Colonoscopy for colorectal cancer screening using hypnosis
Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
This study tests if using hypnosis instead of general anesthesia during colonoscopy can help people feel less anxious and uncomfortable while getting screened for colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Angers) |
| Trial ID | NCT05051046 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hypnosis as an alternative to general anesthesia during colonoscopy for colorectal cancer screening. Colorectal cancer is a prevalent condition, and colonoscopy is a critical screening tool that is often performed under general anesthesia due to patient discomfort. The study aims to determine if hypnosis can reduce anxiety and pain, making the procedure more acceptable to patients while also minimizing the risks and costs associated with general anesthesia. By assessing patient tolerance and outcomes, the study seeks to provide a viable option for those undergoing screening.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing a screening colonoscopy and are affiliated with the French social security system.
Not a fit: Patients requiring emergency colonoscopy or those with contraindications to hypnosis or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more cost-effective colorectal cancer screenings for patients.
How similar studies have performed: While hypnosis has been tested in various contexts, most studies have been small and non-randomized, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers
- Chu Angers — Angers, France (Recruiting)
Study contacts
- Principal investigator: Driffa MOUSSATA, PhD — University Hospital Center of Tours
- Study coordinator: Driffa MOUSSATA, PhD
- Email: D.MOUSSATA@chu-tours.fr
- Phone: +33 2 47 47 83 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.