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Ocena koherencji serca związanej z hipnozą medyczną w kontekście lęku przedoperacyjnego w chirurgii onkologicznej (COHEC2)

5 listopada 2026 zaktualizowane przez: Institut du Cancer de Montpellier - Val d'Aurelle

Badanie fazy III oceniające program interwencji nielekowej (NDI) za pomocą oddychania kierowanego o stałej częstotliwości (koherencja serca) w połączeniu z hipnozą medyczną w zakresie lęku przedoperacyjnego w chirurgii onkologicznej

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

Przegląd badań

Status

Zakończony

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

332

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Lyon, Francja
        • Centre Léon Bérard
      • Toulouse, Francja
        • Institut Universitaire du Cancer Toulouse - Oncopole
      • Villejuif, Francja
        • Institut Gustave Roussy
    • Hérault
      • Montpellier, Hérault, Francja, 34298
        • Institut régional du cancer de Montpellier

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental group

Classic management of the preoperative period with a 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).

Brak interwencji: Control group

Classic management of the preoperative period

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Visual Analogue Scale (VAS) of global anxiety
Ramy czasowe: 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).

The morning of the surgery (Day 0) upon arrival in the operating room

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Program compliance
Ramy czasowe: 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).

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)
Ramy czasowe: 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

Between -15 to -7 days before surgery (Day -15 to Day -7)
Measurement of global anxiety level by using a Visual Analogue Scale (VAS)
Ramy czasowe: 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).

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)
Ramy czasowe: 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

Between -15 to -7 days before surgery
VAS values and individual psycho-clinical characteristics
Ramy czasowe: 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).

Between -15 to -7 days before surgery and the day of surgery (Day 0)
Number of patients taking benzodiazepine
Ramy czasowe: The day after surgery (Day 1)

Rate of patients taking benzodiazepines in the 2 groups

The day after surgery (Day 1)
Number of days of hospitalization
Ramy czasowe: The day after surgery (Day -1) and up to 1 month

Length of hospital stay in the 2 groups

The day after surgery (Day -1) and up to 1 month
VAS values and mode of hospitalization and importance of the surgical procedure
Ramy czasowe: 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)

The morning of the surgery (Day 0) upon arrival in the operating room
Doses of hypnotic and morphine drugs
Ramy czasowe: During anesthetic induction (Day 0)

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

During anesthetic induction (Day 0)
Value of preoperative VAS and adverse events
Ramy czasowe: 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), ...

The morning of the surgery (Day 0) upon arrival in the operating room
Number of Self-questionnaire completed
Ramy czasowe: 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

From the day of the anesthesia consultation until the end of the study
Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)
Ramy czasowe: 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.

Two day after surgery (Day 2)
Visual Analogue Scale (VAS) of pain
Ramy czasowe: 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

At 1, 2 and 3 month after surgery
Quality of Recovery (QoR)
Ramy czasowe: 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).

The day after surgery (Day 1)
Insomnia Severity Index Scale (ISI)
Ramy czasowe: 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).

The day after surgery (Day 1)
VAS of on satisfaction with overall management and anesthesia
Ramy czasowe: 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)

The day after surgery (Day 1)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Régis FUZIER, MD, Institut Universitaire du Cancer Toulouse - Oncopole
  • Główny śledczy: Lauriane Bordevane, MD, Gustave Roussy, Cancer Campus, Grand Paris
  • Krzesło do nauki: Jibba AMRAOUI, MD, Institut régional du cancer de Montpellier

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2022

Zakończenie podstawowe (Rzeczywisty)

30 lipca 2026

Ukończenie studiów (Rzeczywisty)

30 września 2026

Daty rejestracji na studia

Pierwszy przesłany

8 grudnia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 stycznia 2022

Pierwszy wysłany (Rzeczywisty)

20 stycznia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • PROICM 2021-09 COH
  • 2021-A01524-37 (Identyfikator rejestru: ID RCB)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Ramy czasowe udostępniania IPD

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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