HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia
HYSTERIA
Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.
2 other identifiers
interventional
77
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2015
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedMarch 9, 2021
March 1, 2021
4.7 years
July 31, 2017
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Total morphine consumption
Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
During the first 24 postoperative hours
Secondary Outcomes (7)
Total morphine consumption
between the 24 and the 48 postoperative hours
Total number of patients with complications
during first 7 postoperative days
Intraoperative consumption of hypnotics and opioids
during first 7 postoperative days
Antiemetics consumption
during first 7 postoperative days
Postoperative nausea and vomiting (PONV) Score
first 24 postoperative hours
- +2 more secondary outcomes
Study Arms (2)
With preoperative hypnosis
EXPERIMENTALstandard care plus hypnosis followed by administration of propofol for anesthesia induction
Without preoperative hypnosis
ACTIVE COMPARATORstandard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
Interventions
A short preanesthetic hypnosis before induction of anesthesia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Claude Huriez
Lille, France
Related Publications (1)
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.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Zerbib, MD,PhD
University Hospital of Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 25, 2017
Study Start
May 27, 2015
Primary Completion
January 30, 2020
Study Completion
January 30, 2020
Last Updated
March 9, 2021
Record last verified: 2021-03