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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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 31, 2017
Last Updated
March 8, 2021
Sponsor
University Hospital, Lille
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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

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

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