Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
NCT ID: NCT05108961
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-04-19
2023-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Acupuncture arm
One session of acupuncture with precise acupuncture points
Acupuncture
one session with precise acupunture points
A digital stress scale
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
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Bispectral Index
BIS is based on an EEG analysis algorithm
Sham acupuncture arm
One session of sham acupunture (needles inserted 1 mm, outside the acupuncture points)
A digital stress scale
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
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Bispectral Index
BIS is based on an EEG analysis algorithm
Control arm
One session where no needles are inserted, the subject lies down under the same conditions as group 1 and 2
A digital stress scale
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
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Bispectral Index
BIS is based on an EEG analysis algorithm
Interventions
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Acupuncture
one session with precise acupunture points
A digital stress scale
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
The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale
Bispectral Index
BIS is based on an EEG analysis algorithm
Eligibility Criteria
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Inclusion Criteria
* Over 18 years old and less than 65.
* Having given his express consent
* Affiliated to a social security scheme or beneficiary of such a scheme
Exclusion Criteria
* Psychotropic treatment
* narcolepsy
* Obstructive sleep apnea syndrome
* Symptoms that may correspond to COVID 19
* Nickel allergy
* Refusal to participate in the study
* Protected subjects : Adults under guardianship, curatorship or other legal protection deprived of their liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Subject hospitalized without consent
18 Years
65 Years
ALL
Yes
Sponsors
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European Clinical Trial Experts Network
OTHER
Clinique saint martin Pessac
UNKNOWN
Elsan
OTHER
Responsible Party
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Locations
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Clinique Saint Martin
Pessac, , France
Countries
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Other Identifiers
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2021-A01814-37
Identifier Type: -
Identifier Source: org_study_id
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