이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

종양 수술에서 수술 전 불안에 대한 의료 최면과 관련된 심장 일관성 평가 (COHEC2)

2026년 11월 5일 업데이트: Institut du Cancer de Montpellier - Val d'Aurelle

종양 수술의 수술 전 불안에 대한 의학적 최면과 관련된 고정 주파수 유도 호흡(Cardiac Coherence)에 의한 비약물 중재(NDI) 프로그램 평가 3상 연구

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

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

332

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).

간섭 없음: Control group

Classic management of the preoperative period

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Visual Analogue Scale (VAS) of global anxiety
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Program compliance
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 6월 1일

기본 완료 (실제)

2026년 7월 30일

연구 완료 (실제)

2026년 9월 30일

연구 등록 날짜

최초 제출

2021년 12월 8일

QC 기준을 충족하는 최초 제출

2022년 1월 14일

처음 게시됨 (실제)

2022년 1월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다