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Vurdering av hjertekoherens assosiert med medisinsk hypnose på preoperativ angst i onkologisk kirurgi (COHEC2)

Fase III-studie som evaluerer et ikke-medikamentell intervensjonsprogram (NDI) etter guidet pusting med fast frekvens (hjertekoherens) assosiert med medisinsk hypnose på preoperativ angst i onkologisk kirurgi

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

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

332

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).

Ingen inngripen: Control group

Classic management of the preoperative period

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Analogue Scale (VAS) of global anxiety
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Program compliance
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2022

Primær fullføring (Faktiske)

30. juli 2026

Studiet fullført (Faktiske)

30. september 2026

Datoer for studieregistrering

Først innsendt

8. desember 2021

Først innsendt som oppfylte QC-kriteriene

14. januar 2022

Først lagt ut (Faktiske)

20. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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