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HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia (HYSTERIA)

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ClinicalTrials.gov Identifier: NCT03261414
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Anesthesia Procedure: Hypnosis Procedure: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: With preoperative hypnosis
standard care plus hypnosis followed by administration of propofol for anesthesia induction
Procedure: Hypnosis
A short preanesthetic hypnosis before induction of anesthesia

Active Comparator: Without preoperative hypnosis
standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
Procedure: usual care
Standard care before induction of anesthesia




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Total morphine consumption [ Time Frame: between the 24 and the 48 postoperative hours ]
    Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record

  2. Total number of patients with complications [ Time Frame: during first 7 postoperative days ]
  3. Intraoperative consumption of hypnotics and opioids [ Time Frame: during first 7 postoperative days ]
    The hypnotics and opioids drug dose will be recorded

  4. Antiemetics consumption [ Time Frame: during first 7 postoperative days ]
    The antiemetic drug dose will be recorded

  5. Postoperative nausea and vomiting (PONV) Score [ Time Frame: first 24 postoperative hours ]
    PONV risk assessment tool Based on apfel's simplified risk score

  6. Duration of hospital stay [ Time Frame: during first 7 postoperative days ]
  7. Time physiological function recovery [ Time Frame: during first 7 postoperative days ]
    Ability to drink, to eat, to urinate, to walk



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261414


Locations
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France
Hôpital Claude Huriez
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Philippe Zerbib, MD,PhD University Hospital of Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03261414    
Other Study ID Numbers: 2013_54
2014-A00622-45 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases