Satisfaction Survey of Patients Over Hypnoanalgesia or Hypnosedation at a Digestive Endoscopy or Surgery

NCT02834091 | Completed DMC

• 1 other identifier: SEDuCE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The use of hypnosedation in the context of anesthesia is validated. This is a technique that combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with local anesthesia surgical site. It can favorably replace general anesthesia if surgery or endoscopy allows but doctors will always need local anesthesia surgical site where surgery The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to the operating room and in the various services of conventional and ambulatory hospitalizations. The goal of the investigators is to evaluate these parameters on a prospective cohort of patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or surgery.

Conditions

Endoscopy; Surgery, Digestive System

Outcome Measures

Primary Outcomes (1)

• Assessment of Patient satisfaction

  Patient satisfaction rated on a scale from 0 (dissatisfied) to 10 (extremely satisfied). An average value: * \<5: low satisfaction * From 5 to 7.4: Average satisfaction •\> 7.5: Important satisfaction

  Day 1 After Hypnoanalgesia or Hypnosedation

Secondary Outcomes (2)

• Pain Assessment

  Day 1 within the first hour after Hypnoanalgesia or Hypnosedation

• Anxiety assessment

  Day 1 within the first hour after Hypnoanalgesia or Hypnosedation

Interventions

Hypnoanalgesia PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who used the hypnosedation or hypnoanalgesia during an endoscopy or surgery

You may qualify if:

• Patients who chose surgery or endoscopy under hypnosedation
• Selected in consultation surgery or gastroenterology for a realization of the act under hypnosedation.
• Having a pre-hypnosedation anesthesia consultation by an anesthesiologist trained in hypnosis with validation of eligibility for hypnosedation.
• No opposition to participate in the study

You may not qualify if:

• Absence affiliate to a social security scheme
• Patients not eligible for hypnosedation:
• No specific consultation pre-anesthesia hypnosedation
• Poor understanding of the French language
• Major Hearing problems
• Severe cognitive or psychiatric disorders
• Insufficient reasoning or refusal with respect to the use of hypnosedation
• Administration of anxiolytic premedication

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• GORY Christian

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 15, 2016
• Study Start: January 22, 2016
• Primary Completion: November 2, 2016
• Study Completion: June 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)