Using Breathing Techniques to Ease Anxiety in ICU Patients Awaiting Heart Transplants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHartford HealthCare
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
any gender
any race/ethnicity
≥18 years old with no upper limit
currently inpatient in the cardiac ICU, awaiting heart transplant
Disqualifiers
<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
Trial design
Design model
Single group
Treatments tested in this trial
Heart Rate Variability Biofeedback (HRVB)
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Heart Rate Variability Biofeedback for Anxiety Reduction in ICU Heart Transplant Candidates"Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-intervention) and after 2 weeks (post-intervention)Secondary outcomes
1
Cardiac Anxiety Questionnaire
Standardized self-report measure of anxiety Contains 18 items, each rated on a 0-5 Likert scale (0 = never, 5 = always). Total score is the mean of all items. Minimum possible mean score: 0 Maximum possible mean score: 5 Higher CAQ scores = greater cardiac anxiety (worse outcome)
Time frame
Baseline (pre-intervention) and after 2 weeks (post-intervention)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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