Colorectal Cancer Screnning Colonoscopy Under Hypnosis
ConditionColorectal (Colon or Rectal) Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Tours
About this trial
Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age or older
Undergoing a screening colonoscopy (mass screening Fecal Immunochemical Test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia
Affiliated with a French social security system
Having signed a written consent
Disqualifiers
Patient requiring emergency colonoscopy
History of colonic resection
Carriers of behavioral disorders and/or psychiatric illness
Limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems)
Trial design
Design model
Parallel
Treatments tested in this trial
Colonoscopy under hypnosis
Procedure/SurgeryThe hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: HypnosisExperimental treatment 1 intervention
Group B: General anesthesiaNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of complete colonoscopies
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, from the start to the end of the colonoscopySecondary outcomes
1
Level of anxiety
Level of anxiety is measured by the State-Trait Anxiety Inventory (Form Y) scale
Time frame
The day of the colonoscopy, before the exam2
Level of pain
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
During the consultation before the colonoscopy3
Level of pain
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 colonoscopy4
Duration of colonoscopy
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 examSponsors and contacts
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Source ClinicalTrials.gov