Colorectal Cancer Screnning Colonoscopy Under Hypnosis

NCT ID: NCT05051046

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2028-02-07

Brief Summary

Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated

Detailed Description

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.

Conditions

Colorectal (Colon or Rectal) Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hypnosis

Group Type: EXPERIMENTAL

Colonoscopy under hypnosis

Intervention Type: PROCEDURE

The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.

General anesthesia

Common practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colonoscopy under hypnosis

The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment)
• Contraindication to general anesthesia
• Under a legal protection regime
• Pregnant or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Driffa MOUSSATA, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Tours

Locations

Chu Angers

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Driffa MOUSSATA, PhD

Role: CONTACT

D.MOUSSATA@chu-tours.fr

+33 2 47 47 83 50

Elodie MOUSSET

Role: CONTACT

e.mousset@chu-tours.fr

+33 2 47 47 46 65

Facility Contacts

Elodie METIVIER

Role: primary

Elmetiviercesbron@chu-angers.fr

Other Identifiers

DR200072

Identifier Type: -

Identifier Source: org_study_id