Improved recovery following cardiac surgery through audio-visual experience
| ISRCTN | ISRCTN12556414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12556414 |
| Sponsor | University Hospital of Geneva |
| Funders | Hôpitaux Universitaires de Genève, Schmieder-Bohrisch Foundation |
- Submission date
- 27/03/2026
- Registration date
- 30/03/2026
- Last edited
- 08/05/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
After cardiac (heart) surgery, the body reacts to the stress of the operation, which can increase inflammation and make pain feel worse. This study aims to find out whether a relaxing audio-visual experience (combining calming sounds and images) can help improve recovery after heart valve surgery by reducing pain and stress.
Who can participate?
Adults scheduled to undergo planned (elective) aortic valve replacement or aortic valve repair surgery.
What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive a relaxing audio-visual experience designed to promote calmness, while the other group will receive standard care without this intervention. Researchers will compare the two groups by measuring pain levels, stress levels, and biological markers of stress, relaxation, and inflammation using saliva and blood samples. Participation will last up to six days after surgery.
What are the possible benefits and risks of participating?
Participants in the intervention group may experience reduced pain and stress, although this cannot be guaranteed. There are no significant risks expected beyond standard care, as the intervention involves non-invasive audio-visual relaxation. Some participants may find the experience unfamiliar or not helpful.
Where is the study run from?
Geneva University Hospitals (HUG), Switzerland.
When is the study starting and how long is it expected to run for?
The study is expected to begin in May 2026 and will run for approximately one year.
Who is funding the study?
The study is funded by the Schmieder-Bohrisch Foundation and the Cardiovascular Surgery Division of the Surgery Department at HUG, Switzerland.
Who is the main contact?
Prof Professor Christoph Huber, Head of Cardiovascular Surgery Division, Department of Surgery at HUG (Sponsor-Investigator), christoph.huber@hug.ch.
Contact information
Principal investigator
Cardiovascular Surgery Division
Geneva University Hospitals (HUG)
Rue Gabrielle-Perret Gentile 4
Geneva
1205
Switzerland
 ORCID ID |
0000-0001-9048-849X |
|---|---|
| Phone | +41 22 372 76 25 |
| christoph.huber@hug.ch |
Scientific
Service de cardiologie
Hôpitaux Universitaires de Genève
Rue Gabrielle Perret Gentil 4
Geneva
1205
Switzerland
| ORCID ID |
0000-0003-1680-0152 |
|---|---|
| Phone | +4179 553 2615 |
| elena.tessitore@hug.ch |
Public
Cardiovascular Surgery Division
Geneva University Hospitals (HUG)
Rue Gabrielle-Perret Gentile 4
Geneva
1205
Switzerland
| ORCID ID |
0000-0002-2914-066X |
|---|---|
| Phone | +41 79 553 9870 |
| daniela.dumitriulagrange@hug.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Dose comparison |
| Assignment | Parallel |
| Purpose | Basic science, Supportive care |
| Scientific title | A patient-centered approach to improve recovery following cardiac surgery through audio-visual experience – a proof-of-concept randomized controlled trial |
| Study objectives | The overarching hypothesis is that by using state-of-the-art technology to deliver positive, calming audio-visual stimuli in the context of perioperative care, the study will provide an environment conducive to enhanced patient recovery. Unlike other studies, in which the access to relaxation, as an intervention, was administered on a “prescription” basis, with pre-specified duration or sound frequency, this study posits that the "one size fits all" approach is an inefficient method of assisting patients in achieving a state of calm and comfort. In this study, patients are permitted and encouraged to select the type of audio-visual support, its timing, and its duration, according to their needs, for a maximal psychological and physiological effect. The objective of this proof-of-concept study is to evaluate the changes in postoperative pain levels associated with this intervention. In addition, the study aims to evaluate changes in physiological endpoints and in self-evaluated stress levels. This proof-of-concept study will also provide us information about the feasibility of testing this intervention in larger RCT, powered for investigating other important outcomes following cardiac surgery. |
| Ethics approval(s) |
Submitted 28/01/2026, Swissethics Cantonal Research Ethics Commission (Swissethics Commission cantonale d'éthique de la recherche; CCER) (Rue Adrien-Lachenal 8, Geneva, 1207, Switzerland; +41 22 546 51 01; ccer@etat.ge.ch), ref: 2026-00172 |
| Health condition(s) or problem(s) studied | Recovery following adult patients undergoing elective cardiac surgery for aortic valve repair or aortic valve replacement |
| Intervention | Randomization will be performed using a computer program: a list for stratified block randomization will be generated in R and uploaded to REDCap. Intervention: Allowing the patient to self-adjust to a state of psychological comfort and calm, through unrestricted access to a set of relaxing audio- or audio-visual stimuli, from the day before surgery and until postoperative day 5, as long as this is not impeding the delivery of standard of care: - The utilization of noise-cancelling headphones to facilitate the absorption of nature derived sounds and calming music. A curated selection of several nature sounds, including forest and bird sounds, ocean waves, and river sounds, along with peaceful, relaxing music will be made available to each participant. - Immersive three-dimensional virtual reality experiences featuring natural environments including forests, high mountains, and ocean beaches, are available. These sessions have a duration of 20 minutes, with a one-hour washout period recommended by the manufacturer between each session. Patients have the option to listen to a virtual voice (feminine or masculine) that guides their respiratory motion and relaxation, as this feature is available on HypnoVR devices. The HypnoVR device is CE marked as a Class 1 Medical Device, for use as a non-drug digital therapy in various medical fields like surgery and dentistry, ISO 13485 certified for quality management systems. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/08/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Adult patients 2. Undergoing elective cardiac surgery for aortic valve repair or aortic valve replacement 3. Signed the informed consent form for participating in the study |
| Key exclusion criteria | 1. Failure or inability to provide consent for participation in the study 2. Pregnant 3. Under the age of 18 4. Contraindications to headphones (eg. Cochlear implants, active infection) 5. History of psychotic symptoms or severe mental illness (e.g., schizophrenia, bipolar disorder) 6. History of seizures or uncontrolled epilepsy 7. Motion sickness or vestibular disorders 8. Significant visual or auditory impairment that would interfere with the experience 9. Claustrophobia 10. Chronic gastrointestinal disease 11. Metabolic disorders: diabetes, autoimmune thyroid disease (graves'), vipomas 12. Autoimmune disorders: multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis, spondyloarthritis |
| Date of first enrolment | 15/08/2026 |
| Date of final enrolment | 31/05/2027 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Editorial Notes
08/05/2026: The date of first enrolment was changed from 15/05/2026 to 15/08/2026.
30/03/2026: Study’s existence confirmed by the Swissethics Cantonal Research Ethics Commission (Swissethics Commission cantonale d'éthique de la recherche; CCER), Switzerland.
