NCT05108961

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

Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-04-19
• Primary completion: 2022-12-13
• Completion: 2023-01-13
• First posted: 2021-11-05
• Last updated: 2023-02-14

Locations

1 site across 1 country: France