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

Not Applicable

Recruiting

• Conditions: Surgery; Oncology
• Interventions: Other: cardiac coherence program coupled with hypnosis

• Registration Number: NCT05197972
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-20
• Study Start: 2022-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	cardiac coherence program coupled with hypnosis	Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) of global anxiety	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).

Secondary Outcome Measures

Name	Time	Method
Doses of hypnotic and morphine drugs	During anesthetic induction (Day 0)	Doses of hypnotic and morphine drugs administered during anesthetic induction (Day 0) in the 2 groups
Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)	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
Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)	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.
Visual Analogue Scale (VAS) of pain	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
Quality of Recovery (QoR)	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).
Insomnia Severity Index Scale (ISI)	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).
VAS of on satisfaction with overall management and anesthesia	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)
Program compliance	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).
Number of patients taking benzodiazepine	The day after surgery (Day 1)	Rate of patients taking benzodiazepines in the 2 groups
Measurement of global anxiety level by using a Visual Analogue Scale (VAS)	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).
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)	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
VAS values and individual psycho-clinical characteristics	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).
Number of days of hospitalization	The day after surgery (Day -1) and up to 1 month	Length of hospital stay in the 2 groups
Value of preoperative VAS and adverse events	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), ...
Number of Self-questionnaire completed	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
VAS values and mode of hospitalization and importance of the surgical procedure	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)

Trial Locations

Locations (4)

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut régional du cancer de Montpellier; 🇫🇷 Montpellier, Hérault, France

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France