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Breathe away the fear: new study tests simple technique for heart transplant anxiety

NCT ID NCT07381023

Symptom relief Sponsor: Hartford HealthCare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a guided breathing technique called heart rate variability biofeedback (HRVB) can reduce anxiety in 60 adults who are in the ICU waiting for a heart transplant. Participants will use a biofeedback device or app during a single session led by a trained clinician. The goal is to see if this simple, non-drug approach helps patients feel calmer and more in control during a very stressful time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heart Rate Variability Biofeedback (HRVB) - a guided breathing technique using a biofeedback device or app
What this could lead to
If it works, this could offer a simple, drug-free way to help heart transplant candidates manage anxiety while in the ICU.
What could go wrong
This is a very small, early-stage study with only 60 participants. The intervention is a single session, so any benefits may be short-lived. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. * able/willing to consent to participate Exclusion Criteria * \<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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Heart transplant patients

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.