Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No availability of a technician trained in relaxation
Patient's refusal to participate in the protocol
Trial design
Design model
Parallel
Treatments tested in this trial
SSEP
Other interventionEvery 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)
relaxation session
Other interventionThe relaxation session will be performed by one of the 5 nurses trained in relaxation
Treatment groups
242 Participants
are divided into 2 treatment groupsGroup A: one relaxation session before the examinationExperimental treatment 2 interventions
Group B: No relaxation session before the examinationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Variation of average rate of automatized artifacts rejection between both groups
Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave
Time frame
19 monthsSponsors and contacts
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Source ClinicalTrials.gov