Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 5
- 主要终点
- Visual Analogue Scale (VAS) of global anxiety
研究概览
简要总结
The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization
- •Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone
- •Patient with a smartphone or a tablet or a computer and able to install the application
- •Inclusion of the patient minimum 7 days before the date of the surgery
- •Patient who signed the informed consent
- •Patient affiliated to a French social security system
排除标准
- •Emergency surgery
- •Plastic surgery for reconstruction: lipomodelling
- •Prophylactic surgery: no suspected or existing cancer
- •Bradycardia (< 50 beats/minute) with β-blockers
- •Severe heart failure with ventricular ejection fraction < 40%
- •Uncontrolled chronic pain for more than three months on morphine
- •Patient with unstable epilepsy or respiratory pathology with rest dyspnea
- •Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ...
- •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)
- •Deaf patient without hearing aids
- •Patient under guardianship or curatorship
结局指标
主要结局
Visual Analogue Scale (VAS) of global anxiety
时间窗: 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).
次要结局
- Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)(Between -15 to -7 days before surgery (Day -15 to Day -7))
- Doses of hypnotic and morphine drugs(During anesthetic induction (Day 0))
- Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)(Two day after surgery (Day 2))
- Visual Analogue Scale (VAS) of pain(At 1, 2 and 3 month after surgery)
- Quality of Recovery (QoR)(The day after surgery (Day 1))
- Insomnia Severity Index Scale (ISI)(The day after surgery (Day 1))
- VAS of on satisfaction with overall management and anesthesia(The day after surgery (Day 1))
- Value of preoperative VAS and adverse events(The morning of the surgery (Day 0) upon arrival in the operating room)
- Number of Self-questionnaire completed(From the day of the anesthesia consultation until the end of the study)
- Program compliance(Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0))
- Number of patients taking benzodiazepine(The day after surgery (Day 1))
- Measurement of global anxiety level by using a Visual Analogue Scale (VAS)(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)(Between -15 to -7 days before surgery)
- VAS values and individual psycho-clinical characteristics(Between -15 to -7 days before surgery and the day of surgery (Day 0))
- Number of days of hospitalization(The day after surgery (Day -1) and up to 1 month)
- VAS values and mode of hospitalization and importance of the surgical procedure(The morning of the surgery (Day 0) upon arrival in the operating room)