COHEC2: Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle (Other)
Overall Status
Recruiting
CT.gov ID
NCT05197972
Collaborator
(none)
296
3
2
16.4
98.7
6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: cardiac coherence program coupled with hypnosis
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
296 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosisControl group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Apr 21, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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

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).

No Intervention: Control group

Classic management of the preoperative period

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) of global anxiety [The morning of the surgery (Day 0) upon arrival in the operating room]

    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).

Secondary Outcome Measures

  1. Program compliance [Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)]

    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).

  2. 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)]

    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

  3. 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)]

    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).

  4. The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Between -15 to -7 days before surgery]

    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

  5. VAS values and individual psycho-clinical characteristics [Between -15 to -7 days before surgery and the day of surgery (Day 0)]

    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).

  6. Number of patients taking benzodiazepine [The day after surgery (Day 1)]

    Rate of patients taking benzodiazepines in the 2 groups

  7. Number of days of hospitalization [The day after surgery (Day -1) and up to 1 month]

    Length of hospital stay in the 2 groups

  8. VAS values and mode of hospitalization and importance of the surgical procedure [The morning of the surgery (Day 0) upon arrival in the operating room]

    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)

  9. Doses of hypnotic and morphine drugs [During anesthetic induction (Day 0)]

    Doses of hypnotic and morphine drugs administered during anesthetic induction (Day 0) in the 2 groups

  10. Value of preoperative VAS and adverse events [The morning of the surgery (Day 0) upon arrival in the operating room]

    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), ...

  11. Number of Self-questionnaire completed [From the day of the anesthesia consultation until the end of the study]

    Self-questionnaire completion rates for each of the 2 pre- and postoperative periods

  12. Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G) [Two day after surgery (Day 2)]

    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.

  13. Visual Analogue Scale (VAS) of pain [At 1, 2 and 3 month after surgery]

    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

  14. Quality of Recovery (QoR) [The day after surgery (Day 1)]

    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).

  15. Insomnia Severity Index Scale (ISI) [The day after surgery (Day 1)]

    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).

  16. VAS of on satisfaction with overall management and anesthesia [The day after surgery (Day 1)]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥ 18 years old

  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:
  1. Emergency surgery

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut régional du cancer de Montpellier Montpellier Hérault France 34298
2 Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France
3 Institut Gustave Roussy Villejuif France

Sponsors and Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Jibba AMRAOUI, MD, Institut régional du cancer de Montpellier
  • Principal Investigator: Régis FUZIER, MD, Institut Universitaire du Cancer Toulouse - Oncopole
  • Principal Investigator: Lauriane Bordevane, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT05197972
Other Study ID Numbers:
  • PROICM 2021-09 COH
  • 2021-A01524-37
First Posted:
Jan 20, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022