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

NCT07381023 | Not Yet Recruiting

• 1 other identifier: HHC-2025-0188
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Anxiety; Heart Transplant Patients

Keywords

Heart Transplant Candidates; Heart Rate Variability Biofeedback; Anxiety; Breathing techniques; Behavioral Health in Transplant; Cardiac Anxiety; Biofeedback Therapy

Outcome Measures

Primary Outcomes (1)

• DASS-21 Anxiety Scale (Depression Anxiety Stress Scales - 21-item short form)

  Standardized self-report measure of anxiety Each item is scored 0-3. Each subscale (Depression, Anxiety, Stress) has 7 items → raw score 0-21, then multiplied by 2 to align with DASS-42 scoring. Final score range per subscale: 0-42 (after multiplying) Higher scores = more severe symptoms.

  Baseline (pre-intervention) and after 2 weeks (post-intervention)

Secondary Outcomes (1)

• Cardiac Anxiety Questionnaire

  Baseline (pre-intervention) and after 2 weeks (post-intervention)

Study Arms (1)

Heart Rate Variability Biofeedback for Anxiety Reduction in ICU Heart Transplant Candidates"

EXPERIMENTAL

Participants in this arm 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 includes a guided breathing exercise 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 self-report anxiety assessments immediately before and after the session to evaluate changes in psychological distress. They will also receive brief instruction on how to continue using the breathing technique independently as appropriate.

Behavioral: Heart Rate Variability Biofeedback (HRVB)

Interventions

Heart Rate Variability Biofeedback (HRVB) BEHAVIORAL

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.

Heart Rate Variability Biofeedback for Anxiety Reduction in ICU Heart Transplant Candidates"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any gender
• any race/ethnicity
• ≥18 years old with no upper limit
• currently inpatient in the cardiac ICU, awaiting heart transplant
• elevated anxiety symptoms as evidenced by cut scores on the Depression, Anxiety and Stress Scale (DASS-21) and the Cardiac Anxiety Questionnaire (CAQ) (Lovibond \& Lovibond, 1995; Eifert et al., 2000).
• proficiency in speaking, reading and writing in English Participants in this study must be proficient in English due to the language limitations of the study administrator. The intervention includes a teaching component that requires verbal instruction, psychoeducation, and interactive engagement, all of which will be conducted exclusively in English. At this time, the study administrator is only proficient in English and is unable to reliably deliver the intervention or assess participant understanding in other languages. To ensure consistency, accuracy, and fidelity of the intervention, as well as to maintain ethical standards in informed consent and participant comprehension, only English-speaking individuals will be eligible to participate.

You may not qualify if:

• \<18 years of age
• active psychosis or delirium
• current neurological problems (e.g., stroke) at time of enrollment that would interfere with the ability to complete the practice
• on a ventilator at time of enrollment
• pregnancy
• unable or unwilling to consent to participate

Sponsors & Collaborators

• Hartford HealthCare: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 year after publication with no end date