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

March 8, 2021 updated by: University Hospital, Lille

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between the 24 and the 48 postoperative hours
Total number of patients with complications
Time Frame: during first 7 postoperative days
during first 7 postoperative days
Intraoperative consumption of hypnotics and opioids
Time Frame: during first 7 postoperative days
The hypnotics and opioids drug dose will be recorded
during first 7 postoperative days
Antiemetics consumption
Time Frame: during first 7 postoperative days
The antiemetic drug dose will be recorded
during first 7 postoperative days
Postoperative nausea and vomiting (PONV) Score
Time Frame: first 24 postoperative hours
PONV risk assessment tool Based on apfel's simplified risk score
first 24 postoperative hours
Duration of hospital stay
Time Frame: during first 7 postoperative days
during first 7 postoperative days
Time physiological function recovery
Time Frame: during first 7 postoperative days
Ability to drink, to eat, to urinate, to walk
during first 7 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Philippe Zerbib, MD,PhD, University Hospital of Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 27, 2015

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_54
  • 2014-A00622-45 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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