ColonoscopyNCT00913861
Non-pharmacological Intervention for Colonoscopy
A study testing hypnosis, standard sedation and Structured attention in people with Colonoscopy and Sedation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Sedation, Hypnosis
- What is being tested?
- hypnosis, standard sedation and Structured attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2009to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- patients classified as ASA 1 to 3
- colonoscopy with anesthesiological support
- capacity of consenting
Who cannot join
- pregnancy
- colonoscopy with gastroscopy
- emergency
- psychotic diseases
- deafness
- incapacity to understand french
- addiction of drugs and alcohol
- psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Anesthesiology, University Hospitals of Geneva
Geneva, Canton of Geneva, CH-1211
About this study
Official title: Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.
Read the detailed description
Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.
- Conditions
- Colonoscopy, Sedation, Hypnosis
- Being tested
- hypnosis, standard sedation, Structured attention
- Keywords
- endoscopy, comfort, non-pharmacological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
Also called hypnotic state
Hypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation.
standard sedationDrug
Also called Disoprivan (propofol)and fentanyl
Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
Structured attentionBehavioural
Also called psychological support
Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.
| Study group | Role | What they receive |
|---|---|---|
| standard sedation | Active comparator | propofol and fentanyl Receives: Drug: standard sedation |
| structured attention-standard sedation | Active comparator | structured attention Receives: Behavioral: Structured attention |
| hypnosis-standard sedation | Experimental | hypnosis Receives: Behavioral: hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose of propofol
Measured: the day of the colonoscopy, at the end
Secondary outcomes (6)
gastroenterologist's satisfaction and quality of the colonoscopy
Measured: the day of the procedure, at the end of the procedure
vital parameters
Measured: during all the procedure, every 5 minutes
patient's comfort
Measured: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy
anxiety state
Measured: between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure
patient's satisfaction
Measured: between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy
duration of the procedure
Measured: the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: affiliation's change of the principal investigator need a new review bord
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheseaux Nicole, University Hospital, Geneva
- Investigators
- Nicole Cheseaux, MD, Principal investigator, Division of Anesthesiology, University Hospitals, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913861
- Sponsor's protocol ID
- 08-238
- Other IDs
- NAC 08-072
- Status last verified
- Jun 2014
- First submitted
- 22 May 2009
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
- ClinicalTrials.gov ID
- NCT00913861
- Acronym / sponsor ID
- 08-238
- Conditions
- Colonoscopy, Sedation, Hypnosis
- Keywords
- endoscopy, comfort, non-pharmacological
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: affiliation's change of the principal investigator need a new review bord
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jun 2009 (estimated)
- 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.
The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.
Detailed description
Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard sedation | Active comparator | Drug: standard sedationpropofol and fentanyl |
| structured attention-standard sedation | Active comparator | Behavioral: Structured attentionstructured attention |
| hypnosis-standard sedation | Experimental | Behavioral: hypnosishypnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients classified as ASA 1 to 3
- colonoscopy with anesthesiological support
- capacity of consenting
Key exclusion criteria (8 listed)
- pregnancy
- colonoscopy with gastroscopy
- emergency
- psychotic diseases
- deafness
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 |
|---|---|---|
| hypnosisAlso: hypnotic stateHypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation. | Behavioural | hypnosis-standard sedation |
| standard sedationAlso: Disoprivan (propofol)and fentanylStandard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0. | Drug | standard sedation |
| Structured attentionAlso: psychological supportStructured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations. | Behavioural | structured attention-standard sedation |
Primary outcome
total dose of propofol
Time frame: the day of the colonoscopy, at the end
6 secondary outcomes
gastroenterologist's satisfaction and quality of the colonoscopy
Time frame: the day of the procedure, at the end of the procedure
vital parameters
Time frame: during all the procedure, every 5 minutes
patient's comfort
Time frame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy
anxiety state
Time frame: between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure
patient's satisfaction
Time frame: between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy
duration of the procedure
Time frame: the day of the procedure
Results and safety
The study was stopped early (reason given: affiliation's change of the principal investigator need a new review bord). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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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.
Nicole Cheseaux, MD principal investigator
Division of Anesthesiology, University Hospitals, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis, standard sedation and Structured attention in people with Colonoscopy and Sedation, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 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: stopped early, as of the sponsor's last update on 3 Jun 2014. 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 Switzerland. 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?
The study was stopped early (reason given: affiliation's change of the principal investigator need a new review bord). 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?
total dose of propofol (time frame: the day of the colonoscopy, at the end). 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 3 Jun 2014.