Chu Angers
Angers, France
Location status: Recruiting
NCT Number: NCT05051046
Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Angers, France
Location status: Recruiting
Colorectal cancer is the 3rd most common cancer. Colonoscopy, a screening examination, has led to an increase in patient survival. In more than 90% of cases, this examination is performed under general anesthesia (GA) because it is considered painful, even though several studies have shown its feasibility without GA with a good tolerance in 75% of cases. However, only 28% of patients accept the examination without GA because of great apprehension. GA entails an increased risk of complications but also additional costs. Thus, performing colonoscopies without GA would reduce risks and costs by 15 to 30%. In order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. To date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized.
The use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to GA and reduce the organizational constraints and costs related to GA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
Time frame: The day of the colonoscopy, from the start to the end of the colonoscopy
Rate of complete colonoscopies: a colonoscopy is said to be complete when the endoscopist visualizes the caecal fundus.
Time frame: The day of the colonoscopy, before the exam
Level of anxiety is measured by the State-Trait Anxiety Inventory (Form Y) scale
Time frame: During the consultation before the colonoscopy
pain level measured by self-evaluation via a visual analog scale between 0 and 10 cm, at the consultation, before and after the colonoscopy in both groups and during the procedure, before returning to the room only in the Hypnosis group. The doctor will present the ungraded side of the VAS to the patient and ask him/her to place the cursor on the maximum pain intensity felt during the procedure.
Time frame: Up to 24 hours the day of colonoscopy
pain level measured by self-evaluation via a visual analog scale between 0 and 10 cm, at the consultation, before and after the colonoscopy in both groups and during the procedure, before returning to the room only in the Hypnosis group. The doctor will present the ungraded side of the VAS to the patient and ask him/her to place the cursor on the maximum pain intensity felt during the procedure.
Time frame: The day of colonoscopy from the start to the end of the exam
Duration of the endoscopy measured in minutes, distinguishing between: the time between the introduction of the endoscope into the anus and its arrival at the caecal floor and the time required in the opposite direction. The time taken to remove the polyps will be counted.
Time frame: The day of colonoscopy from the start to the end of the exam
compare the rate of resected polyps between the two groups
Time frame: To the day of the exam to 8 days after
Rate of complications within 8 days post-colonoscopy (perforation, bleeding, inhalation pneumonitis, ...). Patients will be instructed to call back the service in case of complications
Time frame: Up to 24 hours the day of the colonoscopy
Patient satisfaction questionnaire regarding the different stages of their care as well as their future wishes regarding the procedure to be considered in the event of a new colonoscopy. The satisfaction questionnaire will focus on the patient's experience of the management on arrival, the set-up in the examination room and the procedure. The best way to verify patient satisfaction is to ask the patient if he or she would like the next colonoscopy to be done under the same conditions.
Time frame: To the day of the exam to 3 months after
Proportion of pairs (Δ cost, Δ effect) belonging to the non-inferiority area in the incremental cost-effectiveness design, for different values of the economic non-inferiority margin and at constant value of the clinical non-inferiority margin (5%).
Contact information is provided by the study sponsor or research team.
Driffa MOUSSATA, PhD
CONTACT
Elodie MOUSSET
CONTACT
University Hospital, Tours
Other
Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
Acronym: CODEPICCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07321106
Advanced Colorectal Cancer, CRC
Duarte, California, United States
View Trial DetailsNCT07529808
Adenocarcinoma, Advanced Gastric Cancer
Fairfax, Virginia, United States
View Trial DetailsNCT07675967
Adenocarcinoma Of Esophagus, Bone Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07419490
Colonic Diseases, Colonic Neoplasms
Tampa, Florida, United States
View Trial Details