scale score of 15,
- Followed in the intensive care unit for at least 48 hours after surgery,
- Patients who agreed to participate in the study.
Who cannot join
- Patients with psychiatric disorders and using medication,
- Illiterate patients,
- Patients without a relative who can conduct the virtual visit,
- Patients with communication problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hamidiye Institute of Health Sciences, University of Health Sciences
Istanbul, Uskudar
About this study
Official title: The Effect on Pain, Anxiety and Sleep Levels of Virtual Visiting in the Cardiovascular Surgery Intensive Care Unit: A Randomized Controlled Trial
Patients in the intensive care unit after cardiovascular surgery face not only complications related to the surgical procedure but also emotional distress due to separation from their loved ones.
Because of infection control measures, visitor restrictions are enforced in intensive care units, which may further contribute to patient stress.
This study aims to evaluate the effect of scheduled virtual visitation in the intensive care environment on patients' postoperative pain, anxiety, and sleep levels.
Read the detailed description
Cardiovascular diseases are a group of disorders of the heart and blood vessels, causing an estimated 17.9 million deaths globally each year, and are among the leading causes of death worldwide.Coronary artery bypass graft (CABG) surgery, considered a last-resort treatment option in terms of cardiovascular disease risk factors, is a costly intervention; however, it has shown an increasing trend in its application over the past 50 years and remains the most commonly performed cardiac surgical procedure worldwide.Postoperative complications not only negatively affect the patient's recovery process but also lead to an increase in healthcare costs (9). Common issues related to surgery and anesthesia include changes in the respiratory, circulatory, and neurological systems, as well as discomfort such as pain, nausea, and vomiting.Additionally, the isolated environment of the intensive care unit can lead to various emotional problems such as delirium, anxiety, depression, spiritual distress, pain, and sleep disturbances, alongside physiological complications.
Technology provides significant convenience in all aspects of our lives. The use of technological applications in healthcare is becoming increasingly widespread and is preferred by patients, their relatives, and healthcare professionals. Surgical procedures can lead to both physical and psychological complications in patients. The fact that the patient is in a foreign environment, such as an intensive care unit, and cannot see their loved ones at will, adds an extra source of stress for the patient.
Virtual visitation in the intensive care unit is not only an easy, cost-effective, and reliable method, but it can also have positive psychological effects for both the patient and their family. The virtual visitation application can be used as an alternative option for relatives who cannot visit the hospital due to distance, cost, illness, or other responsibilities, and as a result, cannot meet with their loved one. From the patient's perspective, being able to meet with a relative at any time during treatment in the foreign and complex environment of the intensive care unit has been shown to have positive effects in the studies in the literature. However, in the related literature review, it was observed that virtual visitation was only used during the COVID-19 (Coronavirus Disease 2019) pandemic, and there were no studies that combined virtual visits with face-to-face visits. Virtual visitation should also be an alternative visitation option for patients who undergo major surgeries, such as coronary artery bypass graft (CABG) surgery, and require postoperative follow-up in the intensive care unit. No studies have been found evaluating pain, anxiety, and sleep levels in CABG patients after virtual visits, and it is expected that this study will contribute to the literature in this regard.
- Conditions
- Coronary Artery Disease
- Being tested
- The group with virtual visits
- Keywords
- Pain, Cardiovascular surgery, Anxiety, virtual visiting, sleep
- Medical subject headings
- Coronary Artery Disease, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group with virtual visitsOther
On the first day after open-heart surgery in the intensive care unit, in addition to face-to-face visits, video calls were made through the researcher's phone in the morning and evening."
| Study group | Role | What they receive |
|---|---|---|
| The group with virtual visits | Experimental | In this group, in addition to face-to-face visits in the intensive care unit after cardiac surgery, virtual visits were conducted with the patients' relatives via WhatsApp (a type of smartphone app) through a smartphone by the applying researcher, totaling five minutes. These visits were conducted twice on the first day after surgery, at 10:00 AM (Ante Meridiem) and 10:00 PM ( Post Meridiem)." Receives: Other: The group with virtual visits |
| The group without virtual visits | No intervention | In this group, patients received a face-to-face visit once a day at 1:00 PM (Post Meridiem) on the first day after surgery, according to the clinic's routine. The scales used in the study were applied at the same time interval as in the intervention group." |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Rating Scale
The Numerical Rating Scale is a unidimensional scale used to measure pain intensity, with numerical values ranging from 0 to 10. The patient is asked to choose the number that best reflects the pain intensity, where 0 = no pain and 10 = the worst (intolerable) pain."
Measured: one day
Secondary outcomes (1)
The State-Trait Anxiety Inventory"
The inventory consists of two subscales: State Anxiety and Trait Anxiety. The State Anxiety Inventory measures how an individual expresses themselves in the current situation, while the Trait Anxiety Inventory measures how the individual expresses themselves in general, not in a specific moment. The State Anxiety Inventory consists of a total of 20 items. Each item in the inventory uses a four-point Likert scale: "(1) not at all," "(2) a little," "(3) quite a bit," and "(4) completely," with reverse scoring applied to items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score obtained from the inventory ranges from 20 to 80. A higher score on the inventory indicates a higher level of anxiety in the individual.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Oct 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Model description
- Intervention group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Karatay, Saglik Bilimleri Universitesi
- Investigators
- Gülay Karatay, Principal investigator, Saglik Bilimleri UniversitesiElif Gezginci Akpınar, Assoc. Prof., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961539
- Sponsor's protocol ID
- SBU-SBF-GK-01
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Pain, Anxiety and Sleep Levels of Virtual Visiting in the Cardiovascular Surgery Intensive Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06961539
- Acronym / sponsor ID
- SBU-SBF-GK-01
- Conditions
- Coronary Artery Disease
- Keywords
- Pain, Cardiovascular surgery, Anxiety, virtual visiting, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 8 May 2025 (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.
Patients in the intensive care unit after cardiovascular surgery face not only complications related to the surgical procedure but also emotional distress due to separation from their loved ones.
Because of infection control measures, visitor restrictions are enforced in intensive care units, which may further contribute to patient stress.
This study aims to evaluate the effect of scheduled virtual visitation in the intensive care environment on patients' postoperative pain, anxiety, and sleep levels.
Detailed description
Cardiovascular diseases are a group of disorders of the heart and blood vessels, causing an estimated 17.9 million deaths globally each year, and are among the leading causes of death worldwide.Coronary artery bypass graft (CABG) surgery, considered a last-resort treatment option in terms of cardiovascular disease risk factors, is a costly intervention; however, it has shown an increasing trend in its application over the past 50 years and remains the most commonly performed cardiac surgical procedure worldwide.Postoperative complications not only negatively affect the patient's recovery process but also lead to an increase in healthcare costs (9). Common issues related to surgery and anesthesia include changes in the respiratory, circulatory, and neurological systems, as well as discomfort such as pain, nausea, and vomiting.Additionally, the isolated environment of the intensive care unit can lead to various emotional problems such as delirium, anxiety, depression, spiritual distress, pain, and sleep disturbances, alongside physiological complications.
Technology provides significant convenience in all aspects of our lives. The use of technological applications in healthcare is becoming increasingly widespread and is preferred by patients, their relatives, and healthcare professionals. Surgical procedures can lead to both physical and psychological complications in patients. The fact that the patient is in a foreign environment, such as an intensive care unit, and cannot see their loved ones at will, adds an extra source of stress for the patient.
Virtual visitation in the intensive care unit is not only an easy, cost-effective, and reliable method, but it can also have positive psychological effects for both the patient and their family. The virtual visitation application can be used as an alternative option for relatives who cannot visit the hospital due to distance, cost, illness, or other responsibilities, and as a result, cannot meet with their loved one. From the patient's perspective, being able to meet with a relative at any time during treatment in the foreign and complex environment of the intensive care unit has been shown to have positive effects in the studies in the literature. However, in the related literature review, it was observed that virtual visitation was only used during the COVID-19 (Coronavirus Disease 2019) pandemic, and there were no studies that combined virtual visits with face-to-face visits. Virtual visitation should also be an alternative visitation option for patients who undergo major surgeries, such as coronary artery bypass graft (CABG) surgery, and require postoperative follow-up in the intensive care unit. No studies have been found evaluating pain, anxiety, and sleep levels in CABG patients after virtual visits, and it is expected that this study will contribute to the literature in this regard.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| The group with virtual visits | Experimental | Other: The group with virtual visitsIn this group, in addition to face-to-face visits in the intensive care unit after cardiac surgery, virtual visits were conducted with the patients' relatives via WhatsApp (a type of smartphone app) through a smartphone by the applying researcher, totaling five minutes. These visits were conducted twice on the first day after surgery, at 10:00 AM (Ante Meridiem) and 10:00 PM ( Post Meridiem)." |
| The group without virtual visits | No intervention | –In this group, patients received a face-to-face visit once a day at 1:00 PM (Post Meridiem) on the first day after surgery, according to the clinic's routine. The scales used in the study were applied at the same time interval as in the intervention group." |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 40 and above,
- Underwent elective coronary artery bypass graft surgery,
- Conscious, extubated, and hemodynamically stable,
- Glasgow Coma Scale score of 15,
- Followed in the intensive care unit for at least 48 hours after surgery,
Key exclusion criteria (4 listed)
- Patients with psychiatric disorders and using medication,
- Illiterate patients,
- Patients without a relative who can conduct the virtual visit,
- Patients with communication problems.
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 |
|---|---|---|
| The group with virtual visitsOn the first day after open-heart surgery in the intensive care unit, in addition to face-to-face visits, video calls were made through the researcher's phone in the morning and evening." | Other | The group with virtual visits |
Primary outcome
The Numeric Rating Scale
Time frame: one day
The Numerical Rating Scale is a unidimensional scale used to measure pain intensity, with numerical values ranging from 0 to 10. The patient is asked to choose the number that best reflects the pain intensity, where 0 = no pain and 10 = the worst (intolerable) pain."
1 secondary outcome
The State-Trait Anxiety Inventory"
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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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.
Gülay Karatay principal investigator
Saglik Bilimleri Universitesi
Elif Gezginci Akpınar, Assoc. Prof. study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group with virtual visits in people with Coronary Artery Disease, run by Saglik Bilimleri Universitesi 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 4 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: finished, as of the sponsor's last update on 8 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (time frame: one day). 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 8 May 2025.