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出境医 / 临床实验 / Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session (COHEC)

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

Study Description
Brief Summary:
the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.

Condition or disease Intervention/treatment Phase
Breast Cancer Gynecologic Cancer Other: Cardiac coherence Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Cardiac coherence Other: Cardiac coherence

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.


Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients who have enrolled in the pre-habilitation program [ Time Frame: 7 days ]
    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.


Secondary Outcome Measures :
  1. The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) [ Time Frame: 7 days ]
    The anxiety scale consists of six items, each of which could be scored from 1 to 5 with the end poles "not at all" (1) and "extremely" (5). The score of the anxiety scale is the sum of these four questions, with a scoring range from 6 to 30.

  2. Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G) [ Time Frame: 48 hours ]
    The validated 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 (average of all scores). For each of the scores: the higher the score, the higher the satisfaction. For each dimension, scores were reduced on a scale from 0 to 100. The higher the score, the higher the perceived quality of the experience. The total score was the sum of the scores of the six dimensions reduced to 100.

  3. Measurement of the Postoperative Quality of Recovery (QoR) [ Time Frame: 10 days ]
    The quality of postoperative functional recovery will be assessed by the QoR-15 questionnaire, which 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 on the QoR-15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).

  4. Measurement of anxiety level by using a visual analogue scale [ Time Frame: 7 days ]
    It's a visual scale from 0 (no anxiety) to 100 (highest anxiety)

  5. Measurement of wake-up quality by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (best wake-up) to 100 (worst wake-up)

  6. Measurement of post-operative pain by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no pain) to 100 (highest pain)

  7. Measurement of post-operative fatigue by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no fatigue) to 100 (highest fatigue)

  8. Measurement of comfort and satisfaction with care by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (ideal care) to 100 worst care)

  9. Number of patients taking anesthetic drugs at induction of anaesthesia [ Time Frame: 1 day ]
  10. Number of patients taking anesthetic drugs during the post-interventional monitoring [ Time Frame: 1 day ]
  11. Number of patients taking morphine in recovery room [ Time Frame: 1 day ]
  12. Number of patients taking setrons (nausea and vomiting medication) [ Time Frame: 1 day ]
  13. Rate of patients that consider continuing the program of cardiac coherence [ Time Frame: 1 day ]
  14. Rate of patients willing to recommend the technique [ Time Frame: 1 day ]
  15. Number of days of hospitalization [ Time Frame: 1 month ]
  16. Number of patients taking morphine in peroperative [ Time Frame: 1 day ]
  17. Measurement of pain at inclusion by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no pain) to 100 (highest pain)

  18. The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal. [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Layout table for location contacts
Contact: Jean-Pierre BLEUSE, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr

Locations
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France
Institut régional du cancer de Montpellier Recruiting
Montpellier, Hérault, France, 34298
Contact: Jibba AMRAOUI, MD    4 67 61 30 81 ext +33    jibba.amraoui@icm.unicancer.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: Jibba AMRAOUI, MD Institut régional du cancer de Montpellier
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE February 14, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Proportion of patients who have enrolled in the pre-habilitation program [ Time Frame: 7 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
Proportion of patients who have enrolled in the pre-habilitation program [ Time Frame: 7 days ]
A patient will be considered to have joined the program if they perform at least 80% of the proposed cardiac coherence sessions, or at least 16 sessions over the 7 days prior to surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) [ Time Frame: 7 days ]
    The anxiety scale consists of six items, each of which could be scored from 1 to 5 with the end poles "not at all" (1) and "extremely" (5). The score of the anxiety scale is the sum of these four questions, with a scoring range from 6 to 30.
  • Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G) [ Time Frame: 48 hours ]
    The validated 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 (average of all scores). For each of the scores: the higher the score, the higher the satisfaction. For each dimension, scores were reduced on a scale from 0 to 100. The higher the score, the higher the perceived quality of the experience. The total score was the sum of the scores of the six dimensions reduced to 100.
  • Measurement of the Postoperative Quality of Recovery (QoR) [ Time Frame: 10 days ]
    The quality of postoperative functional recovery will be assessed by the QoR-15 questionnaire, which 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 on the QoR-15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).
  • Measurement of anxiety level by using a visual analogue scale [ Time Frame: 7 days ]
    It's a visual scale from 0 (no anxiety) to 100 (highest anxiety)
  • Measurement of wake-up quality by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (best wake-up) to 100 (worst wake-up)
  • Measurement of post-operative pain by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no pain) to 100 (highest pain)
  • Measurement of post-operative fatigue by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no fatigue) to 100 (highest fatigue)
  • Measurement of comfort and satisfaction with care by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (ideal care) to 100 worst care)
  • Number of patients taking anesthetic drugs at induction of anaesthesia [ Time Frame: 1 day ]
  • Number of patients taking anesthetic drugs during the post-interventional monitoring [ Time Frame: 1 day ]
  • Number of patients taking morphine in recovery room [ Time Frame: 1 day ]
  • Number of patients taking setrons (nausea and vomiting medication) [ Time Frame: 1 day ]
  • Rate of patients that consider continuing the program of cardiac coherence [ Time Frame: 1 day ]
  • Rate of patients willing to recommend the technique [ Time Frame: 1 day ]
  • Number of days of hospitalization [ Time Frame: 1 month ]
  • Number of patients taking morphine in peroperative [ Time Frame: 1 day ]
  • Measurement of pain at inclusion by using a visual analogue scale [ Time Frame: 1 day ]
    It's a visual scale from 0 (no pain) to 100 (highest pain)
  • The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal. [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) [ Time Frame: 24 hours ]
    The anxiety scale consists of six items, each of which could be scored from 1 to 5 with the end poles "not at all" (1) and "extremely" (5). The score of the anxiety scale is the sum of these four questions, with a scoring range from 6 to 30.
  • Anxiety and depression measure by using Hospital Anxiety Depression Scale (HADS) [ Time Frame: 48 hours ]
    Scores of the HAD scale can be defined as: By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. The minimal score is 0 and the maximal total score is 42.
  • Anxiety by using the visual analogue scale [ Time Frame: 24 hours ]
    Visual analogue scale is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of pain and the position on the right an unbearable pain
  • The Quality of Life by using the EuroQol five dimension (EQ-5D) questionnaire [ Time Frame: 15 days ]
    EuroQol five dimension (EQ-5D) is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems=1/some or moderate problems=2/extreme problems=3)
  • Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G) [ Time Frame: 48 hours ]
    The validated 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 (average of all scores). For each of the scores: the higher the score, the higher the satisfaction. For each dimension, scores were reduced on a scale from 0 to 100. The higher the score, the higher the perceived quality of the experience. The total score was the sum of the scores of the six dimensions reduced to 100.
  • Patient's satisfaction with perioperative period by using scale of Likert [ Time Frame: 48 hours ]
    It's a 10-item scale from 0 to 10
  • Proportion of patients giving their consent to participate in the study among eligible patients at screening [ Time Frame: 6 months ]
  • Quality of life by using the quality of life questionnaire core (QLQ-C30) [ Time Frame: 30 days ]
    The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
  • Measurement of the Postoperative Quality of Recovery (QoR) [ Time Frame: 15 days ]
    The quality of postoperative functional recovery will be assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session
Official Title  ICMJE Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery
Brief Summary the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.
Detailed Description

The perioperative period is recognized as an anxiety-provoking period for patients. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention, fearing not to wake up, to remain in a coma. Consideration of this aspect is very important for patients who require surgery. It is also a concern for caregivers involved in the care of these patients, including anesthesiologists, surgeons and operating room staff.

For many years, pharmacological premedication, including benzodiazepines, has been the gold standard in the treatment of preoperative anxiety.

This systematic prescription is controversial in populations most exposed to side effects such as the elderly, patients with heart or respiratory diseases.

Surgery also seems to influence the impact of premedication. For example, abdominal surgery and breast surgery are associated with a higher risk of agitation upon awakening.

Mental preparation, based on simple explanations by the anaesthetist, is not enough to reduce patients' anxiety.

A recent study evaluated the perioperative experience of patients receiving or not receiving premedication. It shows that benzodiazepines are associated with cognitive impairment and delayed extubation in the elderly. In addition, it seems to have little effect on patient anxiety when compared to a placebo.

In this context of anxiety, an emotional regulation tool appears particularly relevant. Cardiac coherence" (CC) is a particular state of cardiac variability. This state is correlated with many physiological and psychological variables. It is possible to promote this state through different techniques. One of its practices, "fixed frequency guided breathing", seems relevant both in its principles and in its simplicity of implementation.

This specific respiratory mode permits to rebalance the sympathetic - parasympathetic balance of the autonomic nervous system and reveals a state of calm vigilance. This simple, well-coded respiratory psychophysiological practice is widely used in many applications, such as for the most caricatural ones, the management of difficult situations where stress is a central element such as decision-making among fighter pilots on mission, in national education to improve academic learning (especially among anxious students) and also more generally in stress and anxiety management.

This technique induces a refocusing of emotions by regulating the SNA and therefore a better regulation of the hormones involved in the emotional cascade.

This practice has several advantages:

  • it is psychophysiological (psychocorporeal) and widely described in the scientific literature in several indications
  • it is completely free of charge and immediately accessible to the patient, regardless of time and place
  • it can be used at other anxiety-inducing times (e.g., imaging or biopsy tests)
  • it allows total patient autonomy, offering self-management of anxiety and independence from the presence of a third party
  • it can approach a hypnotic model by focusing and absorbing what it can induce on breathing, and thus share some of its benefits
  • It does not have any adverse effects. The major difficulty of this technique is the adherence and regularity of the practice. The optimal effect is dependent on regular training.

To improve this adherence, an audio tape will be put online, read in a hypnotic tone, which will aim to explain respiratory physiology, the benefits of oxygenation on cells and metabolism; this will have the effect of understanding the interest and utility of this exercise and will contribute to induce a feeling of relaxation and well-being.

This study will be a study of feasibility about a program based on the cardiac coherence technique in a context of perioperative anxiety.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Gynecologic Cancer
Intervention  ICMJE Other: Cardiac coherence

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.

Study Arms  ICMJE Experimental: Cardiac coherence
Intervention: Other: Cardiac coherence
Publications *
  • 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.
  • 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):1525-32, table of contents.
  • Muñoz 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.
  • Lepousé 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. Epub 2006 May 2.
  • 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. Erratum in: Am J Cardiol 1996 Feb 1;77(4):330.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
53
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
50
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients undergoing outpatient surgery for their cancer will not be included
  2. Natural bradycardia (50 beats per minute)
  3. Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem
  4. Cardiac arrhythmias
  5. Severe heart failure with ventricular ejection fraction < 40%
  6. Uncontrolled chronic pain
  7. Patients whose medical or psychological conditions do not allow them to complete the study or sign the consent
  8. Patient does not understand the French language
  9. Deaf and/or dumb patient
  10. Adult patient under guardianship or curatorship
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Pierre BLEUSE, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981731
Other Study ID Numbers  ICMJE PROICM 2019-06 COH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jibba AMRAOUI, MD Institut régional du cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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