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

NCT05197972 | Recruiting

• 2 other identifiers: PROICM 2021-09 COH2021-A01524-37
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Surgery; Oncology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Program compliance

  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)

  Between -15 to -7 days before surgery (Day -15 to Day -7)

• 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)

• The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  Between -15 to -7 days before surgery

• VAS values and individual psycho-clinical characteristics

  Between -15 to -7 days before surgery and the day of surgery (Day 0)

Study Arms (2)

Experimental group

EXPERIMENTAL

Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis.

Other: cardiac coherence program coupled with hypnosis

Control group

NO INTERVENTION

Classic management of the preoperative period

Interventions

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient who signed the informed consent
• Patient affiliated to a French social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (4)

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, France

NOT YET RECRUITING

Related Publications (16)

• 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 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.

  PMID: 1854034 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.

  PMID: 11207465 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.

  PMID: 515298 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.

  PMID: 6886967 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.

  PMID: 10702461 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.

  PMID: 8317718 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.

  PMID: 8939044 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.

  PMID: 1606095 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.

  PMID: 12006794 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.

  PMID: 25734733 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.

  PMID: 25101026 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.

  PMID: 27469596 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.

  PMID: 7484873 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.

  PMID: 30646110 BACKGROUND

• 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.

  PMID: 38086587 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Neoplasms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jibba AMRAOUI, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

• Régis FUZIER, MD

  Institut Universitaire du Cancer Toulouse - Oncopole

  PRINCIPAL INVESTIGATOR

• Lauriane Bordevane, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Pierre BLEUSE, MD

CONTACT

4 67 61 31 02; jean-pierre.bleuse@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 20, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
• Access Criteria: 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.

Locations

FR (4)