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临床试验/NCT02505880
NCT02505880已完成不适用

Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Time to "home readiness"

研究概览

简要总结

In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).

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
Single (Care Provider)

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient hospitalized in infantile ambulatory surgery unit
  • Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III
  • Patient among whom the parents or the legal guardian gave their informed consent
  • Patient member in a national insurance scheme

排除标准

  • Patient presenting a contraindication to general anesthesia
  • Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)

研究组 & 干预措施

1: General anesthesia

Active Comparator

General anesthesia

干预措施: General anesthesia (Drug)

2: Hypnosis

Experimental

Hypnosis with local anesthesia

干预措施: Local anesthetic + Hypnosis (Other)

结局指标

主要结局

Time to "home readiness"

时间窗: up to 4 days

The time to "home readiness" is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria.

次要结局

  • Score Induction Compliance Checklist (ICC)(up to 10 minutes after the entrance to recovery room)
  • Analgesic consumption(up to 24 hours after surgery)
  • Postoperative pain(up to 10 minutes after the entrance to recovery room)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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