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Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

NCT05108961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-14

No results posted yet for this study

Summary

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.

Conditions

  • Acupuncture
  • Healthy Volunteers

Interventions

PROCEDURE

Acupuncture

one session with precise acupunture points

BEHAVIORAL

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)

BEHAVIORAL

a relaxation questionnaire

The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale

DIAGNOSTIC_TEST

Bispectral Index

BIS is based on an EEG analysis algorithm

Sponsors & Collaborators

  • European Clinical Trial Experts Network

    collaborator OTHER

  • Clinique saint martin Pessac

    collaborator UNKNOWN

  • Elsan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2022-12-13
Completion
2023-01-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108961 on ClinicalTrials.gov