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Virtual reality and sound therapy may shield your brain during heart surgery

NCT ID NCT05036538

Symptom relief Sponsor: Heart and Brain Research Group, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether relaxing before heart surgery using virtual reality nature scenes or special sound patterns (binaural beats) can reduce stress and prevent problems like confusion or memory loss after the operation. About 125 adults having planned heart surgery will be randomly assigned to one of three relaxation methods or standard care. The goal is to see if these simple, non-drug approaches can protect mental function after a major procedure.

What this could mean

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

Active substance
virtual reality and binaural beats
What this could lead to
If it works, this could offer a simple, drug-free way to lower the risk of confusion and memory problems after heart surgery.
What could go wrong
This is a small, early-stage trial (125 people) testing a relaxation technique, not a proven treatment. The effect on preventing delirium may be small or not work at all.

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 125 people

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

Started

Jul 2023

Expected to finish

Nov 2028

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: 1. Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation. 2. A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent. Exclusion Criteria: 1. History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation. 2. Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy), 3. Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli. 4. Taking sedatives on the day of surgery. 5. Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons. 6. Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team. 7. Participation in an interventional study according to AMG/MPG will also be excluded. 8. Patients with missing informed consent.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium Postoperative Cognitive Complications

As listed by the trial registrant

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

Postoperative cognitive dysfunction Postoperative delirium Preoperative stress

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kerckhoff Heart Center, Heart and Brain Research Group

    RECRUITING

    Bad Nauheim, Hesse, 61231, Germany

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