|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02818101 |
|
Date of registration:
|
30/03/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Hypnosis Efficacy for the Prevention of Anxiety During a Coronary Angiography
HypCor |
|
Scientific title:
|
|
|
Date of first enrolment:
|
March 2016 |
|
Target sample size:
|
169 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02818101 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Coronary Angiography
|
|
Intervention(s)
|
|
Behavioral: Hypnosis session
|
|
Primary Outcome(s)
|
|
State Anxiety
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
Heart rate
[Time Frame: 1 day]
|
|
Blood pressure
[Time Frame: 1 day]
|
|
Comfort for the operator of the angiography
[Time Frame: 1 day]
|
|
Major complications
[Time Frame: 1 day]
|
|
dose of sedative drugs
[Time Frame: 1 day]
|
|
Pain
[Time Frame: 1 day]
|
|
Secondary ID(s)
|
|
2016-02-CHRMT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|