Using cardiac coherence and hypnosis to reduce preoperative anxiety in cancer surgery
Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
This study is testing whether using heart-focused breathing techniques with hypnosis can help reduce anxiety in patients about to have cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Locations | 4 sites (Montpellier, Hérault and 3 other locations) |
| Trial ID | NCT05197972 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of combining cardiac coherence techniques with hypnosis to alleviate preoperative anxiety in patients undergoing oncological surgery. The approach seeks to provide a non-pharmacological alternative to traditional anxiety management methods, which often involve benzodiazepines that can have undesirable side effects. By practicing cardiac coherence and hypnosis, patients may gain better control over their anxiety levels leading up to surgery. The study will include patients who are scheduled for surgery and will assess their anxiety levels before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for surgery related to cancer and can engage with the required technology.
Not a fit: Patients undergoing emergency surgeries or those with specific cardiac or respiratory conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce preoperative anxiety for cancer patients, improving their overall surgical experience.
How similar studies have performed: While the combination of cardiac coherence and hypnosis is a novel approach, similar non-pharmacological interventions have shown promise in reducing anxiety in various medical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old 2. Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization 3. Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone 4. Patient with a smartphone or a tablet or a computer and able to install the application 5. Inclusion of the patient minimum 7 days before the date of the surgery 6. Patient who signed the informed consent 7. Patient affiliated to a French social security system Exclusion Criteria: 1. Emergency surgery 2. Plastic surgery for reconstruction: lipomodelling 3. Prophylactic surgery: no suspected or existing cancer 4. Bradycardia (\< 50 beats/minute) with β-blockers 5. Severe heart failure with ventricular ejection fraction \< 40% 6. Uncontrolled chronic pain for more than three months on morphine 7. Patient with unstable epilepsy or respiratory pathology with rest dyspnea 8. Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ... 9. Medical (neurological, psychiatric, etc.) or psychological conditions not allow for participation in the protocol (completion of questionnaires and booklet, compliance with the cardiac coherence program coupled with hypnosis) 10. Deaf patient without hearing aids 11. Patient under guardianship or curatorship
Where this trial is running
Montpellier, Hérault and 3 other locations
- Institut régional du cancer de Montpellier — Montpellier, Hérault, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Régis FUZIER, MD — Institut Universitaire du Cancer Toulouse - Oncopole
- Study coordinator: Jean-Pierre BLEUSE, MD
- Email: jean-pierre.bleuse@icm.unicancer.fr
- Phone: 4 67 61 31 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.