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| Name | Class |
|---|---|
| European Clinical Trial Experts Network | OTHER |
| Clinique saint martin Pessac | UNKNOWN |
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To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture arm | Experimental | One session of acupuncture with precise acupuncture points |
|
| Sham acupuncture arm | Sham Comparator | One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points) |
|
| Control arm | Placebo Comparator | One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | one session with precise acupunture points |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bispectral Index | Bispectral Index (BIS) measured every second for 35 min through an EEG | 35 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Martin | Pessac | 33600 | France |
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| A digital stress scale |
| Behavioral |
The digital stress scale before and after the session: Oral digital scale. The doctor asks the participant to quantify their anxiety on a virtual scale ranging from 0 (absent anxiety) to 10 (maximum anxiety imaginable) |
|
| a relaxation questionnaire | Behavioral | The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale |
|
| Bispectral Index | Diagnostic Test | BIS is based on an EEG analysis algorithm |
|
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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