NCT05051046

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress71%
Jan 2022Feb 2028

First Submitted

Initial submission to the registry

July 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2028

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

6 years

First QC Date

July 20, 2021

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

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.

    The day of the colonoscopy, from the start to the end of the colonoscopy

Secondary Outcomes (8)

  • Level of anxiety

    The day of the colonoscopy, before the exam

  • Level of pain

    During the consultation before the colonoscopy

  • Level of pain

    Up to 24 hours the day of colonoscopy

  • Duration of colonoscopy

    The day of colonoscopy from the start to the end of the exam

  • Rate of polyps resected

    The day of colonoscopy from the start to the end of the exam

  • +3 more secondary outcomes

Study Arms (2)

Hypnosis

EXPERIMENTAL
Procedure: Colonoscopy under hypnosis

General anesthesia

NO INTERVENTION

Common practice

Interventions

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

Hypnosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Angers

Angers, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Driffa MOUSSATA, PhD

    University Hospital Center of Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

September 21, 2021

Study Start

January 31, 2022

Primary Completion (Estimated)

February 7, 2028

Study Completion (Estimated)

February 7, 2028

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations