Colorectal NeoplasmsNCT05203978
Virtual Reality Colonoscopy : a Study From Nancy
An observational study of Colorectal Neoplasms and Colorectal Polyp, run by Central Hospital, Nancy, France.
Trial summary
Colonoscopy is an exam which can be responsible for pain and discomfort for the patient. Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Polyp
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient needed planned colonoscopy and able to fill in questionnaires in French
Who may be able to join
- patient needed planned colonoscopy
- able to fill in questionnaires in French
Who cannot join
- visual or auditor impairments
- dementia patient
- limited French language skills
- diagnosis of balance disorders or epilepsy
About this study
Colonoscopy is an exam which can be responsible for pain and discomfort for the patient.
Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients.
Besides, monitoring patients during and after sedation is both logistically demanding and costly.
Virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort.
The aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.
Read the detailed description
The study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.
- Conditions
- Colorectal Neoplasms, Colorectal Polyp
- Being tested
- colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality colonoscopy | using virtual reality with glasses and sound no anaesthesia Receives: Procedure: colonoscopy | |
| General anaesthesia colonoscopy | gold standard Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
found of the report
Measured: baseline
Secondary outcomes (5)
Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)
asked on the questionnaire
Measured: baseline
Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)
asked on the questionnaire
Measured: baseline
Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort
asked on the questionnaire
Measured: baseline
Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)
asked on the questionnaire
Measured: baseline
Polyp removal (binary criterion : yes or no)
found on the report
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Baptiste CHEVAUX, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203978
- Sponsor's protocol ID
- 2021PI080
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Colonoscopy : a Study From Nancy
- ClinicalTrials.gov ID
- NCT05203978
- Acronym / sponsor ID
- 2021PI080
- Conditions
- Colorectal Neoplasms, Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Jan 2022 (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.
Colonoscopy is an exam which can be responsible for pain and discomfort for the patient.
Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients.
Besides, monitoring patients during and after sedation is both logistically demanding and costly.
Virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort.
The aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.
Detailed description
The study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality colonoscopy | – | Procedure: colonoscopyusing virtual reality with glasses and sound no anaesthesia |
| General anaesthesia colonoscopy | – | Procedure: colonoscopygold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient needed planned colonoscopy and able to fill in questionnaires in French
Key inclusion criteria (2 listed)
- patient needed planned colonoscopy
- able to fill in questionnaires in French
Key exclusion criteria (4 listed)
- visual or auditor impairments
- dementia patient
- limited French language skills
- diagnosis of balance disorders or epilepsy
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 |
|---|---|---|
| colonoscopyColonoscopy | Procedure or surgery | General anaesthesia colonoscopy, Virtual reality colonoscopy |
Primary outcome
Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
Time frame: baseline
found of the report
5 secondary outcomes
Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)
Time frame: baseline
Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)
Time frame: baseline
Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort
Time frame: baseline
Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)
Time frame: baseline
Polyp removal (binary criterion : yes or no)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Colorectal Polyp, run by Central Hospital, Nancy, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete colonoscopy defined by caecum intubation (binary criterion : yes or no) (time frame: baseline). 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 8 Mar 2022.