Clinical trial NCT06961539: "The Effect of Virtual Visitation in the Intensive Care Unit on Pain, Anxiety, and Sleep Levels"
Official title: The Effect on Pain, Anxiety and Sleep Levels of Virtual Visiting in the Cardiovascular Surgery Intensive Care Unit: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Pain
Cardiovascular surgery
Anxiety
virtual visiting
sleep
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with psychiatric disorders and using medication,
* Illiterate patients,
* Patients without a relative who can conduct the virtual visit,
* Patients with communication problems.

Primary outcomes:
measure: The Numeric Rating Scale
timeFrame: one day
Secondary outcomes:
measure: The State-Trait Anxiety Inventory"
timeFrame: one day
Other outcomes:
measure: The Richard-Campbell Sleep Scale
timeFrame: two day
Locations:
city: Istanbul
country: Turkey
facility: Hamidiye Institute of Health Sciences, University of Health Sciences
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Gülay Karatay
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci Akpınar, Assoc. Prof.
role: STUDY_DIRECTOR
References: