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EndoscopySEDuCENCT02834091

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

An observational study of Endoscopy and Surgery, Digestive System, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endoscopy, Surgery, Digestive System
What is being tested?
Hypnoanalgesia
Type of treatment
Surgery or procedure
How many people
80 participants
Where
1 siteFrance
Study dates
22 Jan 2016to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients who used the hypnosedation or hypnoanalgesia during an endoscopy or surgery

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

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.

Read the 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
Being tested
Hypnoanalgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnoanalgesiaProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 1 After Hypnoanalgesia or Hypnosedation

Secondary outcomes (2)
  1. Pain Assessment

    Pain:

    An average value:

    • <3: low or no pain
    • From 3 to 5.9: moderate pain •> 5.9: strong pain

    Measured: Day 1 within the first hour after Hypnoanalgesia or Hypnosedation

  2. Anxiety assessment

    An average value:

    • <3: low or absent anxiety
    • From 3 to 5.9: moderate anxiety •> 5.9: high anxiety

    Measured: Day 1 within the first hour after Hypnoanalgesia or Hypnosedation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2016 (estimated)
  2. Study start22 Jan 2016
  3. Primary completion2 Nov 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02834091
Sponsor's protocol ID
SEDuCE
Acronym
SEDuCE
Status last verified
Sep 2017
First submitted
30 Jun 2016
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endoscopy and Surgery, Digestive System, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Patient satisfaction (time frame: Day 1 After Hypnoanalgesia or Hypnosedation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

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