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

NCT06961539 | Completed

• 1 other identifier: SBU-SBF-GK-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Pain; Cardiovascular surgery; Anxiety; virtual visiting; sleep

Outcome Measures

Primary Outcomes (1)

• 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."

  one day

Secondary Outcomes (1)

• The State-Trait Anxiety Inventory"

  one day

Other Outcomes (1)

• The Richard-Campbell Sleep Scale

  two day

Study Arms (2)

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)."

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."

Interventions

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."

The group with virtual visits

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Hamidiye Institute of Health Sciences, University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülay Karatay

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Elif Gezginci Akpınar, Assoc. Prof.

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: October 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)