| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Gynecologic Cancer | Other: Cardiac coherence | Not Applicable |
Show detailed description
| 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 |
| 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. |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Jean-Pierre BLEUSE, MD | 4 67 61 31 02 ext +33 | jean-pierre.bleuse@icm.unicancer.fr |
| 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 | |
| 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 |
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.
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| Original Primary Outcome Measures ICMJE |
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.
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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:
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. |
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| 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 |
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| Condition ICMJE |
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| 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. |
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| Study Arms ICMJE | Experimental: Cardiac coherence
Intervention: Other: Cardiac coherence
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
53 | ||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| 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 |
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| PRS Account | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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