NCT07381023

Using Breathing Techniques to Ease Anxiety in ICU Patients Awaiting Heart Transplants

Effectiveness of Heart Rate Variability in Reducing Anxiety in Pre-Heart Transplant Candidates in the ICU

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hartford HealthCare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. 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.

Conditions

• Anxiety
• Heart Transplant Patients

Interventions

Type	Name	Description
BEHAVIORAL	Heart Rate Variability Biofeedback (HRVB)	Participants will receive a single-session heart rate variability biofeedback (HRVB) intervention while admitted to the intensive care unit (ICU) as candidates for heart transplantation. The intervention involves guided paced breathing using a biofeedback device or app that provides real-time feedback on heart rate and breathing patterns. A trained clinician will lead the session, which is designed to promote autonomic regulation and reduce anxiety. Participants will complete pre- and post-intervention self-report assessments to evaluate changes in anxiety levels. They will also receive brief instruction on how to continue using the breathing technique independently.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2026-02-02
• Last updated: 2026-03-27