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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy; Surgery, Digestive System
• Intervention / Treatment: Procedure: Hypnoanalgesia

Detailed Description

The use of medical hypnosis has been developing for about fifteen years in several health facilities.

The Hospital Group Paris Saint-Joseph has progressively introduced first this technique from 2007 to the operating room and in the various services of conventional and ambulatory hospitalizations.

The French Society of Anesthesia and Intensive Care (SFAR) recognizes the hypnosedation as sedation technique that can be used in acute pain and anesthesia (operating theater, emergency, painful treatments ...).

There are currently many quality scientific papers published in international journals in particular by the team of Pr. M. E. Faymonville Liege, who explained the mechanisms and consequences of hypnosedation.

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. It can also complement a regional anesthesia to increase patient comfort (less stress, anxiety and pain) .If necessary, the conversion of general anesthesia hypnosedation is always possible during surgery or gastrointestinal endoscopy.

In the Paris Saint joseph Hospital facility, several anesthesiologists and nurse anesthetists are trained in medical hypnosis. Now, a common practice in surgery hypnosedation (inguinal hernia, thyroid and para-thyroid surgery) and endoscopy (colonoscopy, gastroesophageal gastroduodenal endoscopy) .On a period of 3 years, 414 acts were carried out under hypnosedation. When digestive endoscopy adding sedation is not systematic and, if the patient is comfortable enough without conscious sedation, only hypnoanalgesia is used (use of hypnosis in the prevention or relief of acute pain or chronic).

This technique is part of the panel modes of analgesia and anesthesia can be offered to patients. However, little is known about patient satisfaction and their experiences during the procedure under hypnosedation.

The objective is to evaluate these parameters on a prospective cohort of patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or surgery.

This evaluation is part of the evaluation of professional practices (EPP) recommended by the HAS (french High Authority of Health) and the ARS (Regional Health Agency).

Main objective / secondary

Primary objective :

Measure satisfaction of patients resorted to hypnosedation or hypnoanalgesia during an endoscopy or surgery

Secondary objective:

Measure the doses of drugs used for conscious sedation

Methodology :

• DESIGN: Prospective cohort single-center, non-interventional kind EPP on the satisfaction of patients who underwent hypnosedation for surgery or endoscopy
• Duration of the study: 8 months (November 2015-June 2016): the estimated number of 80 patients
• Acquisition of data:
• Age, weight, height, gender, ASA (Physical status score) score
• Type of surgery or endoscopy
• Previous history of surgery or endoscopy
• Names and doses of treatments
• Conversion to general anesthesia yes / no
• Length of management in operating room
• Adverse events during surgery and in recovery
• Evaluation using a numerical scale from 0 to 10:
• Patient anxiety during the pre- and per-interventional
• The per-Interventional Pain, Interventional immediate post-and before the release of the SSPI (The post-interventional surveillance room)
• The feeling of active participation in the intervention
• The quality of the relationship with the hypnotist during surgery
• Overall satisfaction during surgery
• Acceptance or not the patient to repeat surgery or examination under the same terms
• Acceptance or not to recommend the patient to the relatives hypnosedation
• Case open for any comments or suggestions obviousness

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	Pain: An average value: <3: low or no pain; From 3 to 5.9: moderate pain •> 5.9: strong pain	Day 1 within the first hour after Hypnoanalgesia or Hypnosedation
Anxiety assessment	An average value: <3: low or absent anxiety; From 3 to 5.9: moderate anxiety •> 5.9: high anxiety	Day 1 within the first hour after Hypnoanalgesia or Hypnosedation

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: GORY Christian, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2016
• Primary Completion (Actual): November 2, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SEDuCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No