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Évaluation de la cohérence cardiaque associée à l'hypnose médicale sur l'anxiété préopératoire en chirurgie oncologique (COHEC2)

5 novembre 2026 mis à jour par: Institut du Cancer de Montpellier - Val d'Aurelle

Etude de phase III évaluant un programme d'intervention non médicamenteuse (NDI) par respiration guidée à fréquence fixe (cohérence cardiaque) associée à l'hypnose médicale sur l'anxiété préopératoire en chirurgie oncologique

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

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The perioperative period is recognized as anxiety-provoking for most patients. In oncology, 60 to 80% of patients suffer from stress throughout their treatment. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention.

For many years, pharmacological premedication, especially with benzodiazepines, has been the gold standard for the treatment of preoperative anxiety, but this systematic prescription is increasingly controversial, especially in populations most exposed to side effects, such as elderly subjects and patients with cardiac or respiratory pathologies.

The aim of this study is to propose an alternative to pharmacological premedication by a non-drug approach.

The two techniques (the Fixed Rate Guided Breathing Technique = cardiac coherence and hypnosis) can potentiate each other and become synergistic. Thus, for patients undergoing oncological surgery, regular practice of cardiac coherence coupled with hypnosis prior to their surgery should enable them to better manage perioperative anxiety and thus significantly reduce their level of anxiety on the day of their surgery.

The association of the 2 techniques combines several advantages:

  • It is totally "physiological", free and immediately available for the patient and without any undesirable effect;
  • It gives autonomy to the patient to manage his stress, making him independent of chemical molecules, the presence of a third party or expensive equipment.
  • It will allow oncology patients to use it throughout their care (invasive examinations, MRI imaging, heavy and complex care such as certain dressings, etc.)

This work will allow:

  • To give oncology patients the possibility to be actors of their care by a self-management of their anxiety in substitution or complement of a medicated approach;
  • To map anxiety in oncology surgery using a simple scale such as the EVA, which has not yet been done;
  • To identify the most anxious patients in order to provide them with the appropriate management (pharmacological and/or NMI) before their surgery;
  • To evaluate the correlation between the level of preoperative anxiety and the occurrence of postoperative adverse events;
  • To evaluate the correlation between the level of anxiety and the quality of recovery (QoR) and the postoperative experience (EVAN-G).

Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.

Type d'étude

Interventionnel

Inscription (Réel)

332

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Lyon, France
        • Centre Léon Bérard
      • Toulouse, France
        • Institut Universitaire du Cancer Toulouse - Oncopole
      • Villejuif, France
        • Institut Gustave Roussy
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Institut régional du cancer de Montpellier

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental group

Classic management of the preoperative period with a 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).

Aucune intervention: Control group

Classic management of the preoperative period

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Visual Analogue Scale (VAS) of global anxiety
Délai: The morning of the surgery (Day 0) upon arrival in the operating room

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).

The morning of the surgery (Day 0) upon arrival in the operating room

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Program compliance
Délai: Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)

Program compliance rate of patients in the experimental group. A patient is considered compliant if he declares to have completed at least 2/3 of the proposed Cardiac Coherence sessions + listening to hypnotic tape (at least 5 days /7).

Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)
Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)
Délai: Between -15 to -7 days before surgery (Day -15 to Day -7)

Visual Analogue Scale (VAS) of anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety). The patient assesses his global and specific anxiety related to: surgery, anesthesia, COVID infectious risk, fear of the unknown, oncological disease

Between -15 to -7 days before surgery (Day -15 to Day -7)
Measurement of global anxiety level by using a Visual Analogue Scale (VAS)
Délai: Between -15 to -7 days before surgery and the day of surgery (Day 0)

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).

Between -15 to -7 days before surgery and the day of surgery (Day 0)
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Délai: Between -15 to -7 days before surgery

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-report questionnaire comprising six questions that have been developed and validated to evaluate the preoperative anxiety of patients. This global index assesses three separate areas: anxiety about anaesthesia, anxiety about surgery, and the desire for information.

The scale scores six items from 1 to 5 (1 = absence, 5 = extreme). The APAIS scale will be used to determine the psychological profile of patients between "blunting" and "monitoring" types

Between -15 to -7 days before surgery
VAS values and individual psycho-clinical characteristics
Délai: Between -15 to -7 days before surgery and the day of surgery (Day 0)

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety) (defined as VAS at Day 0 ≥ 40), and individual psycho-clinical characteristics (gender, smoking, psychological questionnaires).

Between -15 to -7 days before surgery and the day of surgery (Day 0)
Number of patients taking benzodiazepine
Délai: The day after surgery (Day 1)

Rate of patients taking benzodiazepines in the 2 groups

The day after surgery (Day 1)
Number of days of hospitalization
Délai: The day after surgery (Day -1) and up to 1 month

Length of hospital stay in the 2 groups

The day after surgery (Day -1) and up to 1 month
VAS values and mode of hospitalization and importance of the surgical procedure
Délai: The morning of the surgery (Day 0) upon arrival in the operating room

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor, and the mode of hospitalization (ambulatory or conventional) and the importance of the surgical procedure (minor, intermediate or major)

The morning of the surgery (Day 0) upon arrival in the operating room
Doses of hypnotic and morphine drugs
Délai: During anesthetic induction (Day 0)

Doses of hypnotic and morphine drugs administered during anesthetic induction (Day 0) in the 2 groups

During anesthetic induction (Day 0)
Value of preoperative VAS and adverse events
Délai: The morning of the surgery (Day 0) upon arrival in the operating room

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor and adverse event variables: pain, agitation, postoperative nausea and vomiting (PONV), ...

The morning of the surgery (Day 0) upon arrival in the operating room
Number of Self-questionnaire completed
Délai: From the day of the anesthesia consultation until the end of the study

Self-questionnaire completion rates for each of the 2 pre- and postoperative periods

From the day of the anesthesia consultation until the end of the study
Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)
Délai: Two day after surgery (Day 2)

The EVAN-G questionnaire includes 26 questions whose results are grouped together to define 6 dimensions: Attention Focus, Information, Privacy, Pain, Discomfort and Wait Times. From these scores, an overall satisfaction score is calculated. The total score of the six dimensions reduced to 100.

Two day after surgery (Day 2)
Visual Analogue Scale (VAS) of pain
Délai: At 1, 2 and 3 month after surgery

Visual Analogue Scale (VAS) of pain is a pain self-assessment scale that allows the patient to self-assess his or her pain using a cursor

At 1, 2 and 3 month after surgery
Quality of Recovery (QoR)
Délai: The day after surgery (Day 1)

The QoR-15 questionnaire assesses five dimensions of recovery : physical comfort; emotional state; physical independence; physiological support; and pain. Each item was rated on a ten-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score of 15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).

The day after surgery (Day 1)
Insomnia Severity Index Scale (ISI)
Délai: The day after surgery (Day 1)

The Insomnia Severity Index (ISI) includes 7 questions which assesses the nature of the insomnia, the person's satisfaction with sleep, daily functioning and anxiety about sleep problems. Add scores for all seven items, sum from 0-7 = No clinically significant insomnia to 22-28 = Clinical insomnia (severe).

The day after surgery (Day 1)
VAS of on satisfaction with overall management and anesthesia
Délai: The day after surgery (Day 1)

Visual Analogue Scale (VAS) of on satisfaction with overall management and anesthesia is a satisfaction self-assessment scale that allows the patient to self-assess his or her satisfaction using a cursor. The scale ranges from 0 (not at all satisfied) to 100 (completely satisfied)

The day after surgery (Day 1)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Régis FUZIER, MD, Institut Universitaire du Cancer Toulouse - Oncopole
  • Chercheur principal: Lauriane Bordevane, MD, Gustave Roussy, Cancer Campus, Grand Paris
  • Chaise d'étude: Jibba AMRAOUI, MD, Institut régional du cancer de Montpellier

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2022

Achèvement primaire (Réel)

30 juillet 2026

Achèvement de l'étude (Réel)

30 septembre 2026

Dates d'inscription aux études

Première soumission

8 décembre 2021

Première soumission répondant aux critères de contrôle qualité

14 janvier 2022

Première publication (Réel)

20 janvier 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • PROICM 2021-09 COH
  • 2021-A01524-37 (Identificateur de registre: ID RCB)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Délai de partage IPD

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

Critères d'accès au partage IPD

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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