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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01524-37 | Registry Identifier | ID RCB |
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The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
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:
This work will allow:
Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis. |
|
| Control group | No Intervention | Classic management of the preoperative period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac coherence program coupled with hypnosis | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) of global anxiety | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program compliance | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pierre BLEUSE, MD | Contact | 4 67 61 31 02 | +33 | jean-pierre.bleuse@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jibba AMRAOUI, MD | Institut régional du cancer de Montpellier | Study Chair |
| Régis FUZIER, MD | Institut Universitaire du Cancer Toulouse - Oncopole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut régional du cancer de Montpellier | Recruiting | Montpellier | Hérault | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16438017 | Background | 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. | |
| 1854034 | Background | 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. |
| Label | URL |
|---|---|
| 2\. Amouroux R, Rousseau-Salvador C, Annequin D. L'anxiété préopératoire: manifestations cliniques, évaluation et prévention. Ann Méd-PsycholRevPsychiatr; 2010; 168:588-92 | View source |
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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.
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
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.
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Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis
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| Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS) | 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) | 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) | 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 | 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 | Rate of patients taking benzodiazepines in the 2 groups | The day after surgery (Day 1) |
| Number of days of hospitalization | 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 | 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 | 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 | 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 | 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) | 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 | 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) | 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) | 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 | 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) |
| Lauriane Bordevane, MD |
| Gustave Roussy, Cancer Campus, Grand Paris |
| Principal Investigator |
| Centre Léon Bérard | Recruiting | Lyon | France |
|
| Institut Universitaire du Cancer Toulouse - Oncopole | Not yet recruiting | Toulouse | France |
|
| Institut Gustave Roussy | Not yet recruiting | Villejuif | France |
|
| 11207465 | Background | 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. |
| 515298 | Background | 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. |
| 6886967 | Background | 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. |
| 10702461 | Background | 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. |
| 8317718 | Background | 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. |
| 8939044 | Background | 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. |
| 1606095 | Background | 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. |
| 12006794 | Background | 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. |
| 25734733 | Background | 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. |
| 25101026 | Background | 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. |
| 27469596 | Background | 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. |
| 7484873 | Background | 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. |
| 30646110 | Background | 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. |
| 38086587 | Derived | 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. |
| 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. | View source |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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