Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05197972

Phase III Study of Cardiac Coherence Breathing and Medical Hypnosis to Reduce Preoperative Anxiety in Cancer Surgery

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-04-16

296

Participants Needed

4

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how combining cardiac coherence, a guided breathing technique, with medical hypnosis may help reduce anxiety before surgery in cancer patients. This approach aims to offer a non-drug alternative to usual medications like benzodiazepines, which can have side effects, especially in older adults or those with heart or lung problems. The study focuses on patients undergoing oncological surgery who often experience significant stress during their treatment. Participants in the experimental group will be taught to perform cardiac coherence sessions at home using the Respirelax app, practicing three 5-minute sessions daily for 7 to 15 days before surgery. They may also listen to a hypnotic audio tape during or separate from these sessions. The control group will receive the standard preoperative care without these techniques. Throughout the study, patients will be assessed for anxiety levels using scales like the Visual Analogue Scale (VAS) and Amsterdam Preoperative Anxiety and Information Scale (APAIS) starting up to 15 days before surgery and on the day of surgery. Researchers will monitor recovery quality, pain levels, medication use, and hospitalization length. Patients will complete questionnaires and diaries to track their experience and adherence, with safety and postoperative outcomes also evaluated up to three months after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled for cancer surgery with classic or ambulatory hospitalization
  • Requires general anesthesia with or without regional anesthesia, or regional anesthesia alone
  • Has access to a smartphone, tablet, or computer and can install the application
  • Included at least 7 days before surgery
  • Signed informed consent
  • Affiliated with French social security system
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Plastic surgery for reconstruction such as lipomodelling
  • Prophylactic surgery without suspected or existing cancer
  • Bradycardia less than 50 beats per minute with beta-blockers
  • Severe heart failure with ventricular ejection fraction below 40%
  • Uncontrolled chronic pain on morphine for more than three months
  • Unstable epilepsy or respiratory disease with resting shortness of breath
  • Regular practice of relaxation techniques like yoga, hypnosis, sophrology, meditation, music therapy, or virtual reality
  • Medical or psychological conditions preventing participation in the protocol
  • Deafness without hearing aids
  • Under guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Cardiac Coherence and Hypnosis Practice

Duration - 7 to 15 days before surgery

Participants in the experimental group practice a cardiac coherence breathing program coupled with hypnosis at home before surgery to manage preoperative anxiety.

Daily home sessions (3 sessions per day, 5 minutes each)

Surgery

Duration - Day of surgery

Participants undergo their planned oncological surgery under general or regional anesthesia.

1 visit (in-person, day of surgery)

Postoperative Assessment

Duration - From day after surgery up to 3 months

Participants are assessed for anxiety, pain, recovery quality, and medication use following surgery.

Assessments on Day 1, Day 2, and at 1, 2, and 3 months after surgery

Trial Site Locations

Total: 4 locations

1

Institut régional du cancer de Montpellier

Montpellier, Hérault, France, 34298

Actively Recruiting

2

Centre Léon Bérard

Lyon, France

Actively Recruiting

3

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

Not Yet Recruiting

4

Institut Gustave Roussy

Villejuif, France

Not Yet Recruiting

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Research Team

J

Jean-Pierre BLEUSE, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam.

Marcus W Agelink, Thomas B Majewski, Jürgen Andrich...

https://pubmed.ncbi.nlm.nih.gov/12006794