Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials

Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05546307

Acronym

RELAXPE

Enrollment

242

Registered

2022-09-19

Start date

2022-09-15

Completion date

2025-07-31

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Experience, Relaxation, Somatosensory Evoked Potentials

Keywords

Relaxation, Somatosensory Evoked Potentials, Patient experience

Brief summary

Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation. The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination. The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience

Interventions

OTHERSSEP

Every patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group)

OTHERrelaxation session

The relaxation session will be performed by one of the 5 nurses trained in relaxation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Any patient addressed for a study of the somatosensory evoked potentials in upper limbs * Patients between 18 to 70 years old. * Patients able to understand the instructions of the relaxation session and the examination. * Patient providing informed consent

Design outcomes

Primary

Measure	Time frame	Description
Variation of average rate of automatized artifacts rejection between both groups	19 months	Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave

Countries

France

Contacts

Primary ContactCaroline CARRE

carre.caroline@chu-amiens.fr03 22 08 77 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026