Reducing Isolation and Feeling of Loneliness During Critical Illness

NCT ID: NCT05537311

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-27
• Study Completion Date: 2023-07-01

Brief Summary

The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.

Detailed Description

Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone.

Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being held captive in an unknown basement." Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).

Conditions

Critical Illness; Social Isolation; Anxiety; Depression; Post Intensive Care Unit Syndrome

Study Design

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

Study Groups

Social engagement using VR

Patients will receive social engagement with emphasize on meaningful conversation, cognitive engagement, and emotional support provided by trained research assistant using virtual reality as a vehicle for delivery. Subjects will receive 15-45 minutes of treatment per day for 5 days initiated after respiratory support (Intubation via mask or tube, high-flow nasal cannula) have been weaned to nasal cannula. Experimental group will also receive standard of care

Group Type: EXPERIMENTAL

Social Engagement

Intervention Type: BEHAVIORAL

30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support

Control

Control will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Social Engagement

30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• adult
• admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)

Exclusion Criteria

• previous cognitive or emotional health condition
• inability to follow commands

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Mayer

OTHER

Sponsor Role: lead

Responsible Party

Kirby Mayer

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

UK Heatlhcare

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

77702

Identifier Type: -

Identifier Source: org_study_id