"The Effect of Virtual Visitation in the Intensive Care Unit on Pain, Anxiety, and Sleep Levels"

NCT ID: NCT06961539

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-03-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

The group with virtual visits

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)."

Group Type: EXPERIMENTAL

The group with virtual visits

Intervention Type: OTHER

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."

The group without virtual visits

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."

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The group with virtual visits

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."

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Gülay Karatay

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay Karatay

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Elif Gezginci Akpınar, Assoc. Prof.

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Locations

Hamidiye Institute of Health Sciences, University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU-SBF-GK-01

Identifier Type: -

Identifier Source: org_study_id