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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Proportion of patients who have enrolled in the pre-habilitation program
研究概览
简要总结
the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Surgery for breast or gynaecological cancer requiring scheduled hospitalization for up to 3 days
- •Signing of informed consent before any specific procedure in the study
- •Patient affiliated to a social security system
排除标准
- •Patients undergoing outpatient surgery for their cancer will not be included
- •Natural bradycardia (50 beats per minute)
- •Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem
- •Cardiac arrhythmias
- •Severe heart failure with ventricular ejection fraction < 40%
- •Uncontrolled chronic pain
- •Patients whose medical or psychological conditions do not allow them to complete the study or sign the consent
- •Patient does not understand the French language
- •Deaf and/or dumb patient
- •Adult patient under guardianship or curatorship
研究组 & 干预措施
Cardiac coherence
干预措施: Cardiac coherence (Other)
结局指标
主要结局
Proportion of patients who have enrolled in the pre-habilitation program
时间窗: 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.
次要结局
- Measurement of post-operative pain by using a visual analogue scale(1 day)
- Measurement of post-operative fatigue by using a visual analogue scale(1 day)
- Measurement of comfort and satisfaction with care by using a visual analogue scale(1 day)
- Measurement of anxiety level by using a visual analogue scale(7 days)
- Number of patients taking anesthetic drugs at induction of anaesthesia(1 day)
- Number of patients taking anesthetic drugs during the post-interventional monitoring(1 day)
- Rate of patients willing to recommend the technique(1 day)
- Number of days of hospitalization(1 month)
- Number of patients taking morphine in peroperative(1 day)
- The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal.(1 day)
- The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)(7 days)
- Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G)(48 hours)
- Measurement of the Postoperative Quality of Recovery (QoR)(10 days)
- Measurement of wake-up quality by using a visual analogue scale(1 day)
- Number of patients taking morphine in recovery room(1 day)
- Measurement of pain at inclusion by using a visual analogue scale(1 day)
- Number of patients taking setrons (nausea and vomiting medication)(1 day)
- Rate of patients that consider continuing the program of cardiac coherence(1 day)