Coronary Angiography Clinical Trial
— HypCorNCT number | NCT02818101 |
Other study ID # | 2016-02-CHRMT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | May 2018 |
Verified date | March 2016 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic examination. The technique would be an alternative to prevent the consumption of anesthesic drugs.
Status | Completed |
Enrollment | 169 |
Est. completion date | May 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult - coronary angiography scheduled with or without stenting - registered with a social security scheme - people informed clearly by the investigator Exclusion Criteria: - coronary angiography already performed - not well french speaking and understanding - with functional disabilities (mental disorder, ...) - known background of schizophrenia - deaf or hard of hearing - patient under legally protection |
Country | Name | City | State |
---|---|---|---|
France | Chr Metz Thionville | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | State Anxiety | Spielberger State-Trait Anxiety Inventory (STAI): | 1 day | |
Secondary | Comfort for the operator of the angiography | Likert scale into 5 points | 1 day | |
Secondary | Pain | visual analogue pain scale | 1 day | |
Secondary | Heart rate | beats per minute (bpm) | 1 day | |
Secondary | Blood pressure | mmHg | 1 day | |
Secondary | Major complications | beats per minutes | 1 day | |
Secondary | dose of sedative drugs | mg | 1 day |
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