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.
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
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
- Conditions
- Endoscopy, Surgery, Digestive System
- 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.
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)
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
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.
- First posted15 Jul 2016 (estimated)
- Study start22 Jan 2016
- Primary completion2 Nov 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GORY Christian, Principal investigator, Fondation Hôpital Saint-Joseph
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Survey of Patients Over Hypnoanalgesia or Hypnosedation at a Digestive Endoscopy or Surgery
- ClinicalTrials.gov ID
- NCT02834091
- Acronym / sponsor ID
- SEDuCE / SEDuCE
- Conditions
- Endoscopy, Surgery, Digestive System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 2 Nov 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who used the hypnosedation or hypnoanalgesia during an endoscopy or surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnoanalgesia | Procedure or surgery | – |
Primary outcome
Assessment of Patient satisfaction
Time frame: Day 1 After Hypnoanalgesia or Hypnosedation
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
2 secondary outcomes
Pain Assessment
Time frame: Day 1 within the first hour after Hypnoanalgesia or Hypnosedation
Anxiety assessment
Time frame: Day 1 within the first hour after Hypnoanalgesia or Hypnosedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GORY Christian principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
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.