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Clinical Trials in France / NCT05197972
Recruiting Not applicable

Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery

NCT05197972 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-06-01
Last updated
2025-04-16

Condition(s) studied

SurgeryOncology

Investigational drug(s) / intervention(s)

cardiac coherence program coupled with hypnosis

cardiac coherence program coupled with hypnosis: At home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application "Respirelax": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days. An audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape).

Study summary

The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Institut régional du cancer de Montpellier Montpellier Hérault 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

More Institut du Cancer de Montpellier - Val d'Aurelle trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197972 on ClinicalTrials.gov ↗ ← All trials in France