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

Official title

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

Overview

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.

Interventions

• Other 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).

Primary outcome measures

• Visual Analogue Scale (VAS) of global anxiety [Time frame: The morning of the surgery (Day 0) upon arrival in the operating room]

Secondary outcome measures (12)

• Program compliance [Time frame: 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) [Time frame: Between -15 to -7 days before surgery (Day -15 to Day -7)]
• Measurement of global anxiety level by using a Visual Analogue Scale (VAS) [Time frame: 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) [Time frame: Between -15 to -7 days before surgery]
• VAS values and individual psycho-clinical characteristics [Time frame: Between -15 to -7 days before surgery and the day of surgery (Day 0)]
• Number of patients taking benzodiazepine [Time frame: The day after surgery (Day 1)]
• Number of days of hospitalization [Time frame: The day after surgery (Day -1) and up to 1 month]
• VAS values and mode of hospitalization and importance of the surgical procedure [Time frame: The morning of the surgery (Day 0) upon arrival in the operating room]
• Doses of hypnotic and morphine drugs [Time frame: During anesthetic induction (Day 0)]
• Value of preoperative VAS and adverse events [Time frame: The morning of the surgery (Day 0) upon arrival in the operating room]
• Number of Self-questionnaire completed [Time frame: From the day of the anesthesia consultation until the end of the study]
• Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G) [Time frame: Two day after surgery (Day 2)]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old
• Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization
• Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone
• Patient with a smartphone or a tablet or a computer and able to install the application
• Inclusion of the patient minimum 7 days before the date of the surgery
• Patient who signed the informed consent
• Patient affiliated to a French social security system

Exclusion criteria

• Emergency surgery
• Plastic surgery for reconstruction: lipomodelling
• Prophylactic surgery: no suspected or existing cancer
• Bradycardia (< 50 beats/minute) with β-blockers
• Severe heart failure with ventricular ejection fraction < 40%
• Uncontrolled chronic pain for more than three months on morphine
• Patient with unstable epilepsy or respiratory pathology with rest dyspnea
• Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ...
• 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)
• Deaf patient without hearing aids
• Patient under guardianship or curatorship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 4 centers

• Institut régional du cancer de Montpellier — Montpellier
• Centre Léon Bérard — Lyon
• Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse
• Institut Gustave Roussy — Villejuif

Publications

• Pekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33. PMID 16438017
• Shevde K, Panagopoulos G. A survey of 800 patients' knowledge, attitudes, and concerns regarding anesthesia. Anesth Analg. 1991 Aug;73(2):190-8. doi: 10.1213/00000539-199108000-00013. PMID 1854034
• Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x. PMID 11207465
• Miller SM. Coping with impending stress: psychophysiological and cognitive correlates of choice. Psychophysiology. 1979 Nov;16(6):572-81. doi: 10.1111/j.1469-8986.1979.tb01523.x. No abstract available. PMID 515298
• Miller SM, Mangan CE. Interacting effects of information and coping style in adapting to gynecologic stress: should the doctor tell all? J Pers Soc Psychol. 1983 Jul;45(1):223-36. doi: 10.1037//0022-3514.45.1.223. PMID 6886967
• Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036. PMID 10702461
• Jamison RN, Taft K, O'Hara JP, Ferrante FM. Psychosocial and pharmacologic predictors of satisfaction with intravenous patient-controlled analgesia. Anesth Analg. 1993 Jul;77(1):121-5. PMID 8317718
• Kulik JA, Mahler HI, Moore PJ. Social comparison and affiliation under threat: effects on recovery from major surgery. J Pers Soc Psychol. 1996 Nov;71(5):967-79. doi: 10.1037//0022-3514.71.5.967. PMID 8939044

Identifiers

NCT: NCT05197972 · PROICM 2021-09 COH · 2021-A01524-37

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗