Inflammatory Bowel DiseasesHYSTERIANCT03261414
HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia
A study testing Hypnosis in people with Inflammatory Bowel Diseases and Anesthesia, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Anesthesia
- What is being tested?
- Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to 30 Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy
- Never been operated for abdominal crohn's disease
Who cannot join
- Pregnant women
- A history of intestinal resection for crohn's disease
- Emergency surgery
- Corticotherapy in progress
- Deaf patients
- non-Francophone Patients
- Patients with knowledge of self-hypnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.
The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease
- Conditions
- Inflammatory Bowel Diseases, Anesthesia
- Being tested
- Hypnosis, usual care
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisProcedure or surgery
A short preanesthetic hypnosis before induction of anesthesia
usual careProcedure or surgery
Standard care before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| With preoperative hypnosis | Experimental | standard care plus hypnosis followed by administration of propofol for anesthesia induction Receives: Procedure: Hypnosis |
| Without preoperative hypnosis | Active comparator | standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction Receives: Procedure: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
Measured: During the first 24 postoperative hours
Secondary outcomes (7)
Total morphine consumption
Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record
Measured: between the 24 and the 48 postoperative hours
Total number of patients with complications
Measured: during first 7 postoperative days
Intraoperative consumption of hypnotics and opioids
The hypnotics and opioids drug dose will be recorded
Measured: during first 7 postoperative days
Antiemetics consumption
The antiemetic drug dose will be recorded
Measured: during first 7 postoperative days
Postoperative nausea and vomiting (PONV) Score
PONV risk assessment tool Based on apfel's simplified risk score
Measured: first 24 postoperative hours
Duration of hospital stay
Measured: during first 7 postoperative days
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Measured: during first 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start27 May 2015
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Zerbib, MD,PhD, Principal investigator, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261414
- Sponsor's protocol ID
- 2013_54
- Other IDs
- 2014-A00622-45
- Acronym
- HYSTERIA
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.
- ClinicalTrials.gov ID
- NCT03261414
- Acronym / sponsor ID
- HYSTERIA / 2013_54
- Conditions
- Inflammatory Bowel Diseases, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 25 Aug 2017 (actual)
- 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 aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With preoperative hypnosis | Experimental | Procedure: Hypnosisstandard care plus hypnosis followed by administration of propofol for anesthesia induction |
| Without preoperative hypnosis | Active comparator | Procedure: usual carestandard care without preoperative hypnosis followed by administration of propofol for anesthesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy
- Never been operated for abdominal crohn's disease
Key exclusion criteria (7 listed)
- Pregnant women
- A history of intestinal resection for crohn's disease
- Emergency surgery
- Corticotherapy in progress
- Deaf patients
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 |
|---|---|---|
| HypnosisA short preanesthetic hypnosis before induction of anesthesia | Procedure or surgery | With preoperative hypnosis |
| usual careStandard care before induction of anesthesia | Procedure or surgery | Without preoperative hypnosis |
Primary outcome
Total morphine consumption
Time frame: During the first 24 postoperative hours
Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
7 secondary outcomes
Total morphine consumption
Time frame: between the 24 and the 48 postoperative hours
Total number of patients with complications
Time frame: during first 7 postoperative days
Intraoperative consumption of hypnotics and opioids
Time frame: during first 7 postoperative days
Antiemetics consumption
Time frame: during first 7 postoperative days
Postoperative nausea and vomiting (PONV) Score
Time frame: first 24 postoperative hours
Duration of hospital stay
Time frame: during first 7 postoperative days
Time physiological function recovery
Time frame: during first 7 postoperative days
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 9 Mar 2021.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
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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.
Philippe Zerbib, MD,PhD principal investigator
University Hospital of Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Inflammatory Bowel Diseases and Anesthesia, run by University Hospital, Lille 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 2 inclusion and 7 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 9 Mar 2021. 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?
Total morphine consumption (time frame: During the first 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261414, which also lists 1 linked publication.
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 9 Mar 2021.