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临床试验/NCT06961539
NCT06961539已完成不适用

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

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
The Numeric Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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."

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)."

干预措施: The group with virtual visits (Other)

结局指标

主要结局

The Numeric Rating Scale

时间窗: 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."

次要结局

  • The State-Trait Anxiety Inventory"(one day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülay Karatay

Graduate Student

Saglik Bilimleri Universitesi

研究点 (1)

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