Colorectal (Colon or Rectal) CancerCODEPICCHNCT05051046
Colorectal Cancer Screnning Colonoscopy Under Hypnosis
A study testing Colonoscopy under hypnosis in people with Colorectal (Colon or Rectal) Cancer, run by University Hospital, Tours at 1 site in France.
Trial summary
Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer
- What is being tested?
- Colonoscopy under hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2022to 7 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Angers
Angers
Elodie METIVIER, Elmetiviercesbron@chu-angers.fr
About this study
Official title: Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated
Read the 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
- Being tested
- Colonoscopy under hypnosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy under hypnosisProcedure or surgery
The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Not described Receives: Procedure: Colonoscopy under hypnosis |
| General anesthesia | No intervention | Common practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete colonoscopies
Rate of complete colonoscopies: a colonoscopy is said to be complete when the endoscopist visualizes the caecal fundus.
Measured: The day of the colonoscopy, from the start to the end of the colonoscopy
Secondary outcomes (8)
Level of anxiety
Level of anxiety is measured by the State-Trait Anxiety Inventory (Form Y) scale
Measured: The day of the colonoscopy, before the exam
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.
Measured: During the consultation before the colonoscopy
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.
Measured: Up to 24 hours the day of colonoscopy
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.
Measured: The day of colonoscopy from the start to the end of the exam
Rate of polyps resected
compare the rate of resected polyps between the two groups
Measured: The day of colonoscopy from the start to the end of the exam
Rate of complications
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
Measured: To the day of the exam to 8 days after
Patient satisfaction
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.
Measured: Up to 24 hours the day of the colonoscopy
Medico economic criteria
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%).
Measured: To the day of the exam to 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start31 Jan 2022
- Primary completion7 Feb 2028 (estimated)
- Study completion7 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Driffa MOUSSATA, PhD, Principal investigator, University Hospital Center of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051046
- Sponsor's protocol ID
- DR200072
- Acronym
- CODEPICCH
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05051046
- Acronym / sponsor ID
- CODEPICCH / DR200072
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 7 Feb 2028 (estimated)
- Study completion
- 7 Feb 2028 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Procedure: Colonoscopy under hypnosis |
| General anesthesia | No intervention | –Common practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy under hypnosisThe hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation. | Procedure or surgery | Hypnosis |
Primary outcome
Rate of complete colonoscopies
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.
8 secondary outcomes
Level of anxiety
Time frame: The day of the colonoscopy, before the exam
Level of pain
Time frame: During the consultation before the colonoscopy
Level of pain
Time frame: Up to 24 hours the day of colonoscopy
Duration of colonoscopy
Time frame: The day of colonoscopy from the start to the end of the exam
Rate of polyps resected
Time frame: The day of colonoscopy from the start to the end of the exam
Rate of complications
Time frame: To the day of the exam to 8 days after
Patient satisfaction
Time frame: Up to 24 hours the day of the colonoscopy
Medico economic criteria
Time frame: To the day of the exam to 3 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Driffa MOUSSATA, PhD principal investigator
University Hospital Center of Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy under hypnosis in people with Colorectal (Colon or Rectal) Cancer, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Driffa MOUSSATA, PhD (+33 2 47 47 83 50, D.MOUSSATA@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete colonoscopies (time frame: The day of the colonoscopy, from the start to the end of the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.