DiscomfortI-SLEPTNCT01095705
Hypnosis for Transesophageal Echocardiography
A study testing Conventional procedure and Conventional procedure + Hypnosis in people with Discomfort, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discomfort
- What is being tested?
- Conventional procedure and Conventional procedure + Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Feb 2011
- 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
- Patient with indication for a Transesophageal Echo (TEE)
- Patient competent to provide written informed consent
Who cannot join
- Patient not subscribed to French Social Security System
- Patient non-French speaking
- Age < 18 years
- Follow-up not possible
- patient declared non competent to give informed consent for the study
- History of severe personality disorder
Show all 10Show fewer
- Patient with a psychiatric treatment started 30 days before the exam
- Patient pregnant or breast-feeding
- Emergency TEE
- Other indication for general anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler
Paris, 75010
About this study
Official title: Utility of Hypnosis for Transesophageal Echocardiography
The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).
Read the detailed description
TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.
- Conditions
- Discomfort
- Being tested
- Conventional procedure, Conventional procedure + Hypnosis
- Keywords
- Hypnosis, Transesophageal Echocardiography, Efficiency of Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional procedureProcedure or surgery
Local anaesthesia (Lidocaïne)
Conventional procedure + HypnosisProcedure or surgery
Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Conventional procedure | Active comparator | Local anaesthesia (Lidocaïne) Receives: Procedure: Conventional procedure |
| Conventional procedure + Hypnosis | Experimental | Local anaesthesia (Lidocaïne) and Hypnosis Receives: Procedure: Conventional procedure + Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of patient comfort
Visual Analogic Scale
Measured: at Day 0
Secondary outcomes (3)
Rate of procedure failure or non-diagnostic study
Measured: at Day 0
Duration of the procedure
Measured: at Day 0
Quality of the procedure as assessed by the operator
Measured: at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiscomfortStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TOURNOUX, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095705
- Sponsor's protocol ID
- P090802
- Other IDs
- 2009-A01156-51
- Acronym
- I-SLEPT
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Hypnosis for Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT01095705
- Acronym / sponsor ID
- I-SLEPT / P090802
- Conditions
- Discomfort
- Keywords
- Hypnosis, Transesophageal Echocardiography, Efficiency of Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Mar 2010 (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 the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).
Detailed description
TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional procedure | Active comparator | Procedure: Conventional procedureLocal anaesthesia (Lidocaïne) |
| Conventional procedure + Hypnosis | Experimental | Procedure: Conventional procedure + HypnosisLocal anaesthesia (Lidocaïne) and Hypnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with indication for a Transesophageal Echo (TEE)
- Patient competent to provide written informed consent
Key exclusion criteria (10 listed)
- Patient not subscribed to French Social Security System
- Patient non-French speaking
- Age < 18 years
- Follow-up not possible
- patient declared non competent to give informed consent for the study
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 |
|---|---|---|
| Conventional procedureLocal anaesthesia (Lidocaïne) | Procedure or surgery | Conventional procedure |
| Conventional procedure + HypnosisLocal anaesthesia (Lidocaïne) + Hypnosis (20 minutes) | Procedure or surgery | Conventional procedure + Hypnosis |
Primary outcome
Level of patient comfort
Time frame: at Day 0
Visual Analogic Scale
3 secondary outcomes
Rate of procedure failure or non-diagnostic study
Time frame: at Day 0
Duration of the procedure
Time frame: at Day 0
Quality of the procedure as assessed by the operator
Time frame: at Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
François TOURNOUX, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional procedure and Conventional procedure + Hypnosis in people with Discomfort, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Dec 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of patient comfort (time frame: at Day 0). 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 19 Dec 2013.