Clinical trial NCT02505880: Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests
Official title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Invasive Surgery
Keywords: Hypnosis
Pediatric surgery
Anesthesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Time to "home readiness"
timeFrame: up to 4 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: up to 10 minutes after the entrance to recovery room
measure: Score Induction Compliance Checklist (ICC)
timeFrame: up to 10 minutes after the entrance to recovery room
measure: Analgesic consumption
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Chrystelle CS Sola, MD
role: PRINCIPAL_INVESTIGATOR
References: