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Effectiveness of Heart Rate Variability in Reducing Anxiety in Pre-Heart Transplant Candidates in the ICU
The goal of this clinical trial is to learn whether a breathing-based relaxation technique called heart rate variability biofeedback (HRVB) can help reduce anxiety in adult patients who are in the intensive care unit (ICU) and waiting for a heart transplant. The main questions it aims to answer are: Can HRVB reduce anxiety in patients awaiting heart transplantation in the ICU? Does HRVB help patients feel more in control of their emotions during this stressful time? Participants will: Complete a brief anxiety assessment before and after the intervention Participate in a guided HRVB session using a breathing device or app Learn how to use the technique on their own for future stress management
This is a single-group clinical trial designed to evaluate the effectiveness of heart rate variability biofeedback (HRVB) in reducing anxiety among adult patients who are currently admitted to the intensive care unit (ICU) and awaiting heart transplantation. Patients in this population often experience elevated levels of psychological distress, including anxiety and panic symptoms, due to the uncertainty of their medical condition, the high-stress ICU environment, and the emotional burden of awaiting a life-saving procedure. Heart rate variability (HRV) is a physiological marker of autonomic nervous system function and emotional regulation. HRVB is a non-invasive intervention that teaches individuals to regulate their breathing in a way that promotes optimal HRV. This technique has been shown in prior research to reduce anxiety and improve emotional resilience in various populations, but its application in critically ill transplant candidates remains underexplored. Participants in this study will complete a baseline assessment of anxiety using validated self-report measures. They will then participate in a guided HRVB session, which includes paced breathing instruction and the use of a biofeedback device or app that provides real-time feedback on heart rate and breathing patterns. Following the session, participants will complete a post-intervention assessment to evaluate changes in anxiety levels. Participants will also be encouraged to continue practicing the technique independently as appropriate. The primary outcome is the change in self-reported anxiety from pre- to post-intervention. Secondary outcomes may include changes in perceived emotional control and physiological indicators of stress. This study aims to assess the feasibility and immediate psychological benefits of HRVB in a high-acuity medical setting and to inform future research on integrative behavioral health interventions for transplant candidates.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2026
Primary Completion Date
November 1, 2027
Completion Date
December 1, 2027
Last Updated
February 2, 2026
60
ESTIMATED participants
Heart Rate Variability Biofeedback (HRVB)
BEHAVIORAL
Lead Sponsor
Hartford HealthCare
NCT07478393
NCT07456631
Data Source & Attribution
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