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Completed

NCT Number: NCT06961539

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamidiye Institute of Health Sciences, University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The group with virtual visits

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."

Primary outcomes

  1. 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."

Secondary outcomes

  1. The State-Trait Anxiety Inventory"

    Time frame: one day

    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.

Other outcomes

  1. The Richard-Campbell Sleep Scale

    Time frame: two day

    The scale consists of six items that assess factors affecting sleep patterns, such as the depth of night sleep, sleep onset latency, frequency of awakenings, duration of wakefulness, sleep quality, and the noise level in the environment. The scale score ranges from "0-25," indicating "very poor sleep," to "76-100," indicating "very good sleep." The total score evaluation is based on five items, with the sixth item not included in the total score calculation. The higher the scale score, the more positive the improvement in the individual's sleep quality.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect on Pain, Anxiety and Sleep Levels of Virtual Visiting in the Cardiovascular Surgery Intensive Care Unit: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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