Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session

NCT03981731 | Completed

• 1 other identifier: PROICM 2019-06 COH
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.

Conditions

Breast Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who have enrolled in the pre-habilitation program

  A patient will be considered to have optimally adhered to the program if she performs at least 2/3 of the proposed cardiac coherence sessions (that represents 67% of the total number of sessions), that is, at least 14 sessions over the 7 days preceding the surgery.

  7 days

Secondary Outcomes (18)

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

  7 days

• Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G)

  48 hours

• Measurement of the Postoperative Quality of Recovery (QoR)

  10 days

• Measurement of anxiety level by using a visual analogue scale

  7 days

• Measurement of wake-up quality by using a visual analogue scale

  1 day

Study Arms (1)

Cardiac coherence

EXPERIMENTAL

Other: Cardiac coherence

Interventions

Cardiac coherence OTHER

An initiation session to cardiac coherence will take place between D-10 and D-7 before the operation (during the anaesthesia consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 7 days preceding the operation. \- The anaesthetic induction will be done with a session of cardiac coherence associated with listening to the audio tape.

Cardiac coherence

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Surgery for breast or gynaecological cancer requiring scheduled hospitalization for up to 3 days
• Signing of informed consent before any specific procedure in the study
• Patient affiliated to a social security system

You may not qualify if:

• Patients undergoing outpatient surgery for their cancer will not be included
• Natural bradycardia (50 beats per minute)
• Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem
• Cardiac arrhythmias
• Severe heart failure with ventricular ejection fraction \< 40%
• Uncontrolled chronic pain
• Patients whose medical or psychological conditions do not allow them to complete the study or sign the consent
• Patient does not understand the French language
• Deaf and/or dumb patient
• Adult patient under guardianship or curatorship

Sponsors & Collaborators

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

Study Sites (1)

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

Location

Related Publications (7)

• 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

• Van den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4.

  PMID: 15845719 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

• Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.

  PMID: 16670111 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, Leclerc G, Jarlier M, Diaz J, Guler R, Demoly C, Verin C, Rey Dit Guzer S, Chalbos P, Moussion A, Taoum C, Neron M, Philibert L. Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer. BJA Open. 2024 Sep 24;12:100309. doi: 10.1016/j.bjao.2024.100309. eCollection 2024 Dec.

  PMID: 39381542 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jibba AMRAOUI, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: February 14, 2020
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Access to study data upon written detailed request sent to ICM after publication.
• Access Criteria: The data shared will be limited 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 (1)