NCT05197972 Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
| NCT ID | NCT05197972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 296 participants in total. It began in 2022-06-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
Eligibility 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
Contact & Investigator
Jibba AMRAOUI, MD
STUDY CHAIR
Institut régional du cancer de Montpellier
Frequently Asked Questions
Who can join the NCT05197972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05197972 currently recruiting?
Yes, NCT05197972 is actively recruiting participants. Contact the research team at jean-pierre.bleuse@icm.unicancer.fr for enrollment information.
Where is the NCT05197972 trial being conducted?
This trial is being conducted at Montpellier, France, Lyon, France, Toulouse, France, Villejuif, France.
Who is sponsoring the NCT05197972 clinical trial?
NCT05197972 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Jibba AMRAOUI, MD at Institut régional du cancer de Montpellier. The trial plans to enroll 296 participants.