UK Heatlhcare
Lexington, Kentucky, 40536, United States
NCT Number: NCT05537311
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.
Looking for future studies?
Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Lexington, Kentucky, 40536, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support
Time frame: Through completion of the intervention, which on average will occur one week after randomization
Determine the number of sessions delivered per number of sessions scheduled. The study sample size of 12 subjects to receive the intervention, and each subject in the intervention should receive 5 sessions each = 60 sessions total; success will be considered 75% of sessions delivered (45 sessions completed of 60 planned).
Time frame: Through completion of the intervention, which on average will occur one week after randomization
Minor adverse events, major adverse events, and unanticipated problems as assessed by the investigators per study protocol will be recorded during each treatment session. The rate of adverse events will be examined.
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Hospital Anxiety and Depression Scale - Anxiety- self report questionnaire with higher scores indicating worse perceived anxiety
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Hospital Anxiety and Depression Scale - Depression - self report questionnaire with higher scores indicating worse perceived depression
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
EurQol-5Domain (EQ-5D) - self report questionnaire with higher scores indicating better perceived quality of life
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Montreal Cognitive Assessment - performed cognitive examination with higher scores indicating better cognitive function
Kirby Mayer
Other
Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial
Acronym: SOCIAL
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.
Published trials that share one or more normalized conditions with this study.
NCT04041401
Anxiety, Anxiety Disorders
Tooting, United Kingdom
View Trial DetailsNCT03226912
Anxiety, Anxiety Disorders
Melbourne, Victoria, Australia
View Trial DetailsNCT07372586
Anxiety, Anxiety Disorders
Charleston, South Carolina, United States
View Trial DetailsNCT04921631
Anxiety Disorders, Behavior
Pittsburgh, Pennsylvania, United States
View Trial Details