RecruitingNot ApplicableNCT05197972

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

296 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Surgery Oncology

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining heart rate coherence breathing exercises with medical hypnosis (a focused relaxation technique) can reduce anxiety before cancer surgery. Participants use a smartphone app leading up to their operation. **You may be eligible if...** - You are 18 or older - You have cancer (confirmed or suspected) and are scheduled for surgery - Your surgery requires general or local/regional anesthesia - You have a smartphone, tablet, or computer and can install an app - You are enrolling at least 7 days before your surgery - You are covered by French social security **You may NOT be eligible if...** - Your surgery is an emergency - You are having plastic surgery for reconstruction or prophylactic (preventive) surgery - You have a resting heart rate below 50 beats per minute and take beta-blockers - You have severe heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERcardiac 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).