HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia (HYSTERIA)
Primary Purpose
Inflammatory Bowel Diseases, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis
usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
Eligibility 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
Sites / Locations
- Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
With preoperative hypnosis
Without preoperative hypnosis
Arm Description
standard care plus hypnosis followed by administration of propofol for anesthesia induction
standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
Outcomes
Primary Outcome Measures
Total morphine consumption
Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
Secondary Outcome Measures
Total morphine consumption
Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record
Total number of patients with complications
Intraoperative consumption of hypnotics and opioids
The hypnotics and opioids drug dose will be recorded
Antiemetics consumption
The antiemetic drug dose will be recorded
Postoperative nausea and vomiting (PONV) Score
PONV risk assessment tool Based on apfel's simplified risk score
Duration of hospital stay
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Full Information
NCT ID
NCT03261414
First Posted
July 31, 2017
Last Updated
March 8, 2021
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03261414
Brief Title
HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia
Acronym
HYSTERIA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With preoperative hypnosis
Arm Type
Experimental
Arm Description
standard care plus hypnosis followed by administration of propofol for anesthesia induction
Arm Title
Without preoperative hypnosis
Arm Type
Active Comparator
Arm Description
standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
Intervention Type
Procedure
Intervention Name(s)
Hypnosis
Intervention Description
A short preanesthetic hypnosis before induction of anesthesia
Intervention Type
Procedure
Intervention Name(s)
usual care
Intervention Description
Standard care before induction of anesthesia
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
Time Frame
During the first 24 postoperative hours
Secondary Outcome Measure Information:
Title
Total morphine consumption
Description
Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record
Time Frame
between the 24 and the 48 postoperative hours
Title
Total number of patients with complications
Time Frame
during first 7 postoperative days
Title
Intraoperative consumption of hypnotics and opioids
Description
The hypnotics and opioids drug dose will be recorded
Time Frame
during first 7 postoperative days
Title
Antiemetics consumption
Description
The antiemetic drug dose will be recorded
Time Frame
during first 7 postoperative days
Title
Postoperative nausea and vomiting (PONV) Score
Description
PONV risk assessment tool Based on apfel's simplified risk score
Time Frame
first 24 postoperative hours
Title
Duration of hospital stay
Time Frame
during first 7 postoperative days
Title
Time physiological function recovery
Description
Ability to drink, to eat, to urinate, to walk
Time Frame
during first 7 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Zerbib, MD,PhD
Organizational Affiliation
University Hospital of Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez
City
Lille
Country
France
12. IPD Sharing Statement
Learn more about this trial
HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia
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