Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
NCT ID: NCT05197972
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
296 participants
INTERVENTIONAL
2022-06-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental group
Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis.
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).
Control group
Classic management of the preoperative period
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Jibba AMRAOUI, MD
Role: STUDY_CHAIR
Institut régional du cancer de Montpellier
Régis FUZIER, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Universitaire du Cancer Toulouse - Oncopole
Lauriane Bordevane, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut régional du cancer de Montpellier
Montpellier, Hérault, France
Centre Léon Bérard
Lyon, , France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Munoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42.
Agelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006. doi: 10.1097/00003246-200205000-00008.
Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
Jiang H, White MP, Greicius MD, Waelde LC, Spiegel D. Brain Activity and Functional Connectivity Associated with Hypnosis. Cereb Cortex. 2017 Aug 1;27(8):4083-4093. doi: 10.1093/cercor/bhw220.
McCraty R, Atkinson M, Tiller WA, Rein G, Watkins AD. The effects of emotions on short-term power spectrum analysis of heart rate variability. Am J Cardiol. 1995 Nov 15;76(14):1089-93. doi: 10.1016/s0002-9149(99)80309-9.
Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.
Amraoui J, Bordenave L, Leclerc G, Salvignol G, Jarlier M, Fiess C, Philibert L, Fuzier R, Touraine C. Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol. BMJ Open. 2023 Dec 12;13(12):e072215. doi: 10.1136/bmjopen-2023-072215.
Related Links
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2\. Amouroux R, Rousseau-Salvador C, Annequin D. L'anxiété préopératoire: manifestations cliniques, évaluation et prévention. Ann Méd-PsycholRevPsychiatr; 2010; 168:588-92
Servant D, Lebeau JC, Mouster Y et al. Cardiac variability, a good indicator of emotion regulation. Journal of cognitive behavioral therapy 2008; 18: 45-8.
Robert B. Measurement of preoperative anxiety by the visual analog scale. UE7: Professional thesis for the State Diploma of nurse anesthetist. CHU Poitiers
Other Identifiers
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2021-A01524-37
Identifier Type: REGISTRY
Identifier Source: secondary_id
PROICM 2021-09 COH
Identifier Type: -
Identifier Source: org_study_id
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